Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease

August 13, 2006 updated by: Abbott

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderate to Severe Crohn's Disease Who Have Lost Response or Are Intolerant to Infliximab

The goal of this study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease who have been initially treated with infliximab and either lost response or discontinued its use as a result of intolerance to the drug.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

300

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

  • Belgium
      • Bonheiden, Belgium, 2820
        • Imelda Ziekenhuis
      • Leuven, Belgium
        • UZ Gasthuisberg
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • Heritage Medical Research Clinic Health Sciences Centre University of Calgary
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St. Paul's Hospital
      • Vancouver, British Columbia, Canada, V5Z 1H2
        • Liver and Intestinal Disease Research Center
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Winnipeg Health Sciences Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Queen Elizabeth II Health Sciences Centre
    • Ontario
      • Toronto, Ontario, Canada, M3N 2V7
        • Toronto Digestive Disease Assoc. Inc
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • Royal Victoria Hospital
  • France
    • Cedex
      • Lille, Cedex, France, 59037
        • Hopital Claude Claude Huriez Hospital
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Clinical Research Associates
    • California
      • Roseville, California, United States, 95661
        • Capitol Gastroenterology Consultants Medical Group, Inc.
      • San Diego, California, United States, 92123
        • Medical Associates Research Group
      • San Diego, California, United States, 92123
        • Sharp Rees-Stealy Medical Group
    • Colorado
      • Englewood, Colorado, United States, 80113
        • SMC-Trauma Research
    • Florida
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida, Inc
      • Gainesville, Florida, United States, 32608
        • V.A. Medical Center
      • Jacksonville, Florida, United States, 32256
        • Borland-Groover Clinic
      • Winter Park, Florida, United States, 32789
        • Shafran Gastroenterology Center
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Pinnacle Trials, Inc.
      • Atlanta, Georgia, United States, 30342
        • Atlanta Gastroenterology Assoc.
    • Illinois
      • Chicago, Illinois, United States, 60673
        • The University of Chicago
      • Peoria, Illinois, United States, 60602
        • nTouch Research
    • Indiana
      • Indianapolis, Indiana, United States, 462025250
        • Outpatient Clinical Research Facility University of Indianapolis
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Medical Center Division of Digestive Diseases
    • Louisiana
      • Metairie, Louisiana, United States, 70001
        • Drug Research Services, Inc.
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Chevy Chase Clinical Research
      • Towson, Maryland, United States, 21204
        • Charm City Research
    • Minnesota
      • Plymouth, Minnesota, United States, 55446
        • Minnesota Gastroenterology P.A.
      • Rochester, Minnesota, United States, 559050002
        • Mayo Clinic Research
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Gastrointestinal Associated, P.A.
    • Missouri
      • Mexico, Missouri, United States, 65265
        • Glen Gordon, MD
      • St. Louis, Missouri, United States, 63128
        • St. Louis Center for Clinical Research
    • New Jersey
      • Egg Harbor Township, New Jersey, United States, 08234
        • Atlantic Gastroenterology Associates, LLC
    • New York
      • Great Neck, New York, United States, 11021
        • Long Island Clinical Research Assoc. LLP
      • Lake Success, New York, United States, 11042
        • NY Center for Clinical Research
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine IBD Research Center
    • North Carolina
      • Ashville, North Carolina, United States, 28801
        • Asheville Gastroenterology Associates
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Consultants for Clinical Research
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Dayton, Ohio, United States, 45440
        • Gastrointestinal and Liver Disease Consultants
      • Mayfield Heights, Ohio, United States, 44124
        • Gastroenterology Associates of Cleveland
    • Oregon
      • Portland, Oregon, United States, 97220
        • The Oregon Clinic, PC Gastroenterology Division
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17604
        • Regional Gastroenterologist Associates of Lancaster
      • Pittsburgh, Pennsylvania, United States, 15261
        • University of Pittsburgh Medical Center
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • Columbia Gastro Associates
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Gastrointestinal Associates
      • Memphis, Tennessee, United States, 38120
        • Gastroenterology Center of the Mid South
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Austin, Texas, United States, 78745
        • Austin Gastroenterology
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Wasatch Clinical Research
    • Virginia
      • Danville, Virginia, United States, 25451
        • Internal Medicine Associates
      • Norfolk, Virginia, United States, 23205
        • Digestive and Liver Disease
    • Washington
      • Spokane, Washington, United States, 99204
        • Spokane Digestive Disease Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53207
        • Discovery Research International, 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 Criteria:

  • Males and females between the ages of 18 and 75 who are diagnosed with mild to moderate Crohn's disease (defined by a CDAI [Crohn's Disease Activity Index] score of 220 and 450)
  • Normal lab parameters
  • Are willing to give informed consent
  • Have previously used and either were intolerant to or lost response to infliximab

Exclusion Criteria:

  • History of certain types of cancer
  • Diagnosis of ulcerative colitis
  • Pregnant female or breast feeding subjects
  • Known obstructive strictures
  • Surgical bowel resection in the past 6 months
  • History of listeria, human immunodeficiency virus (HIV), central nervous system demyelinating disease or untreated TB (tuberculosis)
  • History of poorly controlled medical conditions
  • Specific doses and durations of Crohn's medications
  • Subjects that have previously used infliximab and have never clinically responded unless primary non-response was due to a treatment limiting reaction to infliximab

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
Induction of clinical remission (CDAI score < 150 at Week 4)

Secondary Outcome Measures

Outcome Measure
Clinical response measured as
Decrease in Baseline CDAI score >= 70 points at Week 4
Decrease in Baseline CDAI score >= 100 points at Week 4
Changes in IBDQ scores at Week 4

Collaborators and Investigators

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

Sponsor

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

October 1, 2004

Study Registration Dates

First Submitted

March 11, 2005

First Submitted That Met QC Criteria

March 11, 2005

First Posted (Estimate)

March 14, 2005

Study Record Updates

Last Update Posted (Estimate)

August 15, 2006

Last Update Submitted That Met QC Criteria

August 13, 2006

Last Verified

August 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M04-691

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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