Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease
CHARM
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
1 other identifier
interventional
854
1 country
43
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedFirst Submitted
Initial submission to the registry
February 12, 2004
CompletedFirst Posted
Study publicly available on registry
February 16, 2004
CompletedSeptember 26, 2007
September 1, 2007
February 12, 2004
September 23, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical remission (CDAI<150).
56 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (43)
Thornton Hospital Reumatology Division
La Jolla, California, 92037-0943, United States
UCSF San Francisco General Hospital
San Francisco, California, 94110, United States
Cal-West, Inc.
San Francisco, California, 94117, United States
Western States Clinical Research
Arvada, Colorado, 80002, United States
Gastroenterology Associates of Fairfield County
Bridgeport, Connecticut, 06606, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765, United States
V.A. Medical Center
Gainsville, Florida, 32608, United States
Mark Lamet, MD
Hollywood, Florida, 33021, United States
Gastroenterology Consultants
Ormond Beach, Florida, 32174, United States
Northwest Gastroenterology
Arlington Heights, Illinois, 60005, United States
Northwestern University
Chicago, Illinois, 60611, United States
The University of Chicago
Chicago, Illinois, 60637, United States
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, 46237, United States
St. Vincent Hospital: Research Department
Indianapolis, Indiana, 46260, United States
Drug Research Services, Inc.
Metairie, Louisiana, 70001, United States
Maryland Clinical Trials
Annapolis, Maryland, 21401, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
Capital Gastroenterology Consultants, P.A.
Silver Spring, Maryland, 20901, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01610, United States
Mayo Clinic Research
Rochester, Minnesota, 55905-0002, United States
Gastroenterology & Hematology
Kansas City, Missouri, 64131, United States
Glenn Gordon, MD
Mexico, Missouri, 65265, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Washington University School
St Louis, Missouri, 63110, United States
Long Island Clinical Research Assoc.
Great Neck, New York, 11021, United States
NY Center for Clinical Research
Lake Success, New York, 11042, United States
Daniel Present, MD
New York, New York, 10029, United States
Digestive Disease Associates of Rockland
Pomona, New York, 10970, United States
Charlotte Gastroenterology & Hepatology
Charlotte, North Carolina, 28207, United States
Carolina Digestive Health Associates
Charlotte, North Carolina, 28211, United States
Carolina Research Associates
Charlotte, North Carolina, 28262, United States
Le Bauer Research, P.A.
Greensboro, North Carolina, 27403, United States
Wilmington Gastroenterology
Wilmington, North Carolina, 28401, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
Westhills Gastroenterology
Portland, Oregon, 98112, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15261, United States
Columbia Gastro Associates
Columbia, South Carolina, 29204, United States
Gastroenterology Center of the Mid South
Memphis, Tennessee, 38120, United States
Nashville Medical Research
Nashville, Tennessee, 37205, United States
Gastrointestinal Specialists
Richmond, Virginia, 23230, United States
Discovery Research Inteternational, LLC
Milwaukee, Wisconsin, 53215, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53215, United States
Related Publications (6)
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.
PMID: 34546360DERIVEDRyan 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.
PMID: 29380251DERIVEDPanaccione 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.
PMID: 24134498DERIVEDSchreiber 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.
PMID: 22704916DERIVEDKamm 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.
PMID: 21645018DERIVEDColombel 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.
PMID: 19201775DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Paul F Pollack, M.D.
Abbott
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 12, 2004
First Posted
February 16, 2004
Study Start
July 1, 2003
Last Updated
September 26, 2007
Record last verified: 2007-09