At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 177 enrolled
Drug / intervention
Adalimumab 40 mg eow or ewbiological
Likely dose
Adalimumab 40 mg eow or ewfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
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, Open Label Extension
In Brief
A Phase 3 clinical trial evaluating Adalimumab 40 mg eow or ew for Crohn's Disease. Completed, enrolled 177 participants across 43 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2002
Primary CompletionDec 2008
First PostedFeb 2010
TodayJul 2026
First PostedFeb 18, 2010
Enrollment StartAug 1, 2002
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 16.4 years ago
Interventions
Adalimumab 40 mg eow or ewbiological
Adalimumab 40 mg by subcutaneous injection every other week or every week