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 in subjects with active Crohn's Disease (CD) who were non-responders in the induction study (Study C87037), but who responded to a second induction with certolizumab pegol. Subjects underwent re-induction with certolizumab pegol 400 mg administered every 2 weeks for 3 doses; subjects who responded to the second induction received certolizumab pegol 400 mg administered every 4 weeks for 5 doses.
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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 14 (Week 6 in Study C87048) after re-induction.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects who gave written informed consent and who did not show clinical efficacy at Week 6 of the double-blind main study (2014-004399-42) [reduction in Crohn's Disease Activity Index (CDAI) score of ≥100 points from Week 0, or remission (CDAI ≤150)]
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E.4 | Principal exclusion criteria |
Subjects who experienced aggravation of Crohn's Disease during the double-blind main study (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 34
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (2014-004399-42)). 'Week 34' is 26 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, 10, 12, 14, 16, 20, 24, 28, 32, 34 and at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)
- Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 8, 10, 12, 14, 16, 20, 24, 28, 32 and at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)
- Percentage of Subjects Achieving Remission at Week 8, 10, 12, 14, 16, 20, 24, 28, 32, 34, and at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)
- Time to Disease Progression from Week 14 to Week 34
- Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 8, 10, 12, 14, 16, 20, 24, 28, 32, 34 and at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)
- Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 8, 10, 12, 14, 16, 20, 24, 28, 32, 34 and at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)
- Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 8, 10, 12, 14, 16, 20, 24, 28, 32, 34 and at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)
- Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 8, 10, 12, 14, 16, 20, 24, 28, 32, 34 and at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)
- Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 8, 10, 12, 14, 16, 20, 24, 28, 32, 34 and at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)
- C-Reactive Protein (CRP) Level at Week 0, 8, 10, 12, 14, 16, 20, 24, 28, 32, 34 and at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)
- Ratio of C-Reactive Protein (CRP) Level at Week 8, 10, 12, 14, 16, 20, 24, 28, 32, 34 and at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) to CRP Level at Week 0
- Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 8, 10, 12, 14, 16, 20, 24, 28, 32, 34 and at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) |
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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 8 ( First visit in this extension study)
- Week 10 (2 weeks after the first visit in this extension study)
- Week 12 (4 weeks after the first visit in this extension study)
- Week 14 (6 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 28 (20 weeks after the first visit in this extension study)
- Week 32 (24 weeks after the first visit in this extension study)
- Week 34 (26 weeks after the first visit in this extension study)
- Withdrawal Visit |
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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 | 2 |