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

This study has been completed.

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00055523

Purpose

Purpose of the study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease when compared to placebo (an inactive substance)

Condition	Intervention	Phase
Crohn's Disease	Drug: Adalimumab (D2E7)	Phase II

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Adalimumab Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease

Further study details as provided by Abbott:

Primary Outcome Measures:

comparison of the induction of clinical remission
(achievement of a CDAI <150) of adalimumab 40 mg and 80 mg vs. placebo at Week 4.

Estimated Enrollment:	300
Study Start Date:	April 2002

Eligibility

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

Criteria

Inclusion:

Diagnosis of Crohn's disease
CDAI score at baseline of between 220 and 450
Normal laboratory parameters
Willing and able to give informed consent

Exclusion:

Diagnosis of ulcerative colitis
Women cannot be pregnant or breastfeeding
No previous use of infliximab or other anti-TNF antagonists
No previous history of tuberculosis or listeria infection
No previous history of cancer other than successfully treated skin cancer

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00055523

Show 43 Study Locations

Sponsors and Collaborators

Abbott

Investigators

Principal Investigator:

Stephen B Hanauer, MD

University of Chicago Department of Medicine

More Information

Study ID Numbers:	M02-403
Study First Received:	March 4, 2003
Last Updated:	August 11, 2006
ClinicalTrials.gov Identifier:	NCT00055523
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antibodies
Digestive System Diseases
Gastrointestinal Diseases
Crohn Disease
Inflammatory Bowel Diseases

Adalimumab
Gastroenteritis
Intestinal Diseases
Immunoglobulins

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009