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

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00105300
• Other study ID #: M04-691
• Status: Completed
• Phase: Phase 3
• First received: March 11, 2005
• Last updated: August 13, 2006
• Start date: October 2004

Study information

• Verified date: August 2006
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Adalimumab

Locations

Country	Name	City	State
Belgium	Imelda Ziekenhuis	Bonheiden
Belgium	UZ Gasthuisberg	Leuven
Canada	Heritage Medical Research Clinic Health Sciences Centre University of Calgary	Calgary	Alberta
Canada	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia
Canada	Royal Victoria Hospital	Montreal	Quebec
Canada	Toronto Digestive Disease Assoc. Inc	Toronto	Ontario
Canada	Liver and Intestinal Disease Research Center	Vancouver	British Columbia
Canada	St. Paul’s Hospital	Vancouver	British Columbia
Canada	Winnipeg Health Sciences Centre	Winnipeg	Manitoba
France	Hopital Claude Claude Huriez Hospital	Lille	Cedex
United States	Asheville Gastroenterology Associates	Ashville	North Carolina
United States	Atlanta Gastroenterology Assoc.	Atlanta	Georgia
United States	Pinnacle Trials, Inc.	Atlanta	Georgia
United States	Austin Gastroenterology	Austin	Texas
United States	Chevy Chase Clinical Research	Chevy Chase	Maryland
United States	The University of Chicago	Chicago	Illinois
United States	Consultants for Clinical Research	Cincinnati	Ohio
United States	Clinical Research of West Florida, Inc	Clearwater	Florida
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Columbia Gastro Associates	Columbia	South Carolina
United States	Internal Medicine Associates	Danville	Virginia
United States	Gastrointestinal and Liver Disease Consultants	Dayton	Ohio
United States	Atlantic Gastroenterology Associates, LLC	Egg Harbor Township	New Jersey
United States	SMC-Trauma Research	Englewood	Colorado
United States	V.A. Medical Center	Gainesville	Florida
United States	Long Island Clinical Research Assoc. LLP	Great Neck	New York
United States	Clinical Research Associates	Huntsville	Alabama
United States	Outpatient Clinical Research Facility University of Indianapolis	Indianapolis	Indiana
United States	Gastrointestinal Associated, P.A.	Jackson	Mississippi
United States	Borland-Groover Clinic	Jacksonville	Florida
United States	Gastrointestinal Associates	Knoxville	Tennessee
United States	NY Center for Clinical Research	Lake Success	New York
United States	Regional Gastroenterologist Associates of Lancaster	Lancaster	Pennsylvania
United States	University of Kentucky Medical Center Division of Digestive Diseases	Lexington	Kentucky
United States	Gastroenterology Associates of Cleveland	Mayfield Heights	Ohio
United States	Gastroenterology Center of the Mid South	Memphis	Tennessee
United States	Drug Research Services, Inc.	Metairie	Louisiana
United States	Glen Gordon, MD	Mexico	Missouri
United States	Discovery Research International, LLC	Milwaukee	Wisconsin
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Mount Sinai School of Medicine IBD Research Center	New York	New York
United States	Digestive and Liver Disease	Norfolk	Virginia
United States	Ntouch Research	Peoria	Illinois
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Minnesota Gastroenterology P.A.	Plymouth	Minnesota
United States	The Oregon Clinic, PC Gastroenterology Division	Portland	Oregon
United States	Wake Research Associates	Raleigh	North Carolina
United States	Mayo Clinic Research	Rochester	Minnesota
United States	Capitol Gastroenterology Consultants Medical Group, Inc.	Roseville	California
United States	Wasatch Clinical Research	Salt Lake City	Utah
United States	Medical Associates Research Group	San Diego	California
United States	Sharp Rees-Stealy Medical Group	San Diego	California
United States	Spokane Digestive Disease Center	Spokane	Washington
United States	St. Louis Center for Clinical Research	St. Louis	Missouri
United States	Charm City Research	Towson	Maryland
United States	Shafran Gastroenterology Center	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Induction of clinical remission (CDAI score < 150 at Week 4)
Secondary	Clinical response measured as
Secondary	Decrease in Baseline CDAI score >= 70 points at Week 4
Secondary	Decrease in Baseline CDAI score >= 100 points at Week 4
Secondary	Changes in IBDQ scores at Week 4