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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.
First Received: March 4, 2003   Last Updated: August 11, 2006   History of Changes
Sponsored by: Abbott
Information provided by: Abbott
ClinicalTrials.gov Identifier: NCT00055523
  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 II

Genetics Home Reference related topics: Crohn disease
MedlinePlus related topics: Crohn's Disease
Drug Information available for: Adalimumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
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

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00055523

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

No publications provided

Study ID Numbers: M02-403
Study First Received: March 4, 2003
Last Updated: August 11, 2006
ClinicalTrials.gov Identifier: NCT00055523     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Anti-Inflammatory Agents
Crohn's Disease
Ileitis
Gastrointestinal Diseases
Enteritis
Inflammatory Bowel Diseases
Intestinal Diseases
Adalimumab
Ileal Diseases
Antibodies
Digestive System Diseases
Crohn Disease
Antirheumatic Agents
Gastroenteritis
Immunoglobulins

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Ileitis
Gastrointestinal Diseases
Enteritis
Inflammatory Bowel Diseases
Intestinal Diseases
Adalimumab
Ileal Diseases
Pharmacologic Actions
Digestive System Diseases
Therapeutic Uses
Crohn Disease
Gastroenteritis
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 07, 2009