Clinical trial NCT00105300: Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2005-03-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Induction of clinical remission (CDAI score < 150 at Week 4)
Secondary outcomes:
measure: Clinical response measured as
measure: Decrease in Baseline CDAI score >= 70 points at Week 4
measure: Decrease in Baseline CDAI score >= 100 points at Week 4
measure: Changes in IBDQ scores at Week 4
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Clinical Research Associates
state: Alabama
city: Roseville
country: United States
facility: Capitol Gastroenterology Consultants Medical Group, Inc.
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group
state: California
city: San Diego
country: United States
facility: Sharp Rees-Stealy Medical Group
state: California
city: Englewood
country: United States
facility: SMC-Trauma Research
state: Colorado
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc
state: Florida
city: Gainesville
country: United States
facility: V.A. Medical Center
state: Florida
city: Jacksonville
country: United States
facility: Borland-Groover Clinic
state: Florida
city: Winter Park
country: United States
facility: Shafran Gastroenterology Center
state: Florida
city: Atlanta
country: United States
facility: Pinnacle Trials, Inc.
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Assoc.
state: Georgia
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Peoria
country: United States
facility: Ntouch Research
state: Illinois
city: Indianapolis
country: United States
facility: Outpatient Clinical Research Facility University of Indianapolis
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky Medical Center Division of Digestive Diseases
state: Kentucky
city: Metairie
country: United States
facility: Drug Research Services, Inc.
state: Louisiana
city: Chevy Chase
country: United States
facility: Chevy Chase Clinical Research
state: Maryland
city: Towson
country: United States
facility: Charm City Research
state: Maryland
city: Plymouth
country: United States
facility: Minnesota Gastroenterology P.A.
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Research
state: Minnesota
city: Jackson
country: United States
facility: Gastrointestinal Associated, P.A.
state: Mississippi
city: Mexico
country: United States
facility: Glen Gordon, MD
state: Missouri
city: St. Louis
country: United States
facility: St. Louis Center for Clinical Research
state: Missouri
city: Egg Harbor Township
country: United States
facility: Atlantic Gastroenterology Associates, LLC
state: New Jersey
city: Great Neck
country: United States
facility: Long Island Clinical Research Assoc. LLP
state: New York
city: Lake Success
country: United States
facility: NY Center for Clinical Research
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine IBD Research Center
state: New York
city: Ashville
country: United States
facility: Asheville Gastroenterology Associates
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Dayton
country: United States
facility: Gastrointestinal and Liver Disease Consultants
state: Ohio
city: Mayfield Heights
country: United States
facility: Gastroenterology Associates of Cleveland
state: Ohio
city: Portland
country: United States
facility: The Oregon Clinic, PC Gastroenterology Division
state: Oregon
city: Lancaster
country: United States
facility: Regional Gastroenterologist Associates of Lancaster
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Columbia
country: United States
facility: Columbia Gastro Associates
state: South Carolina
city: Knoxville
country: United States
facility: Gastrointestinal Associates
state: Tennessee
city: Memphis
country: United States
facility: Gastroenterology Center of the Mid South
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Austin Gastroenterology
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research
state: Utah
city: Danville
country: United States
facility: Internal Medicine Associates
state: Virginia
city: Norfolk
country: United States
facility: Digestive and Liver Disease
state: Virginia
city: Spokane
country: United States
facility: Spokane Digestive Disease Center
state: Washington
city: Milwaukee
country: United States
facility: Discovery Research International, LLC
state: Wisconsin
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
city: Calgary
country: Canada
facility: Heritage Medical Research Clinic Health Sciences Centre University of Calgary
state: Alberta
city: Vancouver
country: Canada
facility: Liver and Intestinal Disease Research Center
state: British Columbia
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: Winnipeg Health Sciences Centre
state: Manitoba
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Toronto
country: Canada
facility: Toronto Digestive Disease Assoc. Inc
state: Ontario
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
city: Lille
country: France
facility: Hopital Claude Claude Huriez Hospital
state: Cedex
Study officials:
affiliation: Abbott
name: Global Medical Information 1-800-633-9110
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.7326/0003-4819-146-12-200706190-00159. Epub 2007 Apr 30.