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

September 23, 2007 updated by: Abbott

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

854

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical remission (CDAI<150).
Time Frame: 56 weeks
56 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Paul F Pollack, M.D., Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion

December 7, 2022

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

February 12, 2004

First Submitted That Met QC Criteria

February 13, 2004

First Posted (Estimate)

February 16, 2004

Study Record Updates

Last Update Posted (Estimate)

September 26, 2007

Last Update Submitted That Met QC Criteria

September 23, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M02-404

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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