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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:
Abbott
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00077779
First received: February 12, 2004
Last updated: September 23, 2007
Last verified: September 2007
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Crohn's Disease | Drug: Adalimumab | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Crohn disease
MedlinePlus related topics:
Crohn's Disease
Drug Information available for:
Adalimumab
U.S. FDA Resources
Further study details as provided by Abbott:
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| 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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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: NCT00077779
Show 43 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00077779
Show 43 Study Locations
Sponsors and Collaborators
Abbott
Investigators
| Study Director: | Paul F Pollack, M.D. | Abbott |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00077779 History of Changes |
| Other Study ID Numbers: |
M02-404 |
| Study First Received: | February 12, 2004 |
| Last Updated: | September 23, 2007 |
Additional relevant MeSH terms:
|
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
Intestinal Diseases Adalimumab Anti-Inflammatory Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on June 23, 2017