At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 952 enrolled
Drug / intervention
Adalimumab +1 moredrug
Likely dose
Not stated in 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 Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
In Brief
A Phase 3 clinical trial evaluating Adalimumab and Placebo for Ulcerative Colitis (UC). Completed, enrolled 952 participants across 173 sites in 20 countries.
Detailed Summary
To evaluate safety and efficacy of two adalimumab dosing regimens for induction and maintenance (standard and higher dosing) in achieving clinical remission in subjects with moderately to severely active ulcerative colitis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis (UC)
CountriesAustria, Belgium, Canada, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Netherlands, Poland, Romania, Slovakia, Spain, Switzerland, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 2014
Enrollment StartMar 2014
Primary CompletionSep 2019
Study CompletionNov 2019
TodayJul 2026
First PostedFeb 19, 2014
Enrollment StartMar 27, 2014
Primary CompletionSep 5, 2019
Study CompletionNov 11, 2019
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 12.4 years ago
Interventions
Adalimumabdrug
Placeboother