Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease

Crohn's Disease Clinical Trial

— CHARM  

Official title:

A Multi-Center Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00077779
• Other study ID #: M02-404
• Status: Completed
• Phase: Phase 3
• First received: February 12, 2004
• Last updated: September 23, 2007
• Start date: July 2003

Study information

• Verified date: September 2007
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test whether Adalimumab (at two different doses) can induce and maintain clinical remission in subjects with active Crohn's disease when compared to placebo (a substance containing no medication)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 854
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion:

• Males and females between the ages of 18 and 75 who are diagnosed with moderate to severe Crohn's Disease defined by a CDAI score of >= 220 and <= 450, normal laboratory parameters,

• are willing and able to give informed consent, and

• are able to self-inject or have a designee or healthcare professional who can inject the study medication.

Exclusion:

• History of certain types of cancer, diagnosis of ulcerative colitis,

• female or breast feeding subjects,

• surgical bowel resection(s) with in the past 6 months,

• history of listeria,

• human immunodeficiency virus (HIV),

• central nervous system demyelinating disease or untreated TB,

• history of a poorly controlled medical condition,

• unsuccessful response to infliximab or any anti-TNF agent use in the past.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Adalimumab

Locations

Country	Name	City	State
United States	Maryland Clinical Trials	Annapolis	Maryland
United States	Northwest Gastroenterology	Arlington Heights	Illinois
United States	Western States Clinical Research	Arvada	Colorado
United States	Gastroenterology Associates of Fairfield County	Bridgeport	Connecticut
United States	Carolina Digestive Health Associates	Charlotte	North Carolina
United States	Carolina Research Associates	Charlotte	North Carolina
United States	Charlotte Gastroenterology & Hepatology	Charlotte	North Carolina
United States	Chevy Chase Clinical Research	Chevy Chase	Maryland
United States	Northwestern University	Chicago	Illinois
United States	The University of Chicago	Chicago	Illinois
United States	Clinical Research of West Florida, Inc.	Clearwater	Florida
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Columbia Gastro Associates	Columbia	South Carolina
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	V.A. Medical Center	Gainsville	Florida
United States	Long Island Clinical Research Assoc.	Great Neck	New York
United States	Le Bauer Research, P.A.	Greensboro	North Carolina
United States	Mark Lamet, MD	Hollywood	Florida
United States	Indianapolis Gastroenterology Research Foundation	Indianapolis	Indiana
United States	St. Vincent Hospital: Research Department	Indianapolis	Indiana
United States	Gastroenterology & Hematology	Kansas City	Missouri
United States	Thornton Hospital Reumatology Division	La Jolla	California
United States	NY Center for Clinical Research	Lake Success	New York
United States	Gastroenterology Center of the Mid South	Memphis	Tennessee
United States	Drug Research Services, Inc.	Metairie	Louisiana
United States	Glenn Gordon, MD	Mexico	Missouri
United States	Discovery Research Inteternational, LLC	Milwaukee	Wisconsin
United States	Wisconsin Center for Advanced Research	Milwaukee	Wisconsin
United States	Nashville Medical Research	Nashville	Tennessee
United States	Daniel Present, MD	New York	New York
United States	Gastroenterology Consultants	Ormond Beach	Florida
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Digestive Disease Associates of Rockland	Pomona	New York
United States	Westhills Gastroenterology	Portland	Oregon
United States	Gastrointestinal Specialists	Richmond	Virginia
United States	Mayo Clinic Research	Rochester	Minnesota
United States	Cal-West, Inc.	San Francisco	California
United States	UCSF San Francisco General Hospital	San Francisco	California
United States	Capital Gastroenterology Consultants, P.A.	Silver Spring	Maryland
United States	Washington University School	St. Louis	Missouri
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Wilmington Gastroenterology	Wilmington	North Carolina
United States	Clinical Pharmacology Study Group	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical remission (CDAI<150).		56 weeks