Phase 2
Completed N=46
Maintenance Study Including Re-induction Therapy for Patients Who Did Not Show a Clinical Effect in Study C87037 (NCT00291668)
Source: ClinicalTrials.gov NCT00329420 ↗Enrolled (actual)
46
Serious AEs
17.4%
Results posted
Nov 2009
Primary outcomePrimary: Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 34 — 66.7; 28.6; 42.9; 33.3 Percentage of subjects
Summary
This 26-week extension study evaluates the efficacy and safety of certolizumab pegol administered subcutaneously every 4 weeks (dosed at Weeks 16, 20, 24, 28 and 32) in subjects with active Crohn's disease who had no clinical response at Week 6 to induction therapy in the 6-week double-blind main study, C87037 (NCT00291668), but subsequently showed clinical response at Week 14 to repeated induction therapy (dosed at Weeks 8, 10 and 12) in this extension study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 34 |
66.7; 28.6; 42.9; 33.3; 71.4; 57.1 | — |
| SECONDARY Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 8 |
-20.5; -53.1; -63.8 | — |
| SECONDARY Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 10 |
-96.1; -100.3; -90.0 | — |
| SECONDARY Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 12 |
-101.3; -100.5; -109.9 | — |
| SECONDARY Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 14 |
-124.3; -131.7; -147.0 | — |
| SECONDARY Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 16 |
-121.0; -70.4; -136.2 | — |
| SECONDARY Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 20 |
-105.3; -79.6; -130.9 | — |
| SECONDARY Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 24 |
-89.8; -70.6; -150.2 | — |
| SECONDARY Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 28 |
-118.2; -67.3; -154.8 | — |
| SECONDARY Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 32 |
-89.0; -77.3; -128.3 | — |
| SECONDARY Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 34 |
-134.9; -97.4; -132.7 | — |
| SECONDARY Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) |
-112.0; -61.0; -132.7 | — |
| SECONDARY Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 8 |
8.3; 14.3; 14.3; 91.7; 85.7; 85.7 | — |
| SECONDARY Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 10 |
41.7; 71.4; 42.9; 58.3; 28.6; 57.1 | — |
| SECONDARY Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 12 |
50.0; 71.4; 57.1; 50.0; 28.6; 42.9 | — |
| SECONDARY Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 14 |
100.0; 100.0; 100.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 16 |
66.7; 42.9; 85.7; 33.3; 57.1; 14.3 | — |
| SECONDARY Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 20 |
41.7; 28.6; 85.7; 58.3; 71.4; 14.3 | — |
| SECONDARY Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 24 |
41.7; 57.1; 71.4; 58.3; 42.9; 28.6 | — |
| SECONDARY Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 28 |
50.0; 28.6; 57.1; 50.0; 71.4; 42.9 | — |
| SECONDARY Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 32 |
33.3; 28.6; 57.1; 66.7; 71.4; 42.9 | — |
| SECONDARY Percentage of Crohn's Disease Activity Index (CDAI) Responders at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) |
66.7; 28.6; 42.9; 33.3; 71.4; 57.1 | — |
| SECONDARY Percentage of Subjects Achieving Remission at Week 8 |
0.0; 0.0; 14.3; 100.0; 100.0; 85.7 | — |
| SECONDARY Percentage of Subjects Achieving Remission at Week 10 |
33.3; 42.9; 14.3; 66.7; 57.1; 85.7 | — |
| SECONDARY Percentage of Subjects Achieving Remission at Week 12 |
25.0; 42.9; 42.9; 75.0; 57.1; 57.1 | — |
| SECONDARY Percentage of Subjects Achieving Remission at Week 14 |
66.7; 71.4; 71.4; 33.3; 28.6; 28.6 | — |
| SECONDARY Percentage of Subjects Achieving Remission at Week 16 |
33.3; 28.6; 57.1; 66.7; 71.4; 42.9 | — |
| SECONDARY Percentage of Subjects Achieving Remission at Week 20 |
33.3; 28.6; 57.1; 66.7; 71.4; 42.9 | — |
| SECONDARY Percentage of Subjects Achieving Remission at Week 24 |
16.7; 42.9; 71.4; 83.3; 57.1; 28.6 | — |
| SECONDARY Percentage of Subjects Achieving Remission at Week 28 |
25.0; 28.6; 57.1; 75.0; 71.4; 42.9 | — |
| SECONDARY Percentage of Subjects Achieving Remission at Week 32 |
16.7; 28.6; 42.9; 83.3; 71.4; 57.1 | — |
| SECONDARY Percentage of Subjects Achieving Remission at Week 34 |
33.3; 28.6; 42.9; 66.7; 71.4; 57.1 | — |
| SECONDARY Percentage of Subjects Achieving Remission at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) |
33.3; 28.6; 42.9; 66.7; 71.4; 57.1 | — |
| SECONDARY Time to Disease Progression |
— | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 8 |
4.6; 9.1; 5.3 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 10 |
17.0; 20.9; 15.1 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 12 |
17.3; 26.3; 20.1 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 14 |
20.1; 28.6; 26.3 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 16 |
16.3; 15.3; 20.0 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 20 |
12.2; 18.4; 15.9 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 24 |
8.3; 7.6; 18.4 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 28 |
14.9; 11.4; 15.9 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 32 |
11.3; 11.2; 25.3 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 34 |
21.6; 14.8; 20.6 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) |
15.6; 10.8; 20.6 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 8 |
1.9; 6.4; 2.4 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 10 |
6.2; 10.6; 5.9 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 12 |
5.7; 11.7; 7.4 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 14 |
6.9; 12.3; 9.3 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 16 |
5.2; 8.4; 6.3 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 20 |
3.5; 9.9; 5.1 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 24 |
0.7; 4.7; 5.6 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 28 |
4.6; 8.3; 5.4 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 32 |
3.1; 9.6; 7.5 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 34 |
7.1; 11.8; 5.8 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) |
5.5; 8.3; 5.8 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 8 |
1.4; 0.6; 1.7 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 10 |
4.6; 3.7; 3.9 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 12 |
5.7; 5.0; 5.1 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 14 |
5.9; 6.4; 6.3 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 16 |
5.5; 3.9; 5.3 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 20 |
3.6; 3.6; 3.6 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 24 |
3.1; 2.1; 4.1 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 28 |
3.0; 3.0; 4.4 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 32 |
3.4; 0.4; 6.8 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 34 |
5.0; 3.0; 5.4 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) |
4.2; 3.2; 5.4 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 8 |
-0.3; 2.1; 0.4 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 10 |
3.3; 4.4; 4.3 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 12 |
2.5; 7.0; 5.3 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 14 |
3.8; 7.1; 6.7 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 16 |
2.5; 3.0; 6.0 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 20 |
1.9; 3.4; 3.6 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 24 |
2.1; 1.6; 6.1 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 28 |
4.3; 1.1; 3.6 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 32 |
2.9; 1.8; 7.7 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 34 |
5.6; 0.0; 6.4 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) |
3.5; 0.7; 6.4 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 8 |
1.3; 0.0; 0.7 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 10 |
2.5; 2.1; 1.1 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 12 |
3.0; 2.6; 2.3 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 14 |
2.8; 2.7; 4.0 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 16 |
2.5; 0.0; 2.4 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 20 |
2.8; 1.6; 3.6 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 24 |
1.8; -0.9; 2.6 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 28 |
2.1; -1.0; 2.4 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 32 |
1.3; -0.6; 3.3 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 34 |
3.0; 0.0; 3.0 | — |
| SECONDARY Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) |
1.7; -1.3; 3.0 | — |
| SECONDARY C-Reactive Protein (CRP) Level at Week 0 |
19.58; 14.97; 26.45 | — |
| SECONDARY C-Reactive Protein (CRP) Level at Week 8 |
22.06; 11.91; 16.70 | — |
| SECONDARY C-Reactive Protein (CRP) Level at Week 10 |
7.76; 5.62; 12.01 | — |
| SECONDARY C-Reactive Protein (CRP) Level at Week 12 |
7.82; 7.06; 13.39 | — |
| SECONDARY C-Reactive Protein (CRP) Level at Week 14 |
9.57; 6.32; 15.30 | — |
| SECONDARY C-Reactive Protein (CRP) Level at Week 16 |
12.54; 12.23; 15.10 | — |
| SECONDARY C-Reactive Protein (CRP) Level at Week 20 |
12.27; 13.24; 14.99 | — |
| SECONDARY C-Reactive Protein (CRP) Level at Week 24 |
9.11; 14.16; 15.70 | — |
| SECONDARY C-Reactive Protein (CRP) Level at Week 28 |
8.79; 14.25; 26.81 | — |
| SECONDARY C-Reactive Protein (CRP) Level at Week 32 |
15.28; 10.27; 16.71 | — |
| SECONDARY C-Reactive Protein (CRP) Level at Week 34 |
9.19; 6.23; 23.52 | — |
| SECONDARY C-Reactive Protein (CRP) Level at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) |
11.25; 8.46; 23.52 | — |
| SECONDARY Ratio of C-Reactive Protein (CRP) Level at Week 8 to CRP Level at Week 0 |
1.13; 0.80; 0.63 | — |
| SECONDARY Ratio of C-Reactive Protein (CRP) Level at Week 10 to CRP Level at Week 0 |
0.4; 0.38; 0.45 | — |
| SECONDARY Ratio of C-Reactive Protein (CRP) Level at Week 12 to CRP Level at Week 0 |
0.4; 0.47; 0.51 | — |
| SECONDARY Ratio of C-Reactive Protein (CRP) Level at Week 14 to CRP Level at Week 0 |
0.49; 0.42; 0.58 | — |
| SECONDARY Ratio of C-Reactive Protein (CRP) Level at Week 16 to CRP Level at Week 0 |
0.64; 0.82; 0.57 | — |
| SECONDARY Ratio of C-Reactive Protein (CRP) Level at Week 20 to CRP Level at Week 0 |
0.64; 0.88; 0.57 | — |
| SECONDARY Ratio of C-Reactive Protein (CRP) Level at Week 24 to CRP Level at Week 0 |
0.48; 0.95; 0.59 | — |
| SECONDARY Ratio of C-Reactive Protein (CRP) Level at Week 28 to CRP Level at Week 0 |
0.46; 0.95; 1.06 | — |
| SECONDARY Ratio of C-Reactive Protein (CRP) Level at Week 32 to CRP Level at Week 0 |
0.90; 0.64; 0.62 | — |
| SECONDARY Ratio of C-Reactive Protein (CRP) Level at Week 34 to CRP Level at Week 0 |
0.54; 0.39; 1.07 | — |
| SECONDARY Ratio of C-Reactive Protein (CRP) Level at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) to CRP Level at Week 0 |
0.59; 0.54; 1.07 | — |
| SECONDARY Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 8 |
33.3; 28.6; 42.9; 66.7; 71.4; 57.1 | — |
| SECONDARY Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 10 |
66.7; 85.7; 100.0; 33.3; 14.3; 0.0 | — |
| SECONDARY Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 12 |
75.0; 71.4; 85.7; 25.0; 28.6; 14.3 | — |
| SECONDARY Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 14 |
100.0; 100.0; 100.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 16 |
83.3; 57.1; 100.0; 16.7; 42.9; 0.0 | — |
| SECONDARY Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 20 |
75.0; 71.4; 85.7; 25.0; 28.6; 14.3 | — |
| SECONDARY Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 24 |
50.0; 71.4; 100.0; 50.0; 28.6; 0.0 | — |
| SECONDARY Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 28 |
58.3; 71.4; 85.7; 41.7; 28.6; 14.3 | — |
| SECONDARY Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 32 |
41.7; 57.1; 57.1; 58.3; 42.9; 42.9 | — |
| SECONDARY Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 34 |
66.7; 42.9; 42.9; 33.3; 57.1; 57.1 | — |
| SECONDARY Percentage of Subjects Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) |
66.7; 42.9; 42.9; 33.3; 57.1; 57.1 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who gave written informed consent and who did not show clinical efficacy at Week 6 of the double-blind main study (NCT00291668) [reduction in Crohn's Disease Activity Index (CDAI) score of ≥100 points from Week 0, or remission (CDAI ≤150)]
Exclusion Criteria
- Subjects who experienced aggravation of Crohn's Disease during the double-blind main study (NCT00291668) and required treatment change
Data sourced from ClinicalTrials.gov (NCT00329420). 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.