Treatment of the Human Anti-TNF Monoclonal Antibody Adalimumab in Moderate to Severe Crohn's Disease With Previous Exposure to Infliximab (CHOICE)

Phase 3

Completed

• Conditions: Crohn's Disease

• Registration Number: NCT00338650
• Lead Sponsor: Abbott

Brief Summary

The primary objective of this study is to make adalimumab available to patients suffering from moderately to severely active Crohn's Disease who have failed to respond to, lost response to, or are intolerant to infliximab, and to evaluate safety

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-06-19
• Study First Submitted QC: 2006-06-19
• Study First Posted: 2006-06-20
• Study Completion: 2007-05
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-28
• Last Update Posted: 2007-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Patient diagnosed with moderate to severe Crohn's Disease.
• Failed prior infliximab therapy.
• Patient is judged to be in generally good health as determined by the principal investigator.

Exclusion Criteria

• Previous treatment with adalimumab.
• Patient considered by the investigator, for any reason, to be an unsuitable candidate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
AEs, laboratory data, physical examinations and vital signs

Secondary Outcome Measures

Name	Time	Method
Efficacy variables will be assessed from Outcomes Questionnaires