At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 90 enrolled
Drug / intervention
adalimumab +2 morebiological
Likely dose
adalimumab 160 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 Induction 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 90 participants across 18 sites.
Detailed Summary
The purpose of this study is to demonstrate the efficacy and safety of adalimumab for the induction of clinical remission in Japanese subjects with Crohn's disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesJapan
CollaboratorsAbbott Japan Co.,Ltd, Eisai Co., Ltd.
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2007
First PostedMar 2007
Primary CompletionDec 2007
TodayJul 2026
First PostedMar 9, 2007
Enrollment StartFeb 1, 2007
Primary CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 19.3 years ago
Interventions
adalimumabbiological
160 mg at Week 0, 80 mg at Week 2
adalimumabbiological
80 mg at Week 0, 40 mg at Week 2
placebobiological
Placebo at Week 0 and Week 2