Phase 3
Completed N=177
Remission in Subjects With Crohn's Disease, Open Label Extension
Source: ClinicalTrials.gov NCT01070303 ↗Enrolled (actual)
177
Serious AEs
27.2%
Results posted
May 2010
Primary outcomePrimary: Number of Participants Achieving Clinical Remission (Crohn's Disease Activity Index[CDAI] <150 Points) at Week 104 of Study M02-433 (Starting From Week 0 of NCT00055497) (Through 1 Year of Participation in NCT01070303). — 29; 71 Participants
Summary
The objectives were: (1) To demonstrate the efficacy of adalimumab in the long-term maintenance of clinical remission in participants with Crohn's disease; and (2) To delineate the long-term safety of adalimumab when administered to participants with Crohn's disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Achieving Clinical Remission (Crohn's Disease Activity Index[CDAI] <150 Points) at Week 104 of Study M02-433 (Starting From Week 0 of NCT00055497) (Through 1 Year of Participation in NCT01070303). |
29; 71 | — |
| SECONDARY Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 152 (Through 2 Years of Participation in NCT01070303). |
26; 62 | — |
| SECONDARY Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 212 (Through 3 Years of Participation in NCT01070303). |
21; 45 | — |
| SECONDARY Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 260 (4 Years of Participation in NCT01070303). |
8; 21 | — |
| SECONDARY Number of Participants Achieving CR-100 at Week 104 (1 Year of Participation in NCT01070303) |
28; 87 | — |
| SECONDARY Number of Participants Achieving CR-100 at Week 152 (2 Years of Participation in NCT01070303) |
28; 74 | — |
| SECONDARY Number of Participants Achieving CR-100 at Week 212 (3 Years of Participation in NCT01070303) |
23; 58 | — |
| SECONDARY Number of Participants Achieving CR-100 at Week 260 (4 Years of Participation in NCT01070303) |
8; 27 | — |
| SECONDARY Number of Participants Achieving CR-70 at Week 104 (1 Year of Participation in NCT01070303) |
31; 92 | — |
| SECONDARY Number of Participants Achieving CR-70 at Week 152 (2 Years of Participation in NCT01070303) |
30; 77 | — |
| SECONDARY Number of Participants Achieving CR-70 at Week 212 (3 Years of Participation in NCT01070303) |
24; 63 | — |
| SECONDARY Number of Participants Achieving CR-70 at Week 260 (4 Years of Participation in NCT01070303) |
10; 27 | — |
| SECONDARY Number of Participants Achieving Steroid-free Clinical Remission at Week 104 (1 Year of Participation in NCT01070303) |
8; 12 | — |
| SECONDARY Number of Achieving Steroid-free Clinical Remission at Week 152 (2 Years of Participation in NCT01070303) |
8; 14 | — |
| SECONDARY Number of Participants Achieving Steroid-free Clinical Remission at Week 212 (3 Years of Participation in NCT01070303) |
5; 10 | — |
| SECONDARY Number of Participants Achieving Steroid-free Clinical Remission at Week 260 (4 Years of Participation in NCT01070303) |
2; 4 | — |
| SECONDARY Number of Participants Achieving Steroid-free CR-100 at Week 104 (1 Year of Participation in NCT01070303) |
9; 15 | — |
| SECONDARY Number of Participants Achieving Steroid-free CR-100 at Week 152 (2 Years of Participation in NCT01070303) |
9; 15 | — |
| SECONDARY Number of Participants Achieving Steroid-free CR-100 at Week 212 (3 Years of Participation in NCT01070303) |
6; 12 | — |
| SECONDARY Number of Participants Achieving Steroid-free CR-100 at Week 260 (4 Years of Participation in NCT01070303) |
2; 5 | — |
| SECONDARY Changes in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores |
42.4; 47.9; 51.0; 51.7 | — |
| SECONDARY Number of Participants Achieving Fistula Remission at Week 104 (1 Year of Participation in NCT01070303) |
1; 11 | — |
| SECONDARY Number of Participants Achieving Fistula Remission at Week 152 (2 Years of Participation in NCT01070303) |
2; 11 | — |
| SECONDARY Number of Participants Achieving Fistula Remission at Week 212 (3 Years of Participation in NCT01070303) |
1; 10 | — |
| SECONDARY Number of Participants Achieving Fistula Remission at Week 260 (Years of Participation in NCT01070303) |
2; 6 | — |
Eligibility Criteria
Inclusion Criteria
- Participant had completed the Year 1 of Study M02-433 (NCT00055497)
- Diagnosis of Crohn's disease
- Willing and able to give informed consent
Exclusion Criteria
- Diagnosis of ulcerative colitis
- Pregnancy or breastfeeding
- Previous use of infliximab or other anti-TNF (tumor necrosing factor) antagonists
- Previous history of active tuberculosis or listeria infection
- Previous history of cancer other than successfully treated skin cancer
Data sourced from ClinicalTrials.gov (NCT01070303). 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.