At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 518 enrolled
Drug / intervention
adalimumab +1 morebiological
Likely dose
adalimumab 40 mgfrom 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 Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Moderately to Severely Active Ulcerative Colitis
In Brief
A Phase 3 clinical trial evaluating adalimumab and placebo for Ulcerative Colitis. Completed, enrolled 518 participants across 108 sites in 18 countries.
Detailed Summary
This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of the human anti-tumor necrosis factor (TNF) monoclonal antibody adalimumab (ADA) in patients with moderately to severely active ulcerative colitis (UC).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesArgentina, Australia, Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Hungary, Israel, New Zealand, Norway, Poland, Portugal, Spain, Switzerland, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2006
First PostedDec 2006
Primary CompletionMar 2010
TodayJul 2026
First PostedDec 7, 2006
Enrollment StartNov 1, 2006
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 19.6 years ago
Interventions
adalimumabbiological
Prefilled syringe, 40 mg, 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week between Weeks 4 and 50.
placebobiological
Matching Placebo for prefilled syringe, 40 mg,