Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease - Full Text View

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

This study has been completed.

First Received: February 12, 2004 Last Updated: September 23, 2007 History of Changes

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00077779

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

Primary Outcome Measures:

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

Enrollment:	854
Study Start Date:	July 2003

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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

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

No publications provided by Abbott

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Colombel JF, Schwartz DA, Sandborn WJ, Kamm MA, D'Haens G, Rutgeerts P, Enns R, Panaccione R, Schreiber S, Li J, Kent JD, Lomax KG, Pollack PF. Adalimumab for the treatment of fistulas in patients with Crohn's disease. Gut. 2009 Jul;58(7):940-8. Epub 2009 Feb 6.

Study ID Numbers:	M02-404
Study First Received:	February 12, 2004
Last Updated:	September 23, 2007
ClinicalTrials.gov Identifier:	NCT00077779 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anti-Inflammatory Agents
Crohn's Disease
Ileitis
Gastrointestinal Diseases
Enteritis
Inflammatory Bowel Diseases
Intestinal Diseases
Adalimumab

Ileal Diseases
Antibodies, Monoclonal
Antibodies
Digestive System Diseases
Crohn Disease
Antirheumatic Agents
Gastroenteritis
Immunoglobulins

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Ileitis
Gastrointestinal Diseases
Enteritis
Inflammatory Bowel Diseases
Intestinal Diseases
Adalimumab

Ileal Diseases
Pharmacologic Actions
Digestive System Diseases
Therapeutic Uses
Crohn Disease
Gastroenteritis
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 30, 2009