Maintenance Study of Certolizumab Pegol (CZP) in Crohn's Disease

• 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: UCB Japan Co. Ltd.
• 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

Participant Flow

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
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.

Baseline Characteristics

Arm/Group Title		CZP 400 mg / Placebo	CZP 400 mg / CZP 200 mg	CZP 400 mg / CZP 400 mg	Total
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
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

Outcome Measures

1. Primary Outcome

Title	Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 26
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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]
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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]
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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)
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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)
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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
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.

Outcome Measure Data

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
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

Adverse Events

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)
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	--/--		--/--		--/--		--/--		--/--
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
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

Limitations and Caveats

Due to the small number of subjects in this study, the percentages of subjects with adverse events may be misleading.

More Information

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

• Name/Title: UCB Clinical Trial Call Center
• Organization: UCB Pharma
• Phone: +1 877 822 9493

• 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