A Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease

Phase 2

Completed

• Conditions: Crohn's Disease

• Registration Number: NCT00055523
• Lead Sponsor: Abbott

Brief Summary

Purpose of the study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease when compared to placebo (an inactive substance)

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Study First Submitted: 2003-03-04
• Study First Submitted QC: 2003-03-05
• Study First Posted: 2003-03-06
• Status Verified: 2006-08
• Last Update Submitted: 2006-08-11
• Last Update Posted: 2006-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
(achievement of a CDAI <150) of adalimumab 40 mg and 80 mg vs. placebo at Week 4.
comparison of the induction of clinical remission

Trial Locations

Locations (43)

Gastroenterology Associates of the East Bay; 🇺🇸 Berkeley, California, United States

Long Beach Gastroenterology Assoc.; 🇺🇸 Long Beach, California, United States

Sharp Rees-Stealy Medical Group; 🇺🇸 San Diego, California, United States

Gastroenterology Assoc. of Fairfield Co.; 🇺🇸 Bridgeport, Connecticut, United States

Cleveland Clinic Florida; 🇺🇸 Weston, Florida, United States

Shafran Gastroenterology Center; 🇺🇸 Winter Park, Florida, United States

Atlanta Gastroenterology Assoc.; 🇺🇸 Atlanta, Georgia, United States

Southeastern Digestive & Liver Disease; 🇺🇸 Savannah, Georgia, United States

Northwest Gastroenterologists, S.C.; 🇺🇸 Arlington Heights, Illinois, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

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