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

August 11, 2006 updated by: Abbott

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

Purpose of the study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease when compared to placebo (an inactive substance)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

300

Phase

  • Phase 2

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
      • Berkeley, California, United States, 94705
        • Gastroenterology Associates of the East Bay
      • Long Beach, California, United States, 90806
        • Long Beach Gastroenterology Assoc.
      • San Diego, California, United States, 92123
        • Sharp Rees-Stealy Medical Group
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • Gastroenterology Assoc. of Fairfield Co.
    • Florida
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida
      • Winter Park, Florida, United States, 32789
        • Shafran Gastroenterology Center
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Atlanta Gastroenterology Assoc.
      • Savannah, Georgia, United States, 31404
        • Southeastern Digestive & Liver Disease
    • Illinois
      • Arlington Heights, Illinois, United States, 600005
        • Northwest Gastroenterologists, S.C.
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Louisiana
      • Metairie, Louisiana, United States, 70001
        • Drug Research Services, Inc.
      • New Orleans, Louisiana, United States, 70115
        • LSU School of Medicine
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Digestive Disorders Associates
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 002115
        • Brigham and Women's Hospital
      • Worcester, Massachusetts, United States, 01610
        • Clinical Pharmacology Study Group
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic and Mayo Foundation
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • Gastroenterology and Hepatology
      • Mexico, Missouri, United States, 65265
        • Glenn Gordon, MD
    • Montana
      • Billings, Montana, United States, 59101
        • Deaconess Billings Clinic Research Division
    • Nebraska
      • Lincoln, Nebraska, United States, 68503
        • Gastroenterology Specialties, P.C.
    • New York
      • Great Neck, New York, United States, 11021
        • Long Island Clinical Research Associates
      • Lake Success, New York, United States, 11042
        • NY Center for Clinical Research
      • New York, New York, United States, 10021
        • New York Presbyterian Hospital
      • New York, New York, United States, 10029
        • Daniel Present
      • Rochester, New York, United States, 14607
        • Rochester Institute for Digestive Diseases
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC School of Medicine
      • Charlotte, North Carolina, United States, 28262
        • Carolina Research Associates
      • Charlotte, North Carolina, United States, 28207
        • Charlotte Gastroenterology and Hepatology
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates
      • Winston-Salem, North Carolina, United States, 27103
        • Digestive Health Specialists
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Consultants for Clinical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma Foundation for Digestive Disease
      • Tulsa, Oklahoma, United States, 74104
        • Research Solutions
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clinical Research
      • Pittsburgh, Pennsylvania, United States, 15224
        • Peter Molloy, MD
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Diseases of the Digestive System
      • Nashville, Tennessee, United States, 37205
        • Nashville Medical Research Institute
    • Virginia
      • Charlottesville, Virginia, United States, 22902
        • Charlottesville Medical Research
    • Washington
      • Bellevue, Washington, United States, 98004
        • Northwest Gastroenterology
      • Spokane, Washington, United States, 99204
        • Inland Empire Gastroenterology
      • Tacoma, Washington, United States, 98405
        • Tacoma Digestive Disease Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53702
        • Wisconsin Center for Advanced Research

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:

  • Diagnosis of Crohn's disease
  • CDAI score at baseline of between 220 and 450
  • Normal laboratory parameters
  • Willing and able to give informed consent

Exclusion:

  • Diagnosis of ulcerative colitis
  • Women cannot be pregnant or breastfeeding
  • No previous use of infliximab or other anti-TNF antagonists
  • No previous history of tuberculosis or listeria infection
  • No previous history of cancer other than successfully treated skin cancer

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: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
comparison of the induction of clinical remission
(achievement of a CDAI <150) of adalimumab 40 mg and 80 mg vs. placebo at Week 4.

Collaborators and Investigators

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

Sponsor

Abbott

Investigators

  • Principal Investigator: Stephen B Hanauer, MD, University of Chicago Department of Medicine

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

April 1, 2002

Study Registration Dates

First Submitted

March 4, 2003

First Submitted That Met QC Criteria

March 5, 2003

First Posted (Estimate)

March 6, 2003

Study Record Updates

Last Update Posted (Estimate)

August 15, 2006

Last Update Submitted That Met QC Criteria

August 11, 2006

Last Verified

August 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M02-403

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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