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

Purpose

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)

Condition	Intervention	Phase
Crohn's Disease	Drug: Adalimumab	Phase 3

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

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Adalimumab

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Clinical remission (CDAI<150). [ Time Frame: 56 weeks ]

Enrollment:	854
Study Start Date:	July 2003

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077779

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Locations

United States, California
Thornton Hospital Reumatology Division
La Jolla, California, United States, 92037-0943
UCSF San Francisco General Hospital
San Francisco, California, United States, 94110
Cal-West, Inc.
San Francisco, California, United States, 94117
United States, Colorado
Western States Clinical Research
Arvada, Colorado, United States, 80002
United States, Connecticut
Gastroenterology Associates of Fairfield County
Bridgeport, Connecticut, United States, 06606
United States, Florida
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States, 33765
V.A. Medical Center
Gainsville, Florida, United States, 32608
Mark Lamet, MD
Hollywood, Florida, United States, 33021
Gastroenterology Consultants
Ormond Beach, Florida, United States, 32174
United States, Illinois
Northwest Gastroenterology
Arlington Heights, Illinois, United States, 60005
Northwestern University
Chicago, Illinois, United States, 60611
The University of Chicago
Chicago, Illinois, United States, 60637
United States, Indiana
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, United States, 46237
St. Vincent Hospital: Research Department
Indianapolis, Indiana, United States, 46260
United States, Louisiana
Drug Research Services, Inc.
Metairie, Louisiana, United States, 70001
United States, Maryland
Maryland Clinical Trials
Annapolis, Maryland, United States, 21401
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States, 20815
Capital Gastroenterology Consultants, P.A.
Silver Spring, Maryland, United States, 20901
United States, Massachusetts
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States, 01610
United States, Minnesota
Mayo Clinic Research
Rochester, Minnesota, United States, 55905-0002
United States, Missouri
Gastroenterology & Hematology
Kansas City, Missouri, United States, 64131
Glenn Gordon, MD
Mexico, Missouri, United States, 65265
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Washington University School
St. Louis, Missouri, United States, 63110
United States, New York
Long Island Clinical Research Assoc.
Great Neck, New York, United States, 11021
NY Center for Clinical Research
Lake Success, New York, United States, 11042
Daniel Present, MD
New York, New York, United States, 10029
Digestive Disease Associates of Rockland
Pomona, New York, United States, 10970
United States, North Carolina
Carolina Research Associates
Charlotte, North Carolina, United States, 28262
Carolina Digestive Health Associates
Charlotte, North Carolina, United States, 28211
Charlotte Gastroenterology & Hepatology
Charlotte, North Carolina, United States, 28207
Le Bauer Research, P.A.
Greensboro, North Carolina, United States, 27403
Wilmington Gastroenterology
Wilmington, North Carolina, United States, 28401
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
United States, Oregon
Westhills Gastroenterology
Portland, Oregon, United States, 98112
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15261
United States, South Carolina
Columbia Gastro Associates
Columbia, South Carolina, United States, 29204
United States, Tennessee
Gastroenterology Center of the Mid South
Memphis, Tennessee, United States, 38120
Nashville Medical Research
Nashville, Tennessee, United States, 37205
United States, Virginia
Gastrointestinal Specialists
Richmond, Virginia, United States, 23230
United States, Wisconsin
Discovery Research Inteternational, LLC
Milwaukee, Wisconsin, United States, 53215
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States, 53215

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Paul F Pollack, M.D.

Abbott

More Information

No publications provided by Abbott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kamm MA, Hanauer SB, Panaccione R, Colombel JF, Sandborn WJ, Pollack PF, Zhou Q, Robinson AM. Adalimumab sustains steroid-free remission after 3 years of therapy for Crohn's disease. Aliment Pharmacol Ther. 2011 Aug;34(3):306-17. Epub 2011 Jun 5.

Colombel JF, Schwartz DA, Sandborn WJ, Kamm MA, D'Haens G, Rutgeerts P, Enns R, Panaccione R, Schreiber S, Li J, Kent JD, Lomax KG, Pollack PF. Adalimumab for the treatment of fistulas in patients with Crohn's disease. Gut. 2009 Jul;58(7):940-8. Epub 2009 Feb 6.

ClinicalTrials.gov Identifier:	NCT00077779 History of Changes
Other Study ID Numbers:	M02-404
Study First Received:	February 12, 2004
Last Updated:	September 23, 2007
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 16, 2013

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