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:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00055523
First received: March 4, 2003
Last updated: August 11, 2006
Last verified: August 2006
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

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
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 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 by Abbott

Additional 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
Study First Received: March 4, 2003
Last Updated: August 11, 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
Adalimumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on October 01, 2014