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

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.
 
ClinicalTrials.gov Identifier: NCT00077779
Recruitment Status : Completed
First Posted : February 16, 2004
Last Update Posted : September 26, 2007
Sponsor:
Information provided by:
Abbott

Study Description
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Brief Summary:
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)

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Adalimumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 854 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Adalimumab

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Clinical remission (CDAI<150). [ Time Frame: 56 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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

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.
Contacts and Locations
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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): NCT00077779


Locations
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Sponsors and Collaborators
Abbott
Investigators
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Study Director: Paul F Pollack, M.D. Abbott
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00077779    
Other Study ID Numbers: M02-404
First Posted: February 16, 2004    Key Record Dates
Last Update Posted: September 26, 2007
Last Verified: September 2007
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
 Intestinal Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents