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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Induction of clinical remission (CDAI score < 150 at Week 4)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2006

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2006

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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