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.

Sponsor:

Information provided by:

Abbott

ClinicalTrials.gov Identifier:

NCT00055523

First received: March 4, 2003

Last updated: August 11, 2006

Last verified: August 2006

History of Changes

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 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment
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

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:

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

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, see Learn About Clinical Studies.

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

No publications provided by Abbott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Steenholdt C, Al-khalaf M, Brynskov J, Bendtzen K, Thomsen OØ, Ainsworth MA. Clinical implications of variations in anti-infliximab antibody levels in patients with inflammatory bowel disease. Inflamm Bowel Dis. 2012 Dec;18(12):2209-17. doi: 10.1002/ibd.22910. Epub 2012 Feb 16.


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

Additional relevant MeSH terms:


Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases	Adalimumab Anti-Inflammatory Agents Antirheumatic Agents Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

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