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Trial record 1 of 1 for:    NCT00333788
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Follow-up to Welcome Study C87042 [NCT00308581] Examining Certolizumab Pegol (CDP870) in Subjects With Crohn's Disease (Welcome2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00333788
Recruitment Status : Completed
First Posted : June 6, 2006
Results First Posted : July 12, 2011
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

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 (CDP870)
Enrollment 233
Recruitment Details This study started in October 2006, with recruitment in the United States, Austria, Belgium, Canada, France, Germany, Italy, Spain, Sweden, Switzerland, the United Kingdom and the Netherlands. This study completed in April 2010.
Pre-assignment Details The summary of Participant Flow is based on the All Subjects Population.
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Period Title: Overall Study
Started 233 [1]
Completed 71
Not Completed 162
Reason Not Completed
Adverse Event             44
Lack of Efficacy             80
Lost to Follow-up             2
Withdrawal by Subject             24
Other: Non-compliance             2
Other: Moved             2
Other: Recurrent squamaous cell cancer             1
Other: Investigator decision             1
Other: Quality of life concern             1
Other: Sponsor decision             1
Other: Subject in need of an Entocort             1
Other: Medical monitor decision             1
Other: Physician decision             1
Other: Signed consent for another study             1
[1]
Participant flow based on All Subjects population; Baseline characteristics based on ITT population.
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Baseline Participants 229
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 229 participants
<=18 years
1
   0.4%
Between 18 and 65 years
224
  97.8%
>=65 years
4
   1.7%
[1]
Measure Description: Baseline characteristics are based on the ITT population; Participant flow is based on the All Subjects population.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 229 participants
31.8  (11.6)
[1]
Measure Description: Baseline characteristics are based on the ITT population; Participant flow is based on the All Subjects population.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 229 participants
Female
146
  63.8%
Male
83
  36.2%
[1]
Measure Description: Baseline characteristics are based on the ITT population; Participant flow is based on the All Subjects population.
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 229 participants
France 20
United States 70
Canada 20
Spain 6
Belgium 30
Austria 8
Netherlands 2
Germany 34
United Kingdom 9
Switzerland 4
Italy 24
Sweden 2
[1]
Measure Description: Baseline characteristics are based on the ITT population; Participant flow is based on the All Subjects population.
1.Primary Outcome
Title Occurrence of at Least One Study-emergent Adverse Event During the Study (Maximum 164 Weeks)
Hide Description

Study-emergent adverse events are defined as treatment-emergent adverse events with an onset date on or after the first study drug administration date of this study but not later than 12 weeks (84 days) after last injection.

Results are presented as the percentage of subjects with at least one treatment-emergent adverse event during this study.

Time Frame Maximum 164 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description:
400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed 229
Measure Type: Number
Unit of Measure: percentage of participants
92.6
2.Secondary Outcome
Title Maintenance of Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] Among the Subjects in Clinical Response at Baseline of This Study (Week 26 of Study C87042).
Hide Description

Clinical response is defined as at least a 100 point decrease from Baseline of study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI).

Subjects maintained their clinical response at Last Visit if they did not meet criteria for loss of response [CDAI score >150 points and a minimum increase in CDAI of 70 points versus Baseline of study C87042 (NCT00308581)] at 2 consecutive visits.

A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.

Results are presented as the percentage of subjects maintaining response at Last visit.

Time Frame Baseline (corresponding to Week 26 of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 233 subjects in the study, 166 are in the Intent to Treat (ITT) population and were in clinical response at Baseline of this study, and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description:
400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed 166
Measure Type: Number
Unit of Measure: percentage of participants
61.8
3.Secondary Outcome
Title Clinical Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Hide Description

Clinical response is defined as at least a 100 point decrease from Baseline of study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI).

CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.

Results are presented as the percentage of subjects achieving clinical response at Last visit.

Time Frame Baseline of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description:
400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed 229
Measure Type: Number
Unit of Measure: percentage of participants
53.3
4.Secondary Outcome
Title Remission at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Hide Description

Remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points

CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.

Results are presented as the percentage of subjects in remission at Last visit.

Time Frame Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description:
400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed 229
Measure Type: Number
Unit of Measure: percentage of participants
40.6
5.Secondary Outcome
Title Change From Baseline of Study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI) at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Hide Description CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Time Frame Baseline of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 233 subjects in the study, 215 are in the Intent to Treat (ITT) population with Crohn's Disease Activity Index (CDAI) scores at Baseline and Last/Withdrawal visits and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description:
400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed 215
Mean (Standard Deviation)
Unit of Measure: score on a scale
-121.52  (99.61)
6.Secondary Outcome
Title Time to Loss of Response After Baseline of Study C87042 (NCT00308581) on Subjects Who Were in Clinical Response at Baseline of This Study
Hide Description

Clinical response at Baseline of this study of at least a 100 point decrease from Baseline of study C87042 in Crohn's Disease Activity Index (CDAI)

Loss of response = both a CDAI score >150 points and a minimum increase in CDAI of 70 points versus Baseline (Week 26 of study C87042) as confirmed at 2 consecutive visits. Subjects losing response will be considered as having the event on the date of the first visit where response was lost. Subjects who discontinued the study without having lost response will be censored on the date of discontinuation (i.e. date of last visit performed).

Time Frame Maximum 154 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 233 subjects in the study 153 are in the Modified Intent to Treat (MITT) population and are responders at Baseline of this study and are in this analysis. The MITT population includes subjects that are in the ITT population that were correctly randomized at Week 6 of study C87042 (NCT00308581).
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description:
400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed 153
Median (Full Range)
Unit of Measure: days
169.5
(85 to 814)
7.Secondary Outcome
Title Occurrence of at Least 1 Hospital Stay During the Treatment Period
Hide Description

The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.

Results are presented as the percentage of subjects with at least 1 hospital stay during the treatment period.

Time Frame Maximum 152 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description:
400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed 229
Measure Type: Number
Unit of Measure: percentage of participants
21.4
8.Secondary Outcome
Title Occurrence of at Least 1 Hospital Stay During the Follow-Up Period
Hide Description

Follow-up period starts the day after the last injection up to 84 days after last injection.

Results are presented as the percentage of subjects with at least 1 hospital stay during the follow-up period.

Time Frame Maximum 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description:
400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed 229
Measure Type: Number
Unit of Measure: percentage of participants
21.8
9.Secondary Outcome
Title Occurrence of at Least 1 Hospital Stay During the During the Overall Period
Hide Description

Overall period corresponds to both treatment and follow-up periods in C87046.

Results are presented as the percentage of subjects with at least 1 hospital stay during the overall period.

Time Frame Maximum 164 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description:
400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed 229
Measure Type: Number
Unit of Measure: percentage of participants
37.6
10.Secondary Outcome
Title Length of Hospital Stays During the Treatment Period
Hide Description The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.
Time Frame Maximum 152 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description:
400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed 229
Mean (Standard Deviation)
Unit of Measure: days
1.838  (5.785)
11.Secondary Outcome
Title Length of Hospital Stays During the Follow-Up Period
Hide Description Follow-up period starts the day after the last injection up to 84 days after last injection.
Time Frame Maximum 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description:
400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed 229
Mean (Standard Deviation)
Unit of Measure: days
2.782  (7.743)
12.Secondary Outcome
Title Length of Hospital Stays During the Overall Period
Hide Description Overall period corresponds to both treatment and follow-up periods in C87046.
Time Frame Maximum 164 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description:
400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed 229
Mean (Standard Deviation)
Unit of Measure: days
4.620  (9.704)
13.Secondary Outcome
Title Occurrence of at Least 1 Emergency Room Visit During the Treatment Period
Hide Description

The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.

Results are presented as the percentage of subjects with at least 1 emergency room visit during the treatment period.

Time Frame Maximum 152 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description:
400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed 229
Measure Type: Number
Unit of Measure: percentage of participants
13.1
14.Secondary Outcome
Title Occurrence of at Least 1 Emergency Room Visit During the Follow-Up Period
Hide Description

Follow-up period starts the day after the last injection up to 84 days after last injection.

Results are presented as the percentage of subjects with at least 1 emergency room visit during the follow-up period.

Time Frame Maximum 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description:
400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed 229
Measure Type: Number
Unit of Measure: percentage of participants
6.1
15.Secondary Outcome
Title Occurrence of at Least 1 Emergency Room Visit During the Overall Period
Hide Description

Overall period corresponds to both treatment and follow-up periods in C87046.

Results are presented as the percentage of subjects with at least 1 emergency room visit during the overall period.

Time Frame Maximum 164 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description:
400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed 229
Measure Type: Number
Unit of Measure: percentage of participants
19.2
16.Secondary Outcome
Title Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Treatment Period
Hide Description

The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.

Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics.

Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the treatment period.

Time Frame Maximum 152 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description:
400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed 229
Measure Type: Number
Unit of Measure: percentage of participants
Anti tumor necrosis factor (Anti-TNF) 0.4
Immunosuppressants 3.9
Corticosteroids 24.0
5- Aminosalicylic Acid (5-ASA) 5.2
Antibiotics 55.5
17.Secondary Outcome
Title Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Follow-Up Period
Hide Description

Follow-up period start the day after the last injection up to 84 days after last injection.

Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics.

Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the follow-up period.

Time Frame Maximum 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description:
400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed 229
Measure Type: Number
Unit of Measure: percentage of participants
Anti tumor necrosis factor (Anti-TNF) 16.2
Immunosuppresants 5.2
Corticosteroids 15.3
5- Aminosalicylic Acid (5-ASA) 2.2
Antibiotics 14.0
18.Secondary Outcome
Title Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Overall Period
Hide Description

Overall period corresponds to both treatment and follow-up periods in C87046.

Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics.

Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the overall period.

Time Frame Maximum 164 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description:
400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed 229
Measure Type: Number
Unit of Measure: percentage of participants
Anti tumor necrosis factor (Anti-TNF) 16.2
Immunosuppressants 8.3
Corticosteroids 35.4
5- Aminosalicylic Acid (5-ASA) 7.0
Antibiotics 62.4
19.Secondary Outcome
Title Occurrence of at Least 1 General Concomitant Medication During the Treatment Period
Hide Description

The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.

Results are presented as the number of subjects who used at least 1 concomitant medication during the treatment period.

Time Frame Maximum 152 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description:
400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed 229
Measure Type: Number
Unit of Measure: participants
185
20.Secondary Outcome
Title Occurrence of at Least 1 General Concomitant Medication During the Follow-Up Period
Hide Description

Follow-up period start the day after the last injection up to 84 days after last injection.

Results are presented as the number of subjects who used at least 1 concomitant medication during the follow-up period.

Time Frame Maximum 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description:
400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed 229
Measure Type: Number
Unit of Measure: participants
71
21.Secondary Outcome
Title Occurrence of at Least 1 General Concomitant Medication During the Overall Period
Hide Description

Overall period corresponds to both treatment and follow-up periods in C87046.

Results are presented as the number of subjects who used at least 1 concomitant medication during the overall period.

Time Frame Maximum 164 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description:
400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed 229
Measure Type: Number
Unit of Measure: participants
195
22.Secondary Outcome
Title Occurrence of at Least 1 Concurrent Medical Procedure During the Treatment Period.
Hide Description

The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.

Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the treatment period.

Time Frame Maximum 152 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description:
400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed 229
Measure Type: Number
Unit of Measure: participants
148
23.Secondary Outcome
Title Occurrence of at Least 1 Concurrent Medical Procedure During the Follow-Up Period
Hide Description

Follow-up period start the day after the last injection up to 84 days after last injection.

Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the follow-up period.

Time Frame Maximum 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description:
400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed 229
Measure Type: Number
Unit of Measure: participants
84
24.Secondary Outcome
Title Occurrence of at Least 1 Concurrent Medical Procedure During the Overall Period
Hide Description

Overall period corresponds to both treatment and follow-up periods in C87046.

Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the overall period.

Time Frame Maximum 164 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description:
400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Number of Participants Analyzed 229
Measure Type: Number
Unit of Measure: participants
173
Time Frame Maximum of 166 weeks
Adverse Event Reporting Description Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
 
Arm/Group Title Certolizumab Pegol 400 mg
Hide Arm/Group Description 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
All-Cause Mortality
Certolizumab Pegol 400 mg
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Certolizumab Pegol 400 mg
Affected / at Risk (%) # Events
Total   73/229 (31.88%)    
Blood and lymphatic system disorders   
Anaemia * 1  1/229 (0.44%)  1
Cardiac disorders   
Supraventricular tachycardia * 1  1/229 (0.44%)  1
Ear and labyrinth disorders   
Vertigo * 1  1/229 (0.44%)  1
Vertigo positional * 1  1/229 (0.44%)  1
Endocrine disorders   
Diabetes insipidus * 1  1/229 (0.44%)  1
Gastrointestinal disorders   
Abdominal hernia * 1  1/229 (0.44%)  1
Abdominal pain * 1  4/229 (1.75%)  5
Anal fistula * 1  2/229 (0.87%)  2
Ascites * 1  1/229 (0.44%)  1
Colonic stenosis * 1  5/229 (2.18%)  5
Constipation * 1  1/229 (0.44%)  1
Crohn's disease * 1  22/229 (9.61%)  23
Faecal incontinence * 1  1/229 (0.44%)  1
Frequent bowel movements * 1  1/229 (0.44%)  2
Gastrointestinal haemorrhage * 1  1/229 (0.44%)  1
Gastrointestinal obstruction * 1  1/229 (0.44%)  1
Gastrooesophageal reflux disease * 1  1/229 (0.44%)  1
Hernial eventration * 1  1/229 (0.44%)  1
Ileal stenosis * 1  1/229 (0.44%)  1
Intestinal obstruction * 1  2/229 (0.87%)  2
Intestinal stenosis * 1  2/229 (0.87%)  2
Pancreatitis * 1  1/229 (0.44%)  1
Rectal perforation * 1  1/229 (0.44%)  1
Small intestinal obstruction * 1  2/229 (0.87%)  2
Small intestinal stenosis * 1  1/229 (0.44%)  1
Vomiting * 1  1/229 (0.44%)  1
General disorders   
Chest pain * 1  3/229 (1.31%)  3
Pyrexia * 1  1/229 (0.44%)  1
Hepatobiliary disorders   
Cholecystitis * 1  1/229 (0.44%)  1
Hepatitis * 1  1/229 (0.44%)  1
Infections and infestations   
Abdominal abscess * 1  5/229 (2.18%)  5
Abdominal wall abscess * 1  1/229 (0.44%)  1
Anal abscess * 1  2/229 (0.87%)  2
Breast abscess * 1  1/229 (0.44%)  1
Clostridial infection * 1  1/229 (0.44%)  1
Empyema * 1  1/229 (0.44%)  1
Fusobacterium infection * 1  1/229 (0.44%)  1
Gastroenteritis viral * 1  2/229 (0.87%)  2
Infective tenosynovitis * 1  1/229 (0.44%)  1
Parotitis * 1  1/229 (0.44%)  1
Perianal abscess * 1  5/229 (2.18%)  7
Perineal abscess * 1  1/229 (0.44%)  1
Perirectal abscess * 1  1/229 (0.44%)  1
Pneumonia * 1  2/229 (0.87%)  2
Rectal abscess * 1  1/229 (0.44%)  1
Sepsis * 1  1/229 (0.44%)  1
Septic shock * 1  1/229 (0.44%)  1
Tuberculosis * 1  1/229 (0.44%)  1
Urinary tract infection * 1  1/229 (0.44%)  1
Wound infection * 1  1/229 (0.44%)  1
Injury, poisoning and procedural complications   
Anastomotic stenosis * 1  2/229 (0.87%)  3
Gastrointestinal stoma complication * 1  1/229 (0.44%)  1
Incisional hernia * 1  2/229 (0.87%)  2
Tendon rupture * 1  1/229 (0.44%)  1
Wound complication * 1  1/229 (0.44%)  1
Investigations   
Alanine aminotransferase increased * 1  1/229 (0.44%)  1
Weight decreased * 1  2/229 (0.87%)  2
Metabolism and nutrition disorders   
Dehydration * 1  1/229 (0.44%)  1
Hypoalbuminaemia * 1  1/229 (0.44%)  1
Hypokalaemia * 1  2/229 (0.87%)  2
Malnutrition * 1  2/229 (0.87%)  2
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  1/229 (0.44%)  1
Fistula * 1  2/229 (0.87%)  4
Nervous system disorders   
Cerebral infarction * 1  1/229 (0.44%)  1
Dizziness * 1  1/229 (0.44%)  1
Hemiparesis * 1  1/229 (0.44%)  1
Hyporeflexia * 1  1/229 (0.44%)  1
Syncope * 1  1/229 (0.44%)  1
Wallenberg syndrome * 1  1/229 (0.44%)  1
Psychiatric disorders   
Anxiety * 1  1/229 (0.44%)  1
Depression * 1  1/229 (0.44%)  1
Mental disorder * 1  1/229 (0.44%)  1
Renal and urinary disorders   
Bladder prolapse * 1  1/229 (0.44%)  1
Nephrolithiasis * 1  1/229 (0.44%)  1
Renal colic * 1  1/229 (0.44%)  1
Renal failure acute * 1  1/229 (0.44%)  1
Reproductive system and breast disorders   
Ovarian cyst * 1  1/229 (0.44%)  1
Skin and subcutaneous tissue disorders   
Acute febrile neutrophilic dermatosis * 1  1/229 (0.44%)  1
Pustular psoriasis * 1  1/229 (0.44%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Certolizumab Pegol 400 mg
Affected / at Risk (%) # Events
Total   190/229 (82.97%)    
Gastrointestinal disorders   
Abdominal pain * 1  45/229 (19.65%)  63
Abdominal pain upper * 1  18/229 (7.86%)  23
Anal fissure * 1  14/229 (6.11%)  16
Constipation * 1  14/229 (6.11%)  20
Crohn's disease * 1  41/229 (17.90%)  48
Diarrhoea * 1  33/229 (14.41%)  44
Haematochezia * 1  14/229 (6.11%)  16
Nausea * 1  23/229 (10.04%)  43
Vomiting * 1  24/229 (10.48%)  34
General disorders   
Asthenia * 1  12/229 (5.24%)  15
Fatigue * 1  21/229 (9.17%)  29
Pyrexia * 1  47/229 (20.52%)  93
Infections and infestations   
Bronchitis * 1  23/229 (10.04%)  33
Gastroenteritis * 1  16/229 (6.99%)  20
Herpes simplex * 1  24/229 (10.48%)  39
Influenza * 1  30/229 (13.10%)  35
Nasopharyngitis * 1  63/229 (27.51%)  117
Sinusitis * 1  23/229 (10.04%)  30
Upper respiratory tract infection * 1  12/229 (5.24%)  15
Urinary tract infection * 1  19/229 (8.30%)  31
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  44/229 (19.21%)  68
Back pain * 1  27/229 (11.79%)  31
Muscle spasms * 1  12/229 (5.24%)  16
Pain in extremity * 1  12/229 (5.24%)  19
Nervous system disorders   
Headache * 1  47/229 (20.52%)  80
Respiratory, thoracic and mediastinal disorders   
Cough * 1  28/229 (12.23%)  31
Pharyngolaryngeal pain * 1  21/229 (9.17%)  27
Skin and subcutaneous tissue disorders   
Rash * 1  20/229 (8.73%)  37
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
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 is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB Clinical Trial Call Center
Organization: UCB, Inc
Phone: +1 877 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00333788    
Other Study ID Numbers: C87046
2006-001729-24 ( EudraCT Number )
First Submitted: June 2, 2006
First Posted: June 6, 2006
Results First Submitted: April 13, 2011
Results First Posted: July 12, 2011
Last Update Posted: August 7, 2018