Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease - Full Text View

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00105300

Purpose

The goal of this study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease who have been initially treated with infliximab and either lost response or discontinued its use as a result of intolerance to the drug.

Condition	Intervention	Phase
Crohn's Disease	Drug: Adalimumab	Phase III

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Adalimumab Immunoglobulins Globulin, Immune Infliximab

U.S. FDA Resources

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 of Clinical Remission in Subjects With Moderate to Severe Crohn's Disease Who Have Lost Response or Are Intolerant to Infliximab

Further study details as provided by Abbott:

Primary Outcome Measures:

Induction of clinical remission (CDAI score < 150 at Week 4)

Secondary Outcome Measures:

Clinical response measured as
Decrease in Baseline CDAI score >= 70 points at Week 4
Decrease in Baseline CDAI score >= 100 points at Week 4
Changes in IBDQ scores at Week 4

Estimated Enrollment:	300
Study Start Date:	October 2004

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males and females between the ages of 18 and 75 who are diagnosed with mild to moderate Crohn's disease (defined by a CDAI [Crohn's Disease Activity Index] score of 220 and 450)
Normal lab parameters
Are willing to give informed consent
Have previously used and either were intolerant to or lost response to infliximab

Exclusion Criteria:

History of certain types of cancer
Diagnosis of ulcerative colitis
Pregnant female or breast feeding subjects
Known obstructive strictures
Surgical bowel resection in the past 6 months
History of listeria, human immunodeficiency virus (HIV), central nervous system demyelinating disease or untreated TB (tuberculosis)
History of poorly controlled medical conditions
Specific doses and durations of Crohn's medications
Subjects that have previously used infliximab and have never clinically responded unless primary non-response was due to a treatment limiting reaction to infliximab

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00105300

Show 56 Study Locations

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Global Medical Information 1-800-633-9110

Abbott

More Information

Publications indexed to this study:

Sandborn WJ, Rutgeerts P, Enns R, Hanauer SB, Colombel JF, Panaccione R, D'Haens G, Li J, Rosenfeld MR, Kent JD, Pollack PF. Adalimumab induction therapy for crohn disease previously treated with infliximab: a randomized trial. Ann Intern Med. 2007 Jun 19;146(12):829-38. Epub 2007 Apr 30.

Study ID Numbers:	M04-691
Study First Received:	March 11, 2005
Last Updated:	August 13, 2006
ClinicalTrials.gov Identifier:	NCT00105300
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antibodies, Monoclonal
Antibodies
Digestive System Diseases
Infliximab
Gastrointestinal Diseases
Crohn Disease

Inflammatory Bowel Diseases
Adalimumab
Gastroenteritis
Intestinal Diseases
Immunoglobulins

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Therapeutic Uses

Physiological Effects of Drugs
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009