At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 82 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 Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohn's Disease
In Brief
A Phase 3 clinical trial evaluating adalimumab and Placebo for Crohn's Disease. Completed, enrolled 82 participants across 29 sites.
Detailed Summary
To demonstrate the efficacy and safety of adalimumab for the maintenance of clinical remission in Japanese subjects with Crohn's disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesJapan
CollaboratorsEisai Co., Ltd.
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2007
First PostedMar 2007
Primary CompletionMar 2009
Study CompletionNov 2010
TodayJul 2026
First PostedMar 9, 2007
Enrollment StartMar 1, 2007
Primary CompletionMar 1, 2009
Study CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 19.3 years ago
Interventions
adalimumabbiological
Subcutaneous injection of 40 mg adalimumab (0.8 mL/injection) every other week (eow)
Placeboother
Subcutaneous injection of placebo (0.8 mL/injection) every other week (eow)