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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00077779 |
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Date of registration:
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12/02/2004 |
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Primary sponsor: |
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Public title:
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Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease
CHARM |
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Scientific title:
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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 |
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Date of first enrolment:
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July 2003 |
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Target sample size:
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854 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00077779 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Paul F Pollack, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Abbott |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Crohn's Disease
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Intervention(s)
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Drug: Adalimumab
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Primary Outcome(s)
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Clinical remission (CDAI<150).
[Time Frame: 56 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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