CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 274 enrolled
Drug / intervention
adalimumab +1 morebiological
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.

Search/NCT00853099
NCT00853099Phase 3Completed
CompareCT.gov

A Multi-Center, Randomized, Double-Blind, Placebo-controlled Study of Adalimumab in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis.

AbbVie (prior sponsor, Abbott)·interventional·Posted Mar 2, 2009·Updated Sep 5, 2014

In Brief

A Phase 3 clinical trial evaluating adalimumab and placebo for Ulcerative Colitis. Completed, enrolled 274 participants across 65 sites.

Detailed Summary

The purpose of this study is to assess the efficacy and safety of adalimumab in Japanese subjects with moderately to severely active ulcerative colitis (UC).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesJapan
CollaboratorsEisai Co., Ltd.

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2, 2009
Enrollment StartFeb 1, 2009
Primary CompletionMay 1, 2011
Study CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 17.3 years ago

Interventions

adalimumabbiological

placebodrug