Clinical Trial Results:
A Phase II, multi-center, double-blind, placebo-controlled, parallel-group, dose-response study to assess the safety and efficacy of CDP870/Certolizumab pegol, dosed subcutaneously in patients with active crohn's disease
Summary
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EudraCT number |
2014-004399-42 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
08 Nov 2007
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Results information
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Results version number |
v2(current) |
This version publication date |
24 Sep 2020
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First version publication date |
11 Jun 2015
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Other versions |
v1 |
Version creation reason |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
C87037
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00291668 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
UCB Japan Co., Ltd
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Sponsor organisation address |
Shinjuku-ku, Tokyo, Japan, 160-0023
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Public contact |
Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, +49 2173 4815 15, clinicaltrials@ucb.com
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Scientific contact |
Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, +49 2173 48 15 15, clinicaltrials@ucb.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
26 Aug 2008
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
08 Nov 2007
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective of the study was to estimate the dose response in subjects with active Crohn’s Disease (CD), and to evaluate the efficacy of certolizumab pegol in these subjects.
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Protection of trial subjects |
Not applicable
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Background therapy |
Steroids, immunosuppressants, antibacterial agents, 5-ASA derivatives, antidiarrheal drugs, topical ano-rectal treatments, and laxative drugs/enemas were allowed concomitantly with no change in dosage and administration from the start of the observation period to Week 6. | ||
Evidence for comparator |
Not applicable | ||
Actual start date of recruitment |
02 Mar 2006
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Safety | ||
Long term follow-up duration |
9 Months | ||
Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Japan: 94
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Worldwide total number of subjects |
94
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
6
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Adults (18-64 years) |
88
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
This study started to enroll subjects in March 2006 and concluded in November 2007. | ||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
Participant Flow refers to the Safety Set, including all randomized subjects who received at least one dose of study medication (Placebo or Certolizumab Pegol). | ||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator, Carer | ||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Placebo | ||||||||||||||||||||||||||||||||
Arm description |
Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4. | ||||||||||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
PBO
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4.
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Arm title
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Certolizumab pegol 200 mg | ||||||||||||||||||||||||||||||||
Arm description |
Subjects received one subcutaneous (sc) injection of 200 mg CZP and one injection of Placebo to maintain the study blind on Weeks 0 (first dose), 2 and 4. | ||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Certolizumab Pegol
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Investigational medicinal product code |
CZP
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Other name |
Cimzia
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Subjects in the CZP 200 mg arm received one subcutaneous (sc) injection of 200 mg CZP and one injection of Placebo to maintain the study blind on Weeks 0 (first dose), 2 and 4.
Subjects in the CZP 400 mg arm received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4.
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Arm title
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Certolizumab pegol 400 mg | ||||||||||||||||||||||||||||||||
Arm description |
Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4. | ||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Certolizumab Pegol
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Investigational medicinal product code |
CZP
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Other name |
Cimzia
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Subjects in the CZP 200 mg arm received one subcutaneous (sc) injection of 200 mg CZP and one injection of Placebo to maintain the study blind on Weeks 0 (first dose), 2 and 4.
Subjects in the CZP 400 mg arm received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4.
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Baseline characteristics reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Certolizumab pegol 200 mg
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Reporting group description |
Subjects received one subcutaneous (sc) injection of 200 mg CZP and one injection of Placebo to maintain the study blind on Weeks 0 (first dose), 2 and 4. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Certolizumab pegol 400 mg
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Reporting group description |
Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4. | ||
Reporting group title |
Certolizumab pegol 200 mg
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Reporting group description |
Subjects received one subcutaneous (sc) injection of 200 mg CZP and one injection of Placebo to maintain the study blind on Weeks 0 (first dose), 2 and 4. | ||
Reporting group title |
Certolizumab pegol 400 mg
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Reporting group description |
Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4. | ||
Subject analysis set title |
Full Analysis Set (Placebo treated subjects)
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:
- Subjects with Good Clinical Practice (GCP) violations
- Subjects who were not diagnosed (definitely) with Crohn’s Disease
- Subjects who received no dose of study medication
- Subjects with no data after randomization
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Subject analysis set title |
Full Analysis Set (CZP 200 mg treated subjects)
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:
- Subjects with Good Clinical Practice (GCP) violations
- Subjects who were not diagnosed (definitely) with Crohn’s Disease
- Subjects who received no dose of study medication
- Subjects with no data after randomization
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Subject analysis set title |
Full Analysis Set (CZP 400 mg treated subjects)
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding:
- Subjects with Good Clinical Practice (GCP) violations
- Subjects who were not diagnosed (definitely) with Crohn’s Disease
- Subjects who received no dose of study medication
- Subjects with no data after randomization
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End point title |
Crohn’s Disease Activity Index (CDAI) response (clinical response or remission) at Week 6 [1] | ||||||||||||||||||||
End point description |
CDAI Response is presented as the percentage of subjects with clinical response at Week 6 or remission at Week 6. Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 6) – (CDAI score at Week 0). Remission is defined as a CDAI of <= 150 at Week 6.
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End point type |
Primary
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End point timeframe |
Baseline, Week 6
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
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No statistical analyses for this end point |
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End point title |
Crohn’s Disease Activity Index (CDAI) score at Week 2 | ||||||||||||||||||||
End point description |
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. The CDAI score can range from 0-600 (600 indicating the worst disease). It is the sum of 8 subscores, only the summary score is used here. A CDAI score of 150 or less is considered as remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
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End point type |
Secondary
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End point timeframe |
Week 2
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No statistical analyses for this end point |
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End point title |
Crohn’s Disease Activity Index (CDAI) score at Week 4 | ||||||||||||||||||||
End point description |
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. The CDAI score can range from 0-600 (600 indicating the worst disease). It is the sum of 8 subscores, only the summary score is used here. A CDAI score of 150 or less is considered as remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
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End point type |
Secondary
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End point timeframe |
Week 4
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No statistical analyses for this end point |
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End point title |
Crohn’s Disease Activity Index (CDAI) score at Week 6 | ||||||||||||||||||||
End point description |
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. The CDAI score can range from 0-600 (600 indicating the worst disease). It is the sum of 8 subscores, only the summary score is used here. A CDAI score of 150 or less is considered as remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
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End point type |
Secondary
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End point timeframe |
Week 6
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No statistical analyses for this end point |
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End point title |
Percentage of subjects who achieve CDAI response at Week 2 | ||||||||||||||||||||
End point description |
CDAI Response at Week 2 is defined as clinical response at Week 2 or remission at Week 2. Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 2) – (CDAI score at Week 0). Remission is defined as a CDAI score of ≤ 150 points.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 2
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No statistical analyses for this end point |
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End point title |
Percentage of subjects who achieve CDAI response at Week 4 | ||||||||||||||||||||
End point description |
CDAI Response at Week 4 is defined as clinical response at Week 4 or remission at Week 4. Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 4) – (CDAI score at Week 0). Remission is defined as a CDAI score of ≤ 150 points.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 4
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No statistical analyses for this end point |
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End point title |
Percentage of subjects who achieve a reduction in CDAI scores of at least 70 points at Week 2 | ||||||||||||||||||||
End point description |
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 2
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No statistical analyses for this end point |
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End point title |
Percentage of subjects who achieve a reduction in CDAI scores of at least 70 points at Week 4 | ||||||||||||||||||||
End point description |
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 4
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No statistical analyses for this end point |
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End point title |
Percentage of subjects who achieve a reduction in CDAI scores of at least 70 points at Week 6 | ||||||||||||||||||||
End point description |
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 6
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No statistical analyses for this end point |
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End point title |
Percentage of subjects who achieve remission (CDAI <= 150) at Week 2 | ||||||||||||||||||||
End point description |
Remission at Week 2 is defined as a CDAI score <= 150 points at Week 2.
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End point type |
Secondary
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End point timeframe |
Week 2
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No statistical analyses for this end point |
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End point title |
Percentage of subjects who achieve remission (CDAI <= 150) at Week 4 | ||||||||||||||||||||
End point description |
Remission at Week 4 is defined as a CDAI score <= 150 points at Week 4.
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End point type |
Secondary
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End point timeframe |
Week 4
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No statistical analyses for this end point |
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End point title |
Percentage of subjects who achieve remission (CDAI <= 150) at Week 6 | ||||||||||||||||||||
End point description |
Remission at Week 6 is defined as a CDAI score <= 150 points at Week 6.
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End point type |
Secondary
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End point timeframe |
Week 6
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No statistical analyses for this end point |
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End point title |
Percentage of subjects who achieve clinical response (reduction in CDAI scores of at least 100 points) at Week 2 | ||||||||||||||||||||
End point description |
Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 2) – (CDAI score at Week 0).
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End point type |
Secondary
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End point timeframe |
Baseline, Week 2
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No statistical analyses for this end point |
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End point title |
Percentage of subjects who achieve clinical response (reduction in CDAI scores of at least 100 points) at Week 4 | ||||||||||||||||||||
End point description |
Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 4) – (CDAI score at Week 0).
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End point type |
Secondary
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End point timeframe |
Baseline, Week 4
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No statistical analyses for this end point |
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End point title |
Percentage of subjects who achieve clinical response (reduction in CDAI scores of at least 100 points) at Week 6 | ||||||||||||||||||||
End point description |
Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 6) – (CDAI score at Week 0).
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End point type |
Secondary
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End point timeframe |
Baseline, Week 6
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No statistical analyses for this end point |
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End point title |
Inflammatory Bowel Disease Questionnaire (IBDQ) global score at Week 2 | ||||||||||||||||||||
End point description |
The IBDQ global score is calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life.
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End point type |
Secondary
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End point timeframe |
Week 2
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No statistical analyses for this end point |
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End point title |
Inflammatory Bowel Disease Questionnaire (IBDQ) global score at Week 4 | ||||||||||||||||||||
End point description |
The IBDQ global score is calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life.
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End point type |
Secondary
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End point timeframe |
Week 4
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No statistical analyses for this end point |
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End point title |
Inflammatory Bowel Disease Questionnaire (IBDQ) global score at Week 6 | ||||||||||||||||||||
End point description |
The IBDQ global score is calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life.
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End point type |
Secondary
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End point timeframe |
Week 6
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No statistical analyses for this end point |
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End point title |
Inflammatory Bowel Disease Questionnaire (IBDQ) domain scores at Week 2 | ||||||||||||||||||||||||||||||||
End point description |
The total IBDQ score consists of 32 questions, each ranging from 1 to 7, with higher scores indicating a better quality of life.
There are 4 IBDQ Domain Scores:
- Bowel Symptoms Domain Score, ranging from 10 to 70 (10 questions ranging from 1 to 7)
- Systemic Symptoms Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )
- Emotional Function Domain Score, ranging from 12 to 84 (12 questions ranging from 1 to 7)
- Social Function Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )
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End point type |
Secondary
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End point timeframe |
Week 2
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No statistical analyses for this end point |
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End point title |
Inflammatory Bowel Disease Questionnaire (IBDQ) domain scores at Week 4 | ||||||||||||||||||||||||||||||||
End point description |
The total IBDQ score consists of 32 questions, each ranging from 1 to 7, with higher scores indicating a better quality of life.
There are 4 IBDQ Domain Scores:
- Bowel Symptoms Domain Score, ranging from 10 to 70 (10 questions ranging from 1 to 7)
- Systemic Symptoms Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )
- Emotional Function Domain Score, ranging from 12 to 84 (12 questions ranging from 1 to 7)
- Social Function Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )
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End point type |
Secondary
|
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End point timeframe |
Week 4
|
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No statistical analyses for this end point |
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End point title |
Inflammatory Bowel Disease Questionnaire (IBDQ) domain scores at Week 6 | ||||||||||||||||||||||||||||||||
End point description |
The total IBDQ score consists of 32 questions, each ranging from 1 to 7, with higher scores indicating a better quality of life.
There are 4 IBDQ Domain Scores:
- Bowel Symptoms Domain Score, ranging from 10 to 70 (10 questions ranging from 1 to 7)
- Systemic Symptoms Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )
- Emotional Function Domain Score, ranging from 12 to 84 (12 questions ranging from 1 to 7)
- Social Function Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )
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End point type |
Secondary
|
||||||||||||||||||||||||||||||||
End point timeframe |
Week 6
|
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No statistical analyses for this end point |
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End point title |
Concentration of C-reactive Protein (CRP) Value at Week 2 | ||||||||||||||||||||
End point description |
CRP data for subjects receiving rescue medication were excluded.
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End point type |
Secondary
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||||||||||||||||||||
End point timeframe |
Week 2
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No statistical analyses for this end point |
|
|||||||||||||||||||||
End point title |
Concentration of C-reactive Protein (CRP) Value at Week 4 | ||||||||||||||||||||
End point description |
CRP data for subjects receiving rescue medication were excluded.
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Week 4
|
||||||||||||||||||||
|
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
End point title |
Concentration of C-reactive Protein (CRP) Value at Week 6 | ||||||||||||||||||||
End point description |
CRP data for subjects receiving rescue medication were excluded.
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Week 6
|
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|
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
End point title |
C-reactive protein (CRP) Ratio to Baseline at Week 2 | ||||||||||||||||||||
End point description |
CRP data for subjects receiving rescue medication were excluded.
|
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End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Baseline, Week 2
|
||||||||||||||||||||
|
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
End point title |
C-reactive protein (CRP) Ratio to Baseline at Week 4 | ||||||||||||||||||||
End point description |
CRP data for subjects receiving rescue medication were excluded.
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Baseline, Week 4
|
||||||||||||||||||||
|
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
End point title |
C-reactive protein (CRP) Ratio to Baseline at Week 6 | ||||||||||||||||||||
End point description |
CRP data for subjects receiving rescue medication were excluded.
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Baseline, Week 6
|
||||||||||||||||||||
|
|||||||||||||||||||||
No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Adverse Events were collected from the time of signing the informed consent through the last Observation (up to 28 weeks).
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Adverse event reporting additional description |
Adverse Events refer to the Safety Population, including all randomized subjects who received at least one dose of study medication (Placebo or Certolizumab Pegol).
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
9.0
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Reporting groups
|
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Reporting group title |
Placebo
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Reporting group description |
Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Certolizumab pegol 400 mg
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Reporting group description |
Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Certolizumab pegol 200 mg
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Reporting group description |
Subjects received one subcutaneous (sc) injection of 200 mg CZP and one injection of Placebo to maintain the study blind on Weeks 0 (first dose), 2 and 4. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |