At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 514 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 Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration
In Brief
A Phase 3 clinical trial evaluating Adalimumab and Placebo for Crohn's Disease. Completed, enrolled 514 participants across 143 sites in 20 countries.
Detailed Summary
This study will evaluate higher versus standard adalimumab dosing regimens for induction and maintenance therapy in subjects with moderately to severely active Crohn's Disease and evidence of mucosal ulceration.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesAustria, Belgium, Canada, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Puerto Rico, Romania, Slovakia, Spain, Switzerland, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 2014
Enrollment StartMay 2014
Primary CompletionJan 2020
TodayJul 2026
First PostedFeb 19, 2014
Enrollment StartMay 1, 2014
Primary CompletionJan 30, 2020
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 12.4 years ago
Interventions
Adalimumabdrug
Placebodrug