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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Crohn's Disease | Drug: Adalimumab | Phase 3 |
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 |

- Clinical remission (CDAI<150). [ Time Frame: 56 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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

Study Director: | Paul F Pollack, M.D. | Abbott |
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 |
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
Intestinal Diseases Adalimumab Anti-Inflammatory Agents Antirheumatic Agents |