Crohn's Disease Clinical Trial
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
| NCT number | NCT00055523 |
| Other study ID # | M02-403 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | March 4, 2003 |
| Last updated | August 11, 2006 |
| Start date | April 2002 |
| Verified date | August 2006 |
| Source | Abbott |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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)
| 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: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Digestive Disorders Associates | Annapolis | Maryland |
| United States | Northwest Gastroenterologists, S.C. | Arlington Heights | Illinois |
| United States | Atlanta Gastroenterology Assoc. | Atlanta | Georgia |
| United States | Northwest Gastroenterology | Bellevue | Washington |
| United States | Gastroenterology Associates of the East Bay | Berkeley | California |
| United States | Deaconess Billings Clinic Research Division | Billings | Montana |
| United States | Brigham and Women's Hospital | Boston | Massachusetts |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | Gastroenterology Assoc. of Fairfield Co. | Bridgeport | Connecticut |
| United States | UNC School of Medicine | Chapel Hill | North Carolina |
| United States | Carolina Research Associates | Charlotte | North Carolina |
| United States | Charlotte Gastroenterology and Hepatology | Charlotte | North Carolina |
| United States | Charlottesville Medical Research | Charlottesville | Virginia |
| United States | Diseases of the Digestive System | Chattanooga | Tennessee |
| United States | University of Chicago | Chicago | Illinois |
| United States | Consultants for Clinical Research | Cincinnati | Ohio |
| United States | Altoona Center for Clinical Research | Duncansville | Pennsylvania |
| United States | Long Island Clinical Research Associates | Great Neck | New York |
| United States | Gastroenterology and Hepatology | Kansas City | Missouri |
| United States | NY Center for Clinical Research | Lake Success | New York |
| United States | Gastroenterology Specialties, P.C. | Lincoln | Nebraska |
| United States | Long Beach Gastroenterology Assoc. | Long Beach | California |
| United States | Drug Research Services, Inc. | Metairie | Louisiana |
| United States | Glenn Gordon, MD | Mexico | Missouri |
| United States | Wisconsin Center for Advanced Research | Milwaukee | Wisconsin |
| United States | Nashville Medical Research Institute | Nashville | Tennessee |
| United States | LSU School of Medicine | New Orleans | Louisiana |
| United States | Daniel Present | New York | New York |
| United States | New York Presbyterian Hospital | New York | New York |
| United States | Oklahoma Foundation for Digestive Disease | Oklahoma City | Oklahoma |
| United States | Peter Molloy, MD | Pittsburgh | Pennsylvania |
| United States | Wake Research Associates | Raleigh | North Carolina |
| United States | Mayo Clinic and Mayo Foundation | Rochester | Minnesota |
| United States | Rochester Institute for Digestive Diseases | Rochester | New York |
| United States | Sharp Rees-Stealy Medical Group | San Diego | California |
| United States | Southeastern Digestive & Liver Disease | Savannah | Georgia |
| United States | Inland Empire Gastroenterology | Spokane | Washington |
| United States | Tacoma Digestive Disease Center | Tacoma | Washington |
| United States | Research Solutions | Tulsa | Oklahoma |
| United States | Cleveland Clinic Florida | Weston | Florida |
| United States | Digestive Health Specialists | Winston-Salem | North Carolina |
| United States | Shafran Gastroenterology Center | Winter Park | Florida |
| United States | Clinical Pharmacology Study Group | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | comparison of the induction of clinical remission | |||
| Primary | (achievement of a CDAI <150) of adalimumab 40 mg and 80 mg vs. placebo at Week 4. |
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