At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 576 enrolled

Drug / intervention

adalimumab +2 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.

Search/NCT00385736

NCT00385736Phase 3Completed

Compare CT.gov

A Multicenter, Randomized, Double-blind Placebo-controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderately to Severely Active Ulcerative Colitis

Abbott·interventional·Posted Oct 11, 2006·Updated Apr 11, 2011

In Brief

A Phase 3 clinical trial evaluating adalimumab and placebo for Ulcerative Colitis. Completed, enrolled 576 participants across 80 sites in 13 countries.

Detailed Summary

The objective of this study is to assess the efficacy and safety of adalimumab for the induction of clinical remission in subjects with moderately to severely active ulcerative colitis.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsUlcerative Colitis

CountriesAustria, Belgium, Canada, Czechia, Germany, Hungary, Italy, Netherlands, Poland, Puerto Rico, Slovakia, Sweden, United States

Collaborators--

Timeline

Phase 3CompletedFinished

200720082009201020112012201320142015201620172018201920202021202220232024202520262027

First PostedOct 2006

Enrollment StartNov 2006

Primary CompletionApr 2009

Study CompletionMar 2010

TodayJul 2026

First PostedOct 11, 2006

Enrollment StartNov 1, 2006

Primary CompletionApr 1, 2009

Study CompletionMar 1, 2010

TodayJul 2, 2026

Enrollment to primary: 2.4 yearsPosted 19.7 years ago

Interventions

adalimumabbiological

Prefilled syringe, 40 mg (loading dose then every other week dosing). 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.

adalimumabbiological

Prefilled syringe, 40 mg (loading dose then every other week dosing). 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.

placebobiological

Placebo for 40 mg syringe. Matching placebo for loading dose and every other week dosing. Subjects received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab eow thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).