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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.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00105300
First received: March 11, 2005
Last updated: August 13, 2006
Last verified: August 2006
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Adalimumab
U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00105300

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

No publications provided by Abbott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00105300     History of Changes
Other Study ID Numbers: M04-691
Study First Received: March 11, 2005
Last Updated: August 13, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Antibodies, Monoclonal
 Adalimumab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on June 17, 2013