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
| NCT number | NCT00105300 |
| Other study ID # | M04-691 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | March 11, 2005 |
| Last updated | August 13, 2006 |
| Start date | October 2004 |
| Verified date | August 2006 |
| Source | Abbott |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 300 |
| Est. completion date | |
| Est. primary completion date | |
| 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott |
United States, Belgium, Canada, France,
| 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 |
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