CClinicalTrials.gg
CompletedNCT00105300Updated Aug 15, 2006

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

A Phase 3 interventional study of Adalimumab in Crohn's Disease, sponsored by Abbott. Completed at 56 sites in 4 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2006-08-15.

Sponsored by Abbott · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Crohn's Disease

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03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's enrollment of 300 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Abbott is the lead sponsor of 350 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
300 participants

Interventions

  • DrugAdalimumab
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  1. Clinical response measured as

  2. Decrease in Baseline CDAI score >= 70 points at Week 4

  3. Decrease in Baseline CDAI score >= 100 points at Week 4

  4. Changes in IBDQ scores at Week 4

07

Study locations

56 sites
  • Clinical Research Associates
    Huntsville, Alabama 35801, United States
  • Capitol Gastroenterology Consultants Medical Group, Inc.
    Roseville, California 95661, United States
  • Medical Associates Research Group
    San Diego, California 92123, United States
  • Sharp Rees-Stealy Medical Group
    San Diego, California 92123, United States
  • SMC-Trauma Research
    Englewood, Colorado 80113, United States
  • Clinical Research of West Florida, Inc
    Clearwater, Florida 33765, United States
  • V.A. Medical Center
    Gainesville, Florida 32608, United States
  • Borland-Groover Clinic
    Jacksonville, Florida 32256, United States
  • Shafran Gastroenterology Center
    Winter Park, Florida 32789, United States
  • Pinnacle Trials, Inc.
    Atlanta, Georgia 30329, United States
  • Atlanta Gastroenterology Assoc.
    Atlanta, Georgia 30342, United States
  • The University of Chicago
    Chicago, Illinois 60673, United States
  • Ntouch Research
    Peoria, Illinois 60602, United States
  • Outpatient Clinical Research Facility University of Indianapolis
    Indianapolis, Indiana 462025250, United States
  • University of Kentucky Medical Center Division of Digestive Diseases
    Lexington, Kentucky 40536, United States
  • Drug Research Services, Inc.
    Metairie, Louisiana 70001, United States
  • Chevy Chase Clinical Research
    Chevy Chase, Maryland 20815, United States
  • Charm City Research
    Towson, Maryland 21204, United States
  • Minnesota Gastroenterology P.A.
    Plymouth, Minnesota 55446, United States
  • Mayo Clinic Research
    Rochester, Minnesota 559050002, United States
  • Gastrointestinal Associated, P.A.
    Jackson, Mississippi 39202, United States
  • Glen Gordon, MD
    Mexico, Missouri 65265, United States
  • St. Louis Center for Clinical Research
    St. Louis, Missouri 63128, United States
  • Atlantic Gastroenterology Associates, LLC
    Egg Harbor Township, New Jersey 08234, United States
  • Long Island Clinical Research Assoc. LLP
    Great Neck, New York 11021, United States
  • NY Center for Clinical Research
    Lake Success, New York 11042, United States
  • Mount Sinai School of Medicine IBD Research Center
    New York, New York 10029, United States
  • Asheville Gastroenterology Associates
    Ashville, North Carolina 28801, United States
  • Wake Research Associates
    Raleigh, North Carolina 27612, United States
  • Consultants for Clinical Research
    Cincinnati, Ohio 45219, United States
  • Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
  • Gastrointestinal and Liver Disease Consultants
    Dayton, Ohio 45440, United States
  • Gastroenterology Associates of Cleveland
    Mayfield Heights, Ohio 44124, United States
  • The Oregon Clinic, PC Gastroenterology Division
    Portland, Oregon 97220, United States
  • Regional Gastroenterologist Associates of Lancaster
    Lancaster, Pennsylvania 17604, United States
  • University of Pittsburgh Medical Center
    Pittsburgh, Pennsylvania 15261, United States
  • Columbia Gastro Associates
    Columbia, South Carolina 29204, United States
  • Gastrointestinal Associates
    Knoxville, Tennessee 37909, United States
  • Gastroenterology Center of the Mid South
    Memphis, Tennessee 38120, United States
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
  • Austin Gastroenterology
    Austin, Texas 78745, United States
  • Wasatch Clinical Research
    Salt Lake City, Utah 84107, United States
  • Internal Medicine Associates
    Danville, Virginia 25451, United States
  • Digestive and Liver Disease
    Norfolk, Virginia 23205, United States
  • Spokane Digestive Disease Center
    Spokane, Washington 99204, United States
  • Discovery Research International, LLC
    Milwaukee, Wisconsin 53207, United States
  • Imelda Ziekenhuis
    Bonheiden, 2820, Belgium
  • UZ Gasthuisberg
    Leuven, Belgium
  • Heritage Medical Research Clinic Health Sciences Centre University of Calgary
    Calgary, Alberta T2N 4N1, Canada
  • Liver and Intestinal Disease Research Center
    Vancouver, British Columbia V5Z 1H2, Canada
  • St. Paul's Hospital
    Vancouver, British Columbia V6Z 1Y6, Canada
  • Winnipeg Health Sciences Centre
    Winnipeg, Manitoba R3A 1R9, Canada
  • Queen Elizabeth II Health Sciences Centre
    Halifax, Nova Scotia B3H 1V7, Canada
  • Toronto Digestive Disease Assoc. Inc
    Toronto, Ontario M3N 2V7, Canada
  • Royal Victoria Hospital
    Montreal, Quebec H3A 1A1, Canada
  • Hopital Claude Claude Huriez Hospital
    Lille, Cedex 59037, France
08

References and documents

Publications

  • Sandborn WJ, Rutgeerts P, Enns R, Hanauer SB, Colombel JF, Panaccione R, D'Haens G, Li J, Rosenfeld MR, Kent JD, Pollack PF. Adalimumab induction therapy for Crohn disease previously treated with infliximab: a randomized trial. Ann Intern Med. 2007 Jun 19;146(12):829-38. doi: 10.7326/0003-4819-146-12-200706190-00159. Epub 2007 Apr 30. PubMed 17470824 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00105300
Lead sponsor
Abbott
First posted
Mar 14, 2005
Start date
Oct 2004
Last update
Aug 15, 2006

Study contacts

Global Medical Information 1-800-633-9110
study director · Abbott
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2006. You cannot join it, but the record below documents what was studied.

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