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Trial record 1 of 1 for:    NCT00329550
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Maintenance Study of Certolizumab Pegol (CZP) in Crohn's Disease

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ClinicalTrials.gov Identifier: NCT00329550
Recruitment Status : Completed
First Posted : May 24, 2006
Results First Posted : November 10, 2009
Last Update Posted : March 18, 2015
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Japan Co. Ltd. )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Crohn's Disease
Intervention Biological: Certolizumab pegol (CZP)
Enrollment 40
Recruitment Details Recruitment into this extension study was between March 2006 and April 2008. Of the 26 hospitals and medical centers throughout Japan in the main study, 16 sites went on to enter subjects in this extension study.
Pre-assignment Details To enter this single-group extension study, C87047 (NCT00329550), subjects had to have responded at Week 6 of the double-blind main study, C87037 (NCT00291668). Recruitment details are provided for the 40 subjects who entered this extension study by the three possible treatment sequences received across both studies.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Period Title: Overall Study
Started 9 15 16 [1]
Completed 5 11 12
Not Completed 4 4 4
Reason Not Completed
Adverse Event             3             4             2
Withdrawal of Consent             1             0             1
Due to Relocation             0             0             1
[1]
1 subject in Safety Set is not in Full Analysis Set due to Good Clinical Practice non-compliance.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg Total
Hide Arm/Group Description Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) Total of all reporting groups
Overall Number of Baseline Participants 9 15 16 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 15 participants 16 participants 40 participants
<=18 years
1
  11.1%
3
  20.0%
2
  12.5%
6.0
Between 18 and 65 years
8
  88.9%
12
  80.0%
14
  87.5%
34.0
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0.0
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 15 participants 16 participants 40 participants
32.7  (10.4) 29.3  (9.1) 33.3  (10.0) 31.7  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 15 participants 16 participants 40 participants
Female
2
  22.2%
3
  20.0%
4
  25.0%
9.0
Male
7
  77.8%
12
  80.0%
12
  75.0%
31.0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 9 participants 15 participants 16 participants 40 participants
9 15 16 40
1.Primary Outcome
Title Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 26
Hide Description CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Time Frame Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 9 15 15
Measure Type: Number
Unit of Measure: Percentage of subjects
Percentage of CDAI responders 44.4 73.3 60.0
Percentage of CDAI non-responders 55.6 26.7 40.0
2.Secondary Outcome
Title Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 8
Hide Description CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 9 15 15
Mean (Standard Deviation)
Unit of Measure: score on a scale
-126.7  (100.9) -124.9  (76.7) -141.8  (62.4)
3.Secondary Outcome
Title Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 12
Hide Description CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 8 14 15
Mean (Standard Deviation)
Unit of Measure: score on a scale
-152.6  (96.8) -145.4  (80.5) -152.8  (54.7)
4.Secondary Outcome
Title Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 16
Hide Description CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 8 13 14
Mean (Standard Deviation)
Unit of Measure: score on a scale
-162.8  (98.9) -142.2  (84.3) -143.3  (69.6)
5.Secondary Outcome
Title Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 20
Hide Description CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 6 12 14
Mean (Standard Deviation)
Unit of Measure: score on a scale
-147.0  (38.8) -149.4  (85.6) -130.7  (70.1)
6.Secondary Outcome
Title Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 24
Hide Description CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 6 11 13
Mean (Standard Deviation)
Unit of Measure: score on a scale
-158.6  (53.7) -153.3  (53.7) -138.9  (80.0)
7.Secondary Outcome
Title Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 26
Hide Description CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 5 11 12
Mean (Standard Deviation)
Unit of Measure: score on a scale
-131.1  (32.8) -173.8  (46.5) -153.1  (70.8)
8.Secondary Outcome
Title Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Last Visit [Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals]
Hide Description CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 7 13 13
Mean (Standard Deviation)
Unit of Measure: score on a scale
-132.7  (62.6) -143.2  (88.5) -152.5  (67.9)
9.Secondary Outcome
Title Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 8
Hide Description CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Time Frame Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 9 15 15
Measure Type: Number
Unit of Measure: Percentage of subjects
Percentage of CDAI responders 55.6 66.7 80.0
Percentage of CDAI non-responders 44.4 33.3 20.0
10.Secondary Outcome
Title Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 12
Hide Description CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Time Frame Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 9 15 15
Measure Type: Number
Unit of Measure: Percentage of subjects
Percentage of CDAI responders 77.8 73.3 86.7
Percentage of CDAI non-responders 22.2 26.7 13.3
11.Secondary Outcome
Title Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 16
Hide Description CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Time Frame Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 9 15 15
Measure Type: Number
Unit of Measure: Percentage of subjects
Percentage of CDAI responders 77.8 60.0 66.7
Percentage of CDAI non-responders 22.2 40.0 33.3
12.Secondary Outcome
Title Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 20
Hide Description CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Time Frame Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 9 15 15
Measure Type: Number
Unit of Measure: Percentage of subjects
Percentage of CDAI responders 66.7 60.0 60.0
Percentage of CDAI non-responders 33.3 40.0 40.0
13.Secondary Outcome
Title Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 24
Hide Description CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Time Frame Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 9 15 15
Measure Type: Number
Unit of Measure: Percentage of subjects
Percentage of CDAI responders 44.4 60.0 53.3
Percentage of CDAI non-responders 55.6 40.0 46.7
14.Secondary Outcome
Title Percentage of Crohn's Disease Activity Index (CDAI) Responders at Last Visit [Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals]
Hide Description CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Time Frame Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 9 15 15
Measure Type: Number
Unit of Measure: Percentage of subjects
Percentage of CDAI responders 44.4 73.3 60.0
Percentage of CDAI non-responders 55.6 26.7 40.0
15.Secondary Outcome
Title Percentage of Subjects Achieving Remission at Week 8
Hide Description The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Time Frame Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 9 15 15
Measure Type: Number
Unit of Measure: Percentage of subjects
Percentage of subjects in remission 33.3 40.0 53.3
Percentage of subjects not in remission 66.7 60.0 46.7
16.Secondary Outcome
Title Percentage of Subjects Achieving Remission at Week 12
Hide Description The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Time Frame Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 9 15 15
Measure Type: Number
Unit of Measure: Percentage of subjects
Percentage of subjects in remission 44.4 46.7 53.3
Percentage of subjects not in remission 55.6 53.3 46.7
17.Secondary Outcome
Title Percentage of Subjects Achieving Remission at Week 16
Hide Description The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Time Frame Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 9 15 15
Measure Type: Number
Unit of Measure: Percentage of subjects
Percentage of subjects in remission 44.4 46.7 40.0
Percentage of subjects not in remission 55.6 53.3 60.0
18.Secondary Outcome
Title Percentage of Subjects Achieving Remission at Week 20
Hide Description The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Time Frame Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 9 15 15
Measure Type: Number
Unit of Measure: Percentage of subjects
Percentage of subjects in remission 22.2 53.3 40.0
Percentage of subjects not in remission 77.8 46.7 60.0
19.Secondary Outcome
Title Percentage of Subjects Achieving Remission at Week 24
Hide Description The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Time Frame Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 9 15 15
Measure Type: Number
Unit of Measure: Percentage of subjects
Percentage of subjects in remission 22.2 46.7 40.0
Percentage of subjects not in remission 77.8 53.3 60.0
20.Secondary Outcome
Title Percentage of Subjects Achieving Remission at Week 26
Hide Description The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Time Frame Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 9 15 15
Measure Type: Number
Unit of Measure: Percentage of subjects
Percentage of subjects in remission 22.2 46.7 46.7
Percentage of subjects not in remission 77.8 53.3 53.3
21.Secondary Outcome
Title Percentage of Subjects Achieving Remission at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals)
Hide Description The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Time Frame Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 9 15 15
Measure Type: Number
Unit of Measure: Percentage of subjects
Percentage of subjects in remission 22.2 46.7 46.7
Percentage of subjects not in remission 77.8 53.3 53.3
22.Secondary Outcome
Title Time to Disease Progression
Hide Description

Time to disease progression is defined as the earliest of:

  • time to an increase from Week 6 of ≥100 points in Crohn's Disease Activity Index (CDAI) score and CDAI >175 points for at least 2 consecutive visits,
  • time to use of rescue therapy, or,
  • time to subject withdrawal from the study.
Time Frame Week 6 to Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 6' is the last visit in the double-blind main study and 'Week 26' is 18 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of Study C87037 (NCT00291668) could enter this extension study C87047 (NCT00329550). As so few subjects experienced disease progression in this study it was not possible to calculate the median time to disease progression. Please see post-hoc outcome measure 80 where the number of subjects with disease progression is presented.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
23.Secondary Outcome
Title Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score
Hide Description The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
Time Frame Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 9 15 15
Mean (Standard Deviation)
Unit of Measure: score on a scale
33.8  (25.6) 30.4  (25.8) 23.7  (20.3)
24.Secondary Outcome
Title Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score
Hide Description The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
Time Frame Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 8 14 15
Mean (Standard Deviation)
Unit of Measure: score on a scale
37.6  (27.0) 29.9  (28.6) 25.5  (20.3)
25.Secondary Outcome
Title Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score
Hide Description The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
Time Frame Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 8 13 14
Mean (Standard Deviation)
Unit of Measure: score on a scale
31.0  (31.6) 30.1  (25.4) 22.6  (22.4)
26.Secondary Outcome
Title Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score
Hide Description The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
Time Frame Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 6 12 14
Mean (Standard Deviation)
Unit of Measure: score on a scale
32.2  (20.7) 31.6  (27.6) 19.2  (25.9)
27.Secondary Outcome
Title Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score
Hide Description The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
Time Frame Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 6 11 13
Mean (Standard Deviation)
Unit of Measure: score on a scale
34.0  (13.4) 32.7  (24.6) 23.6  (22.5)
28.Secondary Outcome
Title Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score
Hide Description The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
Time Frame Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 5 11 12
Mean (Standard Deviation)
Unit of Measure: score on a scale
33.4  (17.0) 38.4  (27.0) 28.2  (19.5)
29.Secondary Outcome
Title Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score
Hide Description The Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
Time Frame Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 7 13 13
Mean (Standard Deviation)
Unit of Measure: score on a scale
28.0  (21.5) 33.3  (27.7) 26.1  (20.1)
30.Secondary Outcome
Title Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score
Hide Description The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Time Frame Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 9 15 15
Mean (Standard Deviation)
Unit of Measure: score on a scale
10.7  (5.8) 10.3  (8.6) 9.5  (10.2)
31.Secondary Outcome
Title Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score
Hide Description The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Time Frame Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 8 14 15
Mean (Standard Deviation)
Unit of Measure: score on a scale
12.6  (6.9) 10.2  (10.8) 9.8  (8.5)
32.Secondary Outcome
Title Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score
Hide Description The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Time Frame Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 8 13 14
Mean (Standard Deviation)
Unit of Measure: score on a scale
9.9  (8.3) 8.8  (9.6) 6.7  (7.2)
33.Secondary Outcome
Title Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score
Hide Description The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Time Frame Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 6 12 14
Mean (Standard Deviation)
Unit of Measure: score on a scale
9.5  (8.3) 11.3  (9.7) 6.7  (8.8)
34.Secondary Outcome
Title Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score
Hide Description The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Time Frame Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 6 11 13
Mean (Standard Deviation)
Unit of Measure: score on a scale
11.0  (3.0) 10.4  (8.7) 8.0  (9.5)
35.Secondary Outcome
Title Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score
Hide Description The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Time Frame Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 5 11 12
Mean (Standard Deviation)
Unit of Measure: score on a scale
11.6  (4.2) 12.0  (10.4) 8.8  (9.9)
36.Secondary Outcome
Title Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score
Hide Description The Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Time Frame Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 7 13 13
Mean (Standard Deviation)
Unit of Measure: score on a scale
9.6  (5.8) 10.7  (10.1) 8.1  (9.8)
37.Secondary Outcome
Title Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score
Hide Description The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Time Frame Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 9 15 15
Mean (Standard Deviation)
Unit of Measure: score on a scale
7.6  (7.0) 7.1  (5.9) 5.7  (4.7)
38.Secondary Outcome
Title Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score
Hide Description The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Time Frame Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 8 14 15
Mean (Standard Deviation)
Unit of Measure: score on a scale
7.4  (7.8) 7.4  (6.0) 5.9  (5.4)
39.Secondary Outcome
Title Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score
Hide Description The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Time Frame Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 8 13 14
Mean (Standard Deviation)
Unit of Measure: score on a scale
6.8  (9.1) 7.9  (5.9) 5.9  (6.5)
40.Secondary Outcome
Title Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score
Hide Description The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Time Frame Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 6 12 14
Mean (Standard Deviation)
Unit of Measure: score on a scale
7.5  (3.4) 7.3  (6.6) 4.9  (6.2)
41.Secondary Outcome
Title Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score
Hide Description The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Time Frame Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 6 11 13
Mean (Standard Deviation)
Unit of Measure: score on a scale
8.2  (3.1) 7.5  (6.7) 6.2  (3.5)
42.Secondary Outcome
Title Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score
Hide Description The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Time Frame Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 5 11 12
Mean (Standard Deviation)
Unit of Measure: score on a scale
6.4  (3.5) 8.7  (5.6) 7.2  (3.6)
43.Secondary Outcome
Title Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score
Hide Description The Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Time Frame Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 7 13 13
Mean (Standard Deviation)
Unit of Measure: score on a scale
5.1  (6.8) 8.8  (5.1) 7.2  (3.4)
44.Secondary Outcome
Title Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score
Hide Description The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Time Frame Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 9 15 15
Mean (Standard Deviation)
Unit of Measure: score on a scale
9.4  (7.0) 7.5  (8.6) 5.1  (8.7)
45.Secondary Outcome
Title Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score
Hide Description The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Time Frame Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 8 14 15
Mean (Standard Deviation)
Unit of Measure: score on a scale
10.8  (7.6) 7.7  (8.2) 5.4  (9.6)
46.Secondary Outcome
Title Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score
Hide Description The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Time Frame Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 8 13 14
Mean (Standard Deviation)
Unit of Measure: score on a scale
8.0  (8.2) 7.8  (8.4) 6.1  (9.6)
47.Secondary Outcome
Title Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score
Hide Description The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Time Frame Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 6 12 14
Mean (Standard Deviation)
Unit of Measure: score on a scale
8.5  (9.4) 6.8  (9.4) 4.1  (10.3)
48.Secondary Outcome
Title Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score
Hide Description The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Time Frame Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 6 11 13
Mean (Standard Deviation)
Unit of Measure: score on a scale
8.3  (6.1) 8.6  (9.1) 6.2  (10.3)
49.Secondary Outcome
Title Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score
Hide Description The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Time Frame Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 5 11 12
Mean (Standard Deviation)
Unit of Measure: score on a scale
9.4  (7.2) 11.3  (11.1) 6.8  (8.6)
50.Secondary Outcome
Title Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score
Hide Description The Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Time Frame Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 7 13 13
Mean (Standard Deviation)
Unit of Measure: score on a scale
7.4  (6.8) 9.0  (11.6) 5.8  (9.0)
51.Secondary Outcome
Title Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score
Hide Description The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Time Frame Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 9 15 15
Mean (Standard Deviation)
Unit of Measure: score on a scale
6.1  (7.4) 5.5  (7.1) 3.5  (4.0)
52.Secondary Outcome
Title Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score
Hide Description The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Time Frame Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 8 14 15
Mean (Standard Deviation)
Unit of Measure: score on a scale
6.9  (7.9) 4.5  (8.9) 4.5  (4.1)
53.Secondary Outcome
Title Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score
Hide Description The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Time Frame Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 8 13 14
Mean (Standard Deviation)
Unit of Measure: score on a scale
6.4  (7.7) 5.6  (7.3) 4.0  (4.2)
54.Secondary Outcome
Title Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score
Hide Description The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Time Frame Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 6 12 14
Mean (Standard Deviation)
Unit of Measure: score on a scale
6.7  (5.8) 6.1  (7.9) 3.6  (5.9)
55.Secondary Outcome
Title Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score
Hide Description The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Time Frame Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 6 11 13
Mean (Standard Deviation)
Unit of Measure: score on a scale
6.5  (6.1) 6.2  (7.8) 3.3  (4.3)
56.Secondary Outcome
Title Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score
Hide Description The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Time Frame Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 5 11 12
Mean (Standard Deviation)
Unit of Measure: score on a scale
6.0  (5.8) 6.4  (7.8) 5.7  (5.2)
57.Secondary Outcome
Title Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score
Hide Description The Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Time Frame Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 7 13 13
Mean (Standard Deviation)
Unit of Measure: score on a scale
5.9  (6.0) 4.8  (8.5) 5.2  (5.2)
58.Secondary Outcome
Title C-Reactive Protein (CRP) Level at Week 0
Hide Description [Not Specified]
Time Frame Week 0 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 0' is the Baseline visit in the double-blind main study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 9 15 15
Geometric Mean (Full Range)
Unit of Measure: mg/L
21.37
(1.0 to 68.0)
26.31
(11.0 to 77.0)
25.88
(5.0 to 92.0)
59.Secondary Outcome
Title C-Reactive Protein (CRP) Level at Week 8
Hide Description [Not Specified]
Time Frame Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 9 15 15
Geometric Mean (Full Range)
Unit of Measure: mg/L
23.80
(6.0 to 67.0)
19.11
(1.0 to 115.0)
11.61
(5.0 to 67.0)
60.Secondary Outcome
Title C-Reactive Protein (CRP) Level at Week 12
Hide Description [Not Specified]
Time Frame Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 8 14 15
Geometric Mean (Full Range)
Unit of Measure: mg/L
12.55
(1.0 to 38.0)
14.91
(1.0 to 100.0)
11.64
(4.0 to 56.0)
61.Secondary Outcome
Title C-Reactive Protein (CRP) Level at Week 16
Hide Description [Not Specified]
Time Frame Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 8 13 14
Geometric Mean (Full Range)
Unit of Measure: mg/L
16.12
(1.0 to 58.0)
16.06
(1.0 to 99.0)
14.05
(5.0 to 76.0)
62.Secondary Outcome
Title C-Reactive Protein (CRP) Level at Week 20
Hide Description [Not Specified]
Time Frame Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 6 12 14
Geometric Mean (Full Range)
Unit of Measure: mg/L
17.16
(0.0 to 47.0)
13.16
(3.0 to 73.0)
17.44
(4.0 to 63.0)
63.Secondary Outcome
Title C-Reactive Protein (CRP) Level at Week 24
Hide Description [Not Specified]
Time Frame Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 6 11 13
Geometric Mean (Full Range)
Unit of Measure: mg/L
10.97
(1.0 to 40.0)
12.44
(1.0 to 77.0)
16.84
(5.0 to 87.0)
64.Secondary Outcome
Title C-Reactive Protein (CRP) Level at Week 26
Hide Description [Not Specified]
Time Frame Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 5 11 12
Geometric Mean (Full Range)
Unit of Measure: mg/L
15.94
(0.0 to 48.0)
9.96
(2.0 to 43.0)
13.11
(4.0 to 78.0)
65.Secondary Outcome
Title C-Reactive Protein (CRP) Level at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals)
Hide Description [Not Specified]
Time Frame Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 7 13 13
Geometric Mean (Full Range)
Unit of Measure: mg/L
19.81
(0.0 to 48.0)
13.12
(2.0 to 81.0)
14.04
(4.0 to 78.0)
66.Secondary Outcome
Title Ratio of C-Reactive Protein (CRP) Level at Week 8 to Week 0
Hide Description [Not Specified]
Time Frame Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 9 15 15
Geometric Mean (Full Range)
Unit of Measure: ratio
1.11
(0.5 to 6.0)
0.73
(0.1 to 5.6)
0.45
(0.1 to 1.4)
67.Secondary Outcome
Title Ratio of C-Reactive Protein (CRP) Level at Week 12 to Week 0
Hide Description [Not Specified]
Time Frame Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 8 14 15
Geometric Mean (Full Range)
Unit of Measure: ratio
0.63
(0.2 to 1.4)
0.55
(0.1 to 1.7)
0.45
(0.1 to 1.4)
68.Secondary Outcome
Title Ratio of C-Reactive Protein (CRP) Level at Week 16 to Week 0
Hide Description [Not Specified]
Time Frame Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 8 13 14
Geometric Mean (Full Range)
Unit of Measure: ratio
0.81
(0.2 to 1.9)
0.59
(0.1 to 1.9)
0.53
(0.3 to 2.4)
69.Secondary Outcome
Title Ratio of C-Reactive Protein (CRP) Level at Week 20 to Week 0
Hide Description [Not Specified]
Time Frame Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 6 12 14
Geometric Mean (Full Range)
Unit of Measure: ratio
0.65
(0.0 to 1.4)
0.53
(0.1 to 1.9)
0.66
(0.1 to 2.0)
70.Secondary Outcome
Title Ratio of C-Reactive Protein (CRP) Level at Week 24 to Week 0
Hide Description [Not Specified]
Time Frame Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 6 11 13
Geometric Mean (Full Range)
Unit of Measure: ratio
0.72
(0.2 to 1.8)
0.5
(0.1 to 1.7)
0.62
(0.1 to 1.8)
71.Secondary Outcome
Title Ratio of C-Reactive Protein (CRP) Level at Week 26 to Week 0
Hide Description [Not Specified]
Time Frame Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 5 11 12
Geometric Mean (Full Range)
Unit of Measure: ratio
0.63
(0.0 to 1.2)
0.4
(0.1 to 1.7)
0.47
(0.1 to 2.5)
72.Secondary Outcome
Title Ratio of C-Reactive Protein (CRP) Level at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) to Week 0
Hide Description [Not Specified]
Time Frame Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 7 13 13
Geometric Mean (Full Range)
Unit of Measure: ratio
0.72
(0.0 to 1.2)
0.48
(0.1 to 1.8)
0.52
(0.1 to 2.5)
73.Secondary Outcome
Title Percentage of Subjects at Week 8 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0
Hide Description CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 9 15 15
Measure Type: Number
Unit of Measure: Percentage of subjects
Percentage of 70-point responders 77.8 73.3 86.7
Percentage of 70-point non-responders 22.2 26.7 13.3
74.Secondary Outcome
Title Percentage of Subjects at Week 12 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0
Hide Description CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 9 15 15
Measure Type: Number
Unit of Measure: Percentage of subjects
Percentage of 70-point responders 77.8 80.0 93.3
Percentage of 70-point non-responders 22.2 20.0 6.7
75.Secondary Outcome
Title Percentage of Subjects at Week 16 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0
Hide Description CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 9 15 15
Measure Type: Number
Unit of Measure: Percentage of subjects
Percentage of 70-point responders 77.8 66.7 66.7
Percentage of 70-point non-responders 22.2 33.3 33.3
76.Secondary Outcome
Title Percentage of Subjects at Week 20 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0
Hide Description CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 9 15 15
Measure Type: Number
Unit of Measure: Percentage of subjects
Percentage of 70-point responders 66.7 60.0 73.3
Percentage of 70-point non-responders 33.3 40.0 26.7
77.Secondary Outcome
Title Percentage of Subjects at Week 24 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0
Hide Description CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 9 15 15
Measure Type: Number
Unit of Measure: Percentage of subjects
Percentage of 70-point responders 55.6 66.7 60.0
Percentage of 70-point non-responders 44.4 33.3 40.0
78.Secondary Outcome
Title Percentage of Subjects at Week 26 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0
Hide Description CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 9 15 15
Measure Type: Number
Unit of Measure: Percentage of subjects
Percentage of 70-point responders 55.6 73.3 73.3
Percentage of 70-point non-responders 44.4 26.7 26.7
79.Secondary Outcome
Title Percentage of Subjects at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0
Hide Description CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 9 15 15
Measure Type: Number
Unit of Measure: Percentage of subjects
Percentage of 70-point responders 55.6 73.3 73.3
Percentage of 70-point non-responders 44.4 26.7 26.7
80.Post-Hoc Outcome
Title Number of Subjects With Disease Progression
Hide Description

Disease progression is defined as:

  • an increase from Week 6 of ≥100 points in Crohn's Disease Activity Index (CDAI) score and CDAI >175 points for at least 2 consecutive visits,
  • use of rescue therapy, or,
  • subject withdrawal from the study.
Time Frame Week 6 to Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 6' is the last visit in the double-blind main study and 'Week 26' is 18 weeks after the first visit in this extension study.
Hide Outcome Measure Data
Hide Analysis Population Description
Responders at Week 6 of Study C87037 (NCT00291668) could enter this extension study, C87047 (NCT00329550). As it was not possible to calculate the time to disease progression (outcome measure 22) due to the very small number of subjects meeting this definition, the post-hoc outcome of number of subjects with disease progression is presented here.
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
Hide Arm/Group Description:
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
Overall Number of Participants Analyzed 9 15 15
Measure Type: Number
Unit of Measure: subjects
2 3 1
Time Frame Adverse event data summarized in the first four columns were collected from the day after the end of the double-blind main study up to and including 12 weeks following the last dose received in this extension study for each subject (i.e., up to 30 weeks).
Adverse Event Reporting Description For the fifth column, 'Total 2', this presents the data summarized in 'Total 1' PLUS adverse event data from the double-blind main study for subjects who received certolizumab pegol (CZP) in the main study and then entered this extension study (i.e., up to 36 weeks).
 
Arm/Group Title CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg Total 1 (This Extension Study Only) Total 2 (Treatment With CZP in Main Study and Extension Study)
Hide Arm/Group Description Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) This includes all adverse event data collected in this extension study for all 40 subjects who entered this extension study. This includes all adverse event data from the 6-week double-blind main study (NCT00291668) and this extension study for all 40 subjects who entered this extension study, whilst they were receiving treatment with certolizumab pegol (CZP) in either study. Adverse events recorded in the double-blind main study (NCT00291668) for subjects who received Placebo treatment during that study are not included here.
All-Cause Mortality
CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg Total 1 (This Extension Study Only) Total 2 (Treatment With CZP in Main Study and Extension Study)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg Total 1 (This Extension Study Only) Total 2 (Treatment With CZP in Main Study and Extension Study)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/9 (22.22%)      5/15 (33.33%)      5/16 (31.25%)      12/40 (30.00%)      13/40 (32.50%)    
Gastrointestinal disorders           
Abdominal pain * 1  0/9 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/40 (0.00%)  0 1/40 (2.50%)  1
Crohn's disease * 1  1/9 (11.11%)  1 4/15 (26.67%)  4 3/16 (18.75%)  3 8/40 (20.00%)  8 8/40 (20.00%)  8
Ileal perforation * 1  1/9 (11.11%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 1/40 (2.50%)  1
Pancreatitis * 1  0/9 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 1/40 (2.50%)  1 1/40 (2.50%)  1
Peritonitis * 1  1/9 (11.11%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 1/40 (2.50%)  1
General disorders           
Pyrexia * 1  0/9 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 1/40 (2.50%)  1 3/40 (7.50%)  3
Psychiatric disorders           
Suicidal ideation * 1  0/9 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 1/40 (2.50%)  1 1/40 (2.50%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg Total 1 (This Extension Study Only) Total 2 (Treatment With CZP in Main Study and Extension Study)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/9 (88.89%)      12/15 (80.00%)      15/16 (93.75%)      35/40 (87.50%)      35/40 (87.50%)    
Blood and lymphatic system disorders           
Iron deficiency anaemia * 1  0/9 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 1/40 (2.50%)  1 1/40 (2.50%)  1
Cardiac disorders           
Bradycardia * 1  0/9 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 1/40 (2.50%)  1 1/40 (2.50%)  1
Tachycardia * 1  1/9 (11.11%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 1/40 (2.50%)  1
Endocrine disorders           
Adrenal insufficiency * 1  1/9 (11.11%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 1/40 (2.50%)  1
Eye disorders           
Chalazion * 1  0/9 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 1/40 (2.50%)  1 1/40 (2.50%)  1
Gastrointestinal disorders           
Abdominal pain * 1  1/9 (11.11%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 1/40 (2.50%)  1
Crohn's disease * 1  1/9 (11.11%)  1 1/15 (6.67%)  1 0/16 (0.00%)  0 2/40 (5.00%)  2 2/40 (5.00%)  2
Glossitis * 1  0/9 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 1/40 (2.50%)  1 1/40 (2.50%)  1
Nausea * 1  2/9 (22.22%)  2 2/15 (13.33%)  2 0/16 (0.00%)  0 4/40 (10.00%)  4 6/40 (15.00%)  6
Toothache * 1  0/9 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 1/40 (2.50%)  1 2/40 (5.00%)  2
Vomiting * 1  2/9 (22.22%)  2 0/15 (0.00%)  0 1/16 (6.25%)  1 3/40 (7.50%)  3 3/40 (7.50%)  3
General disorders           
Feeling abnormal * 1  1/9 (11.11%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 1/40 (2.50%)  1
Generalised oedema * 1  0/9 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 1/40 (2.50%)  1 1/40 (2.50%)  1
Pyrexia * 1  1/9 (11.11%)  1 1/15 (6.67%)  2 1/16 (6.25%)  1 3/40 (7.50%)  4 3/40 (7.50%)  4
Hepatobiliary disorders           
Cholecystitis acute * 1  1/9 (11.11%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 1/40 (2.50%)  1
Hepatic function abnormal * 1  0/9 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 1/40 (2.50%)  1 1/40 (2.50%)  1
Liver disorder * 1  1/9 (11.11%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 1/40 (2.50%)  1
Immune system disorders           
Drug hypersensitivity * 1  1/9 (11.11%)  1 1/15 (6.67%)  1 0/16 (0.00%)  0 2/40 (5.00%)  2 2/40 (5.00%)  2
Seasonal allergy * 1  0/9 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 1/40 (2.50%)  1 1/40 (2.50%)  1
Infections and infestations           
Candidiasis * 1  0/9 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 1/40 (2.50%)  1 1/40 (2.50%)  1
Colitis pseudomembranous * 1  0/9 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 1/40 (2.50%)  1 1/40 (2.50%)  1
Dental caries * 1  0/9 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 1/40 (2.50%)  1 1/40 (2.50%)  1
Herpes zoster * 1  0/9 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 1/40 (2.50%)  1 1/40 (2.50%)  1
Infection * 1  0/9 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 1/40 (2.50%)  1 1/40 (2.50%)  1
Influenza * 1  1/9 (11.11%)  1 1/15 (6.67%)  1 2/16 (12.50%)  2 4/40 (10.00%)  4 4/40 (10.00%)  4
Laryngopharyngitis * 1  1/9 (11.11%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 1/40 (2.50%)  1
Nasopharyngitis * 1  2/9 (22.22%)  4 3/15 (20.00%)  4 10/16 (62.50%)  12 15/40 (37.50%)  20 18/40 (45.00%)  27
Otitis externa * 1  0/9 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 1/40 (2.50%)  1 1/40 (2.50%)  1
Pharyngitis * 1  1/9 (11.11%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 2/40 (5.00%)  2
Rhinitis * 1  0/9 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 1/40 (2.50%)  1 1/40 (2.50%)  1
Urinary tract infection * 1  0/9 (0.00%)  0 2/15 (13.33%)  2 0/16 (0.00%)  0 2/40 (5.00%)  2 2/40 (5.00%)  2
Injury, poisoning and procedural complications           
Contusion * 1  0/9 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 1/40 (2.50%)  1 1/40 (2.50%)  1
Fall * 1  0/9 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 1/40 (2.50%)  1 1/40 (2.50%)  1
Procedural hypotension * 1  1/9 (11.11%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 1/40 (2.50%)  1
Investigations           
Antinuclear antibody increased * 1  1/9 (11.11%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 1/40 (2.50%)  1
Antinuclear antibody positive * 1  0/9 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 1/40 (2.50%)  1 1/40 (2.50%)  1
Blood alkaline phosphatase increased * 1  0/9 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 1/40 (2.50%)  1 1/40 (2.50%)  1
DNA antibody positive * 1  2/9 (22.22%)  2 1/15 (6.67%)  1 2/16 (12.50%)  2 5/40 (12.50%)  5 5/40 (12.50%)  5
White blood cell count decreased * 1  0/9 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 1/40 (2.50%)  1 1/40 (2.50%)  2
Musculoskeletal and connective tissue disorders           
Arthralgia * 1  1/9 (11.11%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 1/40 (2.50%)  1
Musculoskeletal stiffness * 1  0/9 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 1/40 (2.50%)  1 1/40 (2.50%)  1
Myalgia intercostal * 1  0/9 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 1/40 (2.50%)  1 1/40 (2.50%)  1
Pain in extremity * 1  0/9 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 1/40 (2.50%)  1 1/40 (2.50%)  1
Nervous system disorders           
Disgeusia * 1  0/9 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 1/40 (2.50%)  1 1/40 (2.50%)  1
Dizziness * 1  0/9 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 1/40 (2.50%)  1 1/40 (2.50%)  1
Extrapyramidal disorder * 1  0/9 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 1/40 (2.50%)  1 1/40 (2.50%)  1
Headache * 1  0/9 (0.00%)  0 1/15 (6.67%)  1 2/16 (12.50%)  2 3/40 (7.50%)  3 3/40 (7.50%)  3
Hypoaesthesia * 1  1/9 (11.11%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 1/40 (2.50%)  1
Tension headache * 1  0/9 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 1/40 (2.50%)  1 1/40 (2.50%)  1
Psychiatric disorders           
Insomnia * 1  0/9 (0.00%)  0 1/15 (6.67%)  1 1/16 (6.25%)  1 2/40 (5.00%)  2 2/40 (5.00%)  2
Neurosis * 1  0/9 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 1/40 (2.50%)  1 1/40 (2.50%)  1
Respiratory, thoracic and mediastinal disorders           
Hiccups * 1  1/9 (11.11%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 1/40 (2.50%)  1
Pharyngolaryngeal pain * 1  0/9 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 1/40 (2.50%)  1 1/40 (2.50%)  1
Pharynx discomfort * 1  0/9 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 1/40 (2.50%)  1 2/40 (5.00%)  2
Rhinitis allergic * 1  1/9 (11.11%)  1 1/15 (6.67%)  1 0/16 (0.00%)  0 2/40 (5.00%)  2 2/40 (5.00%)  2
Upper respiratory tract inflammation * 1  0/9 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 1/40 (2.50%)  1 2/40 (5.00%)  2
Skin and subcutaneous tissue disorders           
Alopecia areata * 1  1/9 (11.11%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 1/40 (2.50%)  1
Dermatitis psoriasiform * 1  1/9 (11.11%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0 1/40 (2.50%)  1 1/40 (2.50%)  1
Eczema asteatotic * 1  0/9 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 1/40 (2.50%)  1 1/40 (2.50%)  1
Eczema nummular * 1  0/9 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 1/40 (2.50%)  1 1/40 (2.50%)  1
Erythema * 1  0/9 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 1/40 (2.50%)  1 1/40 (2.50%)  1
Seborrhoeic dermatitis * 1  0/9 (0.00%)  0 0/15 (0.00%)  0 2/16 (12.50%)  2 2/40 (5.00%)  2 2/40 (5.00%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
Due to the small number of subjects in this study, the percentages of subjects with adverse events may be misleading.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB Clinical Trial Call Center
Organization: UCB Pharma
Phone: +1 877 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Japan Co. Ltd. )
ClinicalTrials.gov Identifier: NCT00329550    
Other Study ID Numbers: C87047
2014-004354-34 ( EudraCT Number )
First Submitted: May 22, 2006
First Posted: May 24, 2006
Results First Submitted: April 7, 2009
Results First Posted: November 10, 2009
Last Update Posted: March 18, 2015