At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 135 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.

Search/NCT00348283

NCT00348283Phase 3Completed

Compare CT.gov

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects With Crohn's Disease Involving the Colon

Abbott·interventional·Posted Jul 4, 2006·Updated Apr 11, 2011

In Brief

A Phase 3 clinical trial evaluating adalimumab and placebo for Crohn's Disease. Completed, enrolled 135 participants across 21 sites in 8 countries.

Detailed Summary

The goal of this study was to test whether adalimumab can induce mucosal healing in subjects with moderate to severe ileocolonic Crohn's Disease.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsCrohn's Disease

CountriesAustria, Belgium, Canada, France, Germany, Italy, Netherlands, United States

Collaborators--

Timeline

Phase 3CompletedFinished

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

First PostedJul 2006

Enrollment StartAug 2006

Primary CompletionSep 2008

TodayJul 2026

First PostedJul 4, 2006

Enrollment StartAug 1, 2006

Primary CompletionSep 1, 2008

TodayJul 2, 2026

Enrollment to primary: 2.1 yearsPosted 20.0 years ago

Interventions

adalimumabbiological

At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow. Adalimumab 40 mg eow dosing through blinded portion of study, which continued through Week 52. While all subjects began blinded study drug (placebo or adalimumab), subjects could have switched to an OL dose of adalimumab upon disease flare or non-response at or after Week 8.

placebobiological

At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow. Placebo SC eow dosing through blinded portion of study, which continued through Week 52. While all subjects began blinded study drug (placebo or adalimumab), subjects could have switched to an OL dose of adalimumab upon disease flare or non-response at or after Week 8.

adalimumabbiological

At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow. Adalimumab or placebo SC eow dosing through blinded portion of study, which continued through Week 52. While all subjects began blinded study drug (placebo or adalimumab), subjects could have switched to an OL dose of adalimumab upon disease flare or non-response at or after Week 8. In the Open-Label arm, interventions were either adalimumab 40 mg SC eow or adalimumab 40 mg SC weekly. There was no placebo intervention post Week 52.