E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10011401 |
E.1.2 | Term | Crohn's disease |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of the study was to evaluate the efficacy of certolizumab pegol 400 mg administered subcutaneously (sc) at 4-week intervals from Week 8 to Week 24 in active Crohn’s Disease (CD) subjects showing clinical efficacy at Week 6 of the induction study (Study C87037 [2014-004399-42]).
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E.2.2 | Secondary objectives of the trial |
Secondary objectives were to evaluate the safety of certolizumab pegol 400 mg over the treatment period and to assess the time to disease progression in subjects showing clinical efficacy at Week 6 in Study C87037 [2014-004399-42].
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects who participated in main double-blind induction study C87037 [2014-004399-42] and showed clinical efficacy
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E.4 | Principal exclusion criteria |
Subjects who experienced aggravation of Crohn’s disease during main double-blind induction study C87037 [2014-004399-42] and required treatment change
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 26
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (2014-004399-42)). 'Week 26' is 18 weeks after the first visit in this extension study.
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E.5.2 | Secondary end point(s) |
- Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 8, 12, 16, 20, 24, 26 and Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals)
- Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 8, 12, 16, 20, 24 and Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals)
- Percentage of Subjects Achieving Remission at Week 8, 12, 16, 20, 24, 26 and Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals)
- Time to Disease Progression
- Change From Week 0 to Week 8, 12, 16, 20, 24, 26 and to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score
- Change From Week 0 to Week 8, 12, 16, 20, 24, 26 and to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score
- Change From Week 0 to Week 8, 12, 16, 20, 24, 26 and to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score
- Change From Week 0 to Week 8, 12, 16, 20, 24, 26 and to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score
- Change From Week 0 to Week 8, 12, 16, 20, 24, 26 and to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score
- C-Reactive Protein (CRP) Level at Week 0, 8, 12, 16, 20, 24, 26 and at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals)
- Ratio of C-Reactive Protein (CRP) Level at Week 8, 12, 16, 20, 24, 26 and at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) to Week 0
- Percentage of Subjects at Week 8, 12, 16, 20, 24, 26 and 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
- Number of Subjects With Disease Progression |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Week 0 (Baseline visit in the double-blind main study)
- Week 6 (last visit in the double-blind main study)
- Week 8 (first visit in this extension study)
- Week 12 (4 weeks after the first visit in this extension study)
- Week 16 (8 weeks after the first visit in this extension study)
- Week 20 (12 weeks after the first visit in this extension study)
- Week 24 (16 weeks after the first visit in this extension study)
- Week 26 (18 weeks after the first visit in this extension study)
- Last Visit (Week 26 for completers or the Withdrawal Visit for premature withdrawals) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 11 |