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

This study has been completed.
Information provided by:
Abbott Identifier:
First received: March 11, 2005
Last updated: August 13, 2006
Last verified: August 2006
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.

Condition Intervention Phase
Crohn's Disease
Drug: Adalimumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Induction of clinical remission (CDAI score < 150 at Week 4)

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 300
Study Start Date: October 2004

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00105300

  Show 56 Study Locations
Sponsors and Collaborators
Study Director: Global Medical Information 1-800-633-9110 Abbott
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00105300     History of Changes
Other Study ID Numbers: M04-691
Study First Received: March 11, 2005
Last Updated: August 13, 2006

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on May 25, 2017