Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease
NCT ID: NCT00077779
Last Updated: 2007-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
854 participants
INTERVENTIONAL
2003-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Adalimumab
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Principal Investigators
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Paul F Pollack, M.D.
Role: STUDY_DIRECTOR
Abbott
Locations
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Thornton Hospital Reumatology Division
La Jolla, California, United States
UCSF San Francisco General Hospital
San Francisco, California, United States
Cal-West, Inc.
San Francisco, California, United States
Western States Clinical Research
Arvada, Colorado, United States
Gastroenterology Associates of Fairfield County
Bridgeport, Connecticut, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States
V.A. Medical Center
Gainsville, Florida, United States
Mark Lamet, MD
Hollywood, Florida, United States
Gastroenterology Consultants
Ormond Beach, Florida, United States
Northwest Gastroenterology
Arlington Heights, Illinois, United States
Northwestern University
Chicago, Illinois, United States
The University of Chicago
Chicago, Illinois, United States
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, United States
St. Vincent Hospital: Research Department
Indianapolis, Indiana, United States
Drug Research Services, Inc.
Metairie, Louisiana, United States
Maryland Clinical Trials
Annapolis, Maryland, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Capital Gastroenterology Consultants, P.A.
Silver Spring, Maryland, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
Mayo Clinic Research
Rochester, Minnesota, United States
Gastroenterology & Hematology
Kansas City, Missouri, United States
Glenn Gordon, MD
Mexico, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Washington University School
St Louis, Missouri, United States
Long Island Clinical Research Assoc.
Great Neck, New York, United States
NY Center for Clinical Research
Lake Success, New York, United States
Daniel Present, MD
New York, New York, United States
Digestive Disease Associates of Rockland
Pomona, New York, United States
Charlotte Gastroenterology & Hepatology
Charlotte, North Carolina, United States
Carolina Digestive Health Associates
Charlotte, North Carolina, United States
Carolina Research Associates
Charlotte, North Carolina, United States
Le Bauer Research, P.A.
Greensboro, North Carolina, United States
Wilmington Gastroenterology
Wilmington, North Carolina, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Westhills Gastroenterology
Portland, Oregon, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Columbia Gastro Associates
Columbia, South Carolina, United States
Gastroenterology Center of the Mid South
Memphis, Tennessee, United States
Nashville Medical Research
Nashville, Tennessee, United States
Gastrointestinal Specialists
Richmond, Virginia, United States
Discovery Research Inteternational, LLC
Milwaukee, Wisconsin, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States
Countries
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References
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Sandborn WJ, Lewis JD, Panes J, Loftus EV, D'Haens G, Yu Z, Huang B, Lacerda AP, Pangan AL, Feagan BG. Association Between Proposed Definitions of Clinical Remission/Response and Well-Being in Patients With Crohn's Disease. J Crohns Colitis. 2022 Mar 14;16(3):444-451. doi: 10.1093/ecco-jcc/jjab161.
Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6.
Panaccione R, Colombel JF, Sandborn WJ, D'Haens G, Zhou Q, Pollack PF, Thakkar RB, Robinson AM. Adalimumab maintains remission of Crohn's disease after up to 4 years of treatment: data from CHARM and ADHERE. Aliment Pharmacol Ther. 2013 Nov;38(10):1236-47. doi: 10.1111/apt.12499. Epub 2013 Sep 22.
Schreiber S, Reinisch W, Colombel JF, Sandborn WJ, Hommes DW, Robinson AM, Huang B, Lomax KG, Pollack PF. Subgroup analysis of the placebo-controlled CHARM trial: increased remission rates through 3 years for adalimumab-treated patients with early Crohn's disease. J Crohns Colitis. 2013 Apr;7(3):213-21. doi: 10.1016/j.crohns.2012.05.015. Epub 2012 Jun 16.
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. doi: 10.1111/j.1365-2036.2011.04717.x. 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. doi: 10.1136/gut.2008.159251. Epub 2009 Feb 6.
Other Identifiers
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M02-404
Identifier Type: -
Identifier Source: org_study_id