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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00055523
First Posted: March 6, 2003
Last Update Posted: August 15, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Abbott
  Purpose
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)

Condition Intervention Phase
Crohn's Disease Drug: Adalimumab (D2E7) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase II Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Abbott:

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

Estimated Enrollment: 300
Study Start Date: April 2002
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00055523


  Show 43 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Principal Investigator: Stephen B Hanauer, MD University of Chicago Department of Medicine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00055523     History of Changes
Other Study ID Numbers: M02-403
First Submitted: March 4, 2003
First Posted: March 6, 2003
Last Update Posted: August 15, 2006
Last Verified: August 2006

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