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

March 4, 2003
August 11, 2006
April 2002
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  • comparison of the induction of clinical remission
  • (achievement of a CDAI <150) of adalimumab 40 mg and 80 mg vs. placebo at Week 4.
Not Provided
Complete list of historical versions of study NCT00055523 on ClinicalTrials.gov Archive Site
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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
A Phase II Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease

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)

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Crohn's Disease
Drug: Adalimumab (D2E7)
Not Provided
Steenholdt C, Al-khalaf M, Brynskov J, Bendtzen K, Thomsen OØ, Ainsworth MA. Clinical implications of variations in anti-infliximab antibody levels in patients with inflammatory bowel disease. Inflamm Bowel Dis. 2012 Dec;18(12):2209-17. doi: 10.1002/ibd.22910. Epub 2012 Feb 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
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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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00055523
M02-403
Not Provided
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Abbott
Not Provided
Principal Investigator: Stephen B Hanauer, MD University of Chicago Department of Medicine
Abbott
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP