Phase 2
Completed N=40
Maintenance Study of Certolizumab Pegol (CZP) in Crohn's Disease
Source: ClinicalTrials.gov NCT00329550 ↗Enrolled (actual)
40
Serious AEs
30.8%
Results posted
Nov 2009
Primary outcomePrimary: Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 26 — 44.4; 73.3; 60.0; 55.6 Percentage of subjects
Summary
This is a multi-centre, open-label extension study in subjects who showed clinical response to induction therapy in the treatment of subjects with active Crohn's disease in the double-blind main study C87037 (NCT00291668).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 26 |
44.4; 73.3; 60.0; 55.6; 26.7; 40.0 | — |
| SECONDARY Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 8 |
-126.7; -124.9; -141.8 | — |
| SECONDARY Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 12 |
-152.6; -145.4; -152.8 | — |
| SECONDARY Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 16 |
-162.8; -142.2; -143.3 | — |
| SECONDARY Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 20 |
-147.0; -149.4; -130.7 | — |
| SECONDARY Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 24 |
-158.6; -153.3; -138.9 | — |
| SECONDARY Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 26 |
-131.1; -173.8; -153.1 | — |
| SECONDARY 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] |
-132.7; -143.2; -152.5 | — |
| SECONDARY Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 8 |
55.6; 66.7; 80.0; 44.4; 33.3; 20.0 | — |
| SECONDARY Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 12 |
77.8; 73.3; 86.7; 22.2; 26.7; 13.3 | — |
| SECONDARY Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 16 |
77.8; 60.0; 66.7; 22.2; 40.0; 33.3 | — |
| SECONDARY Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 20 |
66.7; 60.0; 60.0; 33.3; 40.0; 40.0 | — |
| SECONDARY Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 24 |
44.4; 60.0; 53.3; 55.6; 40.0; 46.7 | — |
| SECONDARY Percentage of Crohn's Disease Activity Index (CDAI) Responders at Last Visit [Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals] |
44.4; 73.3; 60.0; 55.6; 26.7; 40.0 | — |
| SECONDARY Percentage of Subjects Achieving Remission at Week 8 |
33.3; 40.0; 53.3; 66.7; 60.0; 46.7 | — |
| SECONDARY Percentage of Subjects Achieving Remission at Week 12 |
44.4; 46.7; 53.3; 55.6; 53.3; 46.7 | — |
| SECONDARY Percentage of Subjects Achieving Remission at Week 16 |
44.4; 46.7; 40.0; 55.6; 53.3; 60.0 | — |
| SECONDARY Percentage of Subjects Achieving Remission at Week 20 |
22.2; 53.3; 40.0; 77.8; 46.7; 60.0 | — |
| SECONDARY Percentage of Subjects Achieving Remission at Week 24 |
22.2; 46.7; 40.0; 77.8; 53.3; 60.0 | — |
| SECONDARY Percentage of Subjects Achieving Remission at Week 26 |
22.2; 46.7; 46.7; 77.8; 53.3; 53.3 | — |
| SECONDARY Percentage of Subjects Achieving Remission at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) |
22.2; 46.7; 46.7; 77.8; 53.3; 53.3 | — |
| SECONDARY Time to Disease Progression |
— | — |
| SECONDARY Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score |
33.8; 30.4; 23.7 | — |
| SECONDARY Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score |
37.6; 29.9; 25.5 | — |
| SECONDARY Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score |
31.0; 30.1; 22.6 | — |
| SECONDARY Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score |
32.2; 31.6; 19.2 | — |
| SECONDARY Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score |
34.0; 32.7; 23.6 | — |
| SECONDARY Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score |
33.4; 38.4; 28.2 | — |
| SECONDARY 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 |
28.0; 33.3; 26.1 | — |
| SECONDARY Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score |
10.7; 10.3; 9.5 | — |
| SECONDARY Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score |
12.6; 10.2; 9.8 | — |
| SECONDARY Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score |
9.9; 8.8; 6.7 | — |
| SECONDARY Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score |
9.5; 11.3; 6.7 | — |
| SECONDARY Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score |
11.0; 10.4; 8.0 | — |
| SECONDARY Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score |
11.6; 12.0; 8.8 | — |
| SECONDARY 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 |
9.6; 10.7; 8.1 | — |
| SECONDARY Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score |
7.6; 7.1; 5.7 | — |
| SECONDARY Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score |
7.4; 7.4; 5.9 | — |
| SECONDARY Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score |
6.8; 7.9; 5.9 | — |
| SECONDARY Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score |
7.5; 7.3; 4.9 | — |
| SECONDARY Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score |
8.2; 7.5; 6.2 | — |
| SECONDARY Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score |
6.4; 8.7; 7.2 | — |
| SECONDARY 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 |
5.1; 8.8; 7.2 | — |
| SECONDARY Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score |
9.4; 7.5; 5.1 | — |
| SECONDARY Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score |
10.8; 7.7; 5.4 | — |
| SECONDARY Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score |
8.0; 7.8; 6.1 | — |
| SECONDARY Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score |
8.5; 6.8; 4.1 | — |
| SECONDARY Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score |
8.3; 8.6; 6.2 | — |
| SECONDARY Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score |
9.4; 11.3; 6.8 | — |
| SECONDARY 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 |
7.4; 9.0; 5.8 | — |
| SECONDARY Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score |
6.1; 5.5; 3.5 | — |
| SECONDARY Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score |
6.9; 4.5; 4.5 | — |
| SECONDARY Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score |
6.4; 5.6; 4.0 | — |
| SECONDARY Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score |
6.7; 6.1; 3.6 | — |
| SECONDARY Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score |
6.5; 6.2; 3.3 | — |
| SECONDARY Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score |
6.0; 6.4; 5.7 | — |
| SECONDARY 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 |
5.9; 4.8; 5.2 | — |
| SECONDARY C-Reactive Protein (CRP) Level at Week 0 |
21.37; 26.31; 25.88 | — |
| SECONDARY C-Reactive Protein (CRP) Level at Week 8 |
23.80; 19.11; 11.61 | — |
| SECONDARY C-Reactive Protein (CRP) Level at Week 12 |
12.55; 14.91; 11.64 | — |
| SECONDARY C-Reactive Protein (CRP) Level at Week 16 |
16.12; 16.06; 14.05 | — |
| SECONDARY C-Reactive Protein (CRP) Level at Week 20 |
17.16; 13.16; 17.44 | — |
| SECONDARY C-Reactive Protein (CRP) Level at Week 24 |
10.97; 12.44; 16.84 | — |
| SECONDARY C-Reactive Protein (CRP) Level at Week 26 |
15.94; 9.96; 13.11 | — |
| SECONDARY C-Reactive Protein (CRP) Level at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) |
19.81; 13.12; 14.04 | — |
| SECONDARY Ratio of C-Reactive Protein (CRP) Level at Week 8 to Week 0 |
1.11; 0.73; 0.45 | — |
| SECONDARY Ratio of C-Reactive Protein (CRP) Level at Week 12 to Week 0 |
0.63; 0.55; 0.45 | — |
| SECONDARY Ratio of C-Reactive Protein (CRP) Level at Week 16 to Week 0 |
0.81; 0.59; 0.53 | — |
| SECONDARY Ratio of C-Reactive Protein (CRP) Level at Week 20 to Week 0 |
0.65; 0.53; 0.66 | — |
| SECONDARY Ratio of C-Reactive Protein (CRP) Level at Week 24 to Week 0 |
0.72; 0.5; 0.62 | — |
| SECONDARY Ratio of C-Reactive Protein (CRP) Level at Week 26 to Week 0 |
0.63; 0.4; 0.47 | — |
| SECONDARY Ratio of C-Reactive Protein (CRP) Level at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) to Week 0 |
0.72; 0.48; 0.52 | — |
| SECONDARY Percentage of Subjects at Week 8 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 |
77.8; 73.3; 86.7; 22.2; 26.7; 13.3 | — |
| SECONDARY Percentage of Subjects at Week 12 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 |
77.8; 80.0; 93.3; 22.2; 20.0; 6.7 | — |
| SECONDARY Percentage of Subjects at Week 16 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 |
77.8; 66.7; 66.7; 22.2; 33.3; 33.3 | — |
| SECONDARY Percentage of Subjects at Week 20 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 |
66.7; 60.0; 73.3; 33.3; 40.0; 26.7 | — |
| SECONDARY Percentage of Subjects at Week 24 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 |
55.6; 66.7; 60.0; 44.4; 33.3; 40.0 | — |
| SECONDARY Percentage of Subjects at Week 26 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 |
55.6; 73.3; 73.3; 44.4; 26.7; 26.7 | — |
| SECONDARY 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 |
55.6; 73.3; 73.3; 44.4; 26.7; 26.7 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who participated in main double-blind induction study C87037 (NCT00291668) and showed clinical efficacy
Exclusion Criteria
- Subjects who experienced aggravation of Crohn's disease during main double-blind induction study C87037 (NCT00291668) and required treatment change
Data sourced from ClinicalTrials.gov (NCT00329550). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.