At a glance
ClinicalIndex Comparison Record- ✓Successfully completed the induction study NCT00055523
- ✓Confirmed diagnosis of Crohn's disease
- ✓Willing and able to give informed consent
- ✕Diagnosis of ulcerative colitis
- ✕Pregnant or breastfeeding
- ✕Prior use of infliximab or other anti-TNF antagonists
- ✕History of active tuberculosis or listeria infection
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Maintenance of Clinical Remission in Subjects With Crohn's Disease
In Brief
A Phase 3 clinical trial evaluating Double-blind (DB) adalimumab placebo, DB adalimumab 40 mg eow, and 2 other interventions for Crohn's Disease. Completed, enrolled 276 participants across 43 sites.
Detailed 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.
Study Details
Timeline
Interventions
Double-blind nonactive matching subcutaneous injection
Double-blind adalimumab 40 mg every other week by subcutaneous injection
Double-blind adalimumab 40 mg every week by subcutaneous injection
Open-label adalimumab every other week or every week by subcutaneous injection