CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 945 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.

Search/NCT00409617
NCT00409617Phase 3Completed
CompareCT.gov

A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Moderate to Severe Crohn's Disease

Abbott·interventional·Posted Dec 11, 2006·Updated Oct 10, 2011

In Brief

A Phase 3 clinical trial evaluating adalimumab for Crohn's Disease. Completed, enrolled 945 participants across 189 sites in 17 countries.

Detailed Summary

The purpose of this study is to evaluate the safety of adalimumab for treatment of patients with moderate to severe Crohn's Disease (CD) and to measure the effects of treatment on patient general well-being, health-related quality of life (QoL), fistula healing, CD-related extra-intestinal manifestations, work performance, and overall activity.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesAustria, Belgium, Czechia, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 11, 2006
Enrollment StartDec 1, 2006
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 19.6 years ago

Interventions

adalimumabbiological

Adalimumab 40 mg Every Other Week dosing

adalimumabbiological

Adalimumab 40 mg Every Week dosing if participant experiences a disease flare or is not responding to treatment. A disease flare is defined as an increase of 3 points or more on the HBI compared to the Baseline score and a total HBI score of 7 or higher. Non-response is defined as a decrease by fewer than 3 points in the HBI compared to Baseline.