Phase 3
Completed N=276
Remission in Subjects With Crohn's Disease, 1 Year Phase
Source: ClinicalTrials.gov NCT00055497 ↗Enrolled (actual)
276
Serious AEs
14.5%
Results posted
May 2010
Primary outcomePrimary: Number of Randomized Participants Achieving Clinical Remission at Week 56 - Non-Responder Imputation (NRI) — 6; 9; 12 Participants — p=0.142
Summary
The objectives were: (1) To demonstrate the efficacy of adalimumab in the maintenance of clinical remission up to 56 weeks in participants with Crohn's disease who participated in NCT00055523; (2) To delineate the safety of adalimumab when administered to participants with Crohn's disease up to 56 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Randomized Participants Achieving Clinical Remission at Week 56 - Non-Responder Imputation (NRI) |
6; 9; 12 | 0.142 |
| PRIMARY Number of Randomized Participants Achieving Clinical Remission at Week 56 - Last Observation Carried Forward (LOCF) |
8; 15; 15 | 0.029 sig |
| SECONDARY Number of Participants Achieving Clinical Remission at Week 24 - NRI |
7; 11; 17; 74 | — |
| SECONDARY Number of OL Participants Achieving Clinical Remission at Week 56 - NRI |
74 | — |
| SECONDARY Number of Participants Achieving Clinical Response 100 (CR-100) - NRI |
7; 11; 17; 110; 6; 9 | 0.330 |
| SECONDARY Number of Participants Achieving Clinical Response 70 (CR-70)- NRI |
8; 13; 17; 123; 6; 9 | 0.191 |
| SECONDARY Number of Participants Achieving Clinical Remission at Week 24 - LOCF |
7; 11; 17; 82 | 0.001 sig |
| SECONDARY Number of OL Participants Achieving Clinical Remission at Week 56 - LOCF |
93 | — |
| SECONDARY Number of Participants Achieving CR-100 - LOCF |
7; 11; 17; 110; 6; 9 | — |
| SECONDARY Number of Participants Achieving CR-70 - LOCF |
15; 18; 17; 144; 13; 15 | — |
| SECONDARY Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores - LOCF |
29.9; 43.4; 51.9; 33.9; 24.7; 45.7 | — |
Eligibility Criteria
Inclusion:
- Patient must have successfully completed the induction study NCT00055523
- Diagnosis of Crohn's disease
- Willing and able to give informed consent
Exclusion:
- Diagnosis of ulcerative colitis
- Pregnancy or breastfeeding
- Previous use of infliximab or other anti-TNF antagonists
- Previous history of active tuberculosis or listeria infection
- Previous history of cancer other than successfully treated skin cancer
Data sourced from ClinicalTrials.gov (NCT00055497). 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.