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

Last updated: September 23, 2007
Sponsor: Abbott
Overall Status: Completed

Phase

3

Condition

Ulcerative Colitis

Inflammatory Bowel Disease

Colic

Treatment

N/A

Clinical Study ID

NCT00077779
M02-404
  • Ages 18-75
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

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

Total Participants: 854
Study Start date:
July 01, 2003
Estimated Completion Date:

Connect with a study center

  • Thornton Hospital Reumatology Division

    La Jolla, California 92037-0943
    United States

    Site Not Available

  • Cal-West, Inc.

    San Francisco, California 94117
    United States

    Site Not Available

  • UCSF San Francisco General Hospital

    San Francisco, California 94110
    United States

    Site Not Available

  • Western States Clinical Research

    Arvada, Colorado 80002
    United States

    Site Not Available

  • Gastroenterology Associates of Fairfield County

    Bridgeport, Connecticut 06606
    United States

    Site Not Available

  • Clinical Research of West Florida, Inc.

    Clearwater, Florida 33765
    United States

    Site Not Available

  • V.A. Medical Center

    Gainsville, Florida 32608
    United States

    Site Not Available

  • Mark Lamet, MD

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Gastroenterology Consultants

    Ormond Beach, Florida 32174
    United States

    Site Not Available

  • Northwest Gastroenterology

    Arlington Heights, Illinois 60005
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • The University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Indianapolis Gastroenterology Research Foundation

    Indianapolis, Indiana 46237
    United States

    Site Not Available

  • St. Vincent Hospital: Research Department

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • Drug Research Services, Inc.

    Metairie, Louisiana 70001
    United States

    Site Not Available

  • Maryland Clinical Trials

    Annapolis, Maryland 21401
    United States

    Site Not Available

  • Chevy Chase Clinical Research

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • Capital Gastroenterology Consultants, P.A.

    Silver Spring, Maryland 20901
    United States

    Site Not Available

  • Clinical Pharmacology Study Group

    Worcester, Massachusetts 01610
    United States

    Site Not Available

  • Mayo Clinic Research

    Rochester, Minnesota 55905-0002
    United States

    Site Not Available

  • Gastroenterology & Hematology

    Kansas City, Missouri 64131
    United States

    Site Not Available

  • Glenn Gordon, MD

    Mexico, Missouri 65265
    United States

    Site Not Available

  • Washington University School

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Long Island Clinical Research Assoc.

    Great Neck, New York 11021
    United States

    Site Not Available

  • NY Center for Clinical Research

    Lake Success, New York 11042
    United States

    Site Not Available

  • Daniel Present, MD

    New York, New York 10029
    United States

    Site Not Available

  • Digestive Disease Associates of Rockland

    Pomona, New York 10970
    United States

    Site Not Available

  • Carolina Digestive Health Associates

    Charlotte, North Carolina 28211
    United States

    Site Not Available

  • Carolina Research Associates

    Charlotte, North Carolina 28262
    United States

    Site Not Available

  • Charlotte Gastroenterology & Hepatology

    Charlotte, North Carolina 28207
    United States

    Site Not Available

  • Le Bauer Research, P.A.

    Greensboro, North Carolina 27403
    United States

    Site Not Available

  • Wilmington Gastroenterology

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • University Hospitals of Cleveland

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Westhills Gastroenterology

    Portland, Oregon 98112
    United States

    Site Not Available

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15261
    United States

    Site Not Available

  • Columbia Gastro Associates

    Columbia, South Carolina 29204
    United States

    Site Not Available

  • Gastroenterology Center of the Mid South

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • Nashville Medical Research

    Nashville, Tennessee 37205
    United States

    Site Not Available

  • Gastrointestinal Specialists

    Richmond, Virginia 23230
    United States

    Site Not Available

  • Discovery Research Inteternational, LLC

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

  • Wisconsin Center for Advanced Research

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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