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Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease (CHARM)

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00077779
First received: February 12, 2004
Last updated: September 23, 2007
Last verified: September 2007

February 12, 2004
September 23, 2007
July 2003
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Clinical remission (CDAI<150). [ Time Frame: 56 weeks ]
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Complete list of historical versions of study NCT00077779 on ClinicalTrials.gov Archive Site
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Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease
A Multi-Center Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease

The purpose of this study is to test whether Adalimumab (at two different doses) can induce and maintain clinical remission in subjects with active Crohn's disease when compared to placebo (a substance containing no medication)

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Crohn's Disease
Drug: Adalimumab
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
854
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Inclusion:

  • Males and females between the ages of 18 and 75 who are diagnosed with moderate to severe Crohn's Disease defined by a CDAI score of >= 220 and <= 450, normal laboratory parameters,
  • are willing and able to give informed consent, and
  • are able to self-inject or have a designee or healthcare professional who can inject the study medication.

Exclusion:

  • History of certain types of cancer, diagnosis of ulcerative colitis,
  • female or breast feeding subjects,
  • surgical bowel resection(s) with in the past 6 months,
  • history of listeria,
  • human immunodeficiency virus (HIV),
  • central nervous system demyelinating disease or untreated TB,
  • history of a poorly controlled medical condition,
  • unsuccessful response to infliximab or any anti-TNF agent use in the past.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00077779
M02-404
Not Provided
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Abbott
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Study Director: Paul F Pollack, M.D. Abbott
Abbott
September 2007

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