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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)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab (D2E7) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| comparison of the induction of clinical remission | ||
| (achievement of a CDAI <150) of adalimumab 40 mg and 80 mg vs. placebo at Week 4. |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen B Hanauer, MD | University of Chicago Department of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastroenterology Associates of the East Bay | Berkeley | California | 94705 | United States | ||
| Long Beach Gastroenterology Assoc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22344964 | Derived | Steenholdt C, Al-khalaf M, Brynskov J, Bendtzen K, Thomsen OO, 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. |
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| Long Beach |
| California |
| 90806 |
| United States |
| Sharp Rees-Stealy Medical Group | San Diego | California | 92123 | United States |
| Gastroenterology Assoc. of Fairfield Co. | Bridgeport | Connecticut | 06606 | United States |
| Cleveland Clinic Florida | Weston | Florida | 33331 | United States |
| Shafran Gastroenterology Center | Winter Park | Florida | 32789 | United States |
| Atlanta Gastroenterology Assoc. | Atlanta | Georgia | 30342 | United States |
| Southeastern Digestive & Liver Disease | Savannah | Georgia | 31404 | United States |
| Northwest Gastroenterologists, S.C. | Arlington Heights | Illinois | 600005 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Drug Research Services, Inc. | Metairie | Louisiana | 70001 | United States |
| LSU School of Medicine | New Orleans | Louisiana | 70115 | United States |
| Digestive Disorders Associates | Annapolis | Maryland | 21401 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 002115 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Clinical Pharmacology Study Group | Worcester | Massachusetts | 01610 | United States |
| Mayo Clinic and Mayo Foundation | Rochester | Minnesota | 55905 | United States |
| Gastroenterology and Hepatology | Kansas City | Missouri | 64131 | United States |
| Glenn Gordon, MD | Mexico | Missouri | 65265 | United States |
| Deaconess Billings Clinic Research Division | Billings | Montana | 59101 | United States |
| Gastroenterology Specialties, P.C. | Lincoln | Nebraska | 68503 | United States |
| Long Island Clinical Research Associates | Great Neck | New York | 11021 | United States |
| NY Center for Clinical Research | Lake Success | New York | 11042 | United States |
| New York Presbyterian Hospital | New York | New York | 10021 | United States |
| Daniel Present | New York | New York | 10029 | United States |
| Rochester Institute for Digestive Diseases | Rochester | New York | 14607 | United States |
| UNC School of Medicine | Chapel Hill | North Carolina | 27599 | United States |
| Charlotte Gastroenterology and Hepatology | Charlotte | North Carolina | 28207 | United States |
| Carolina Research Associates | Charlotte | North Carolina | 28262 | United States |
| Wake Research Associates | Raleigh | North Carolina | 27612 | United States |
| Digestive Health Specialists | Winston-Salem | North Carolina | 27103 | United States |
| Consultants for Clinical Research | Cincinnati | Ohio | 45219 | United States |
| Oklahoma Foundation for Digestive Disease | Oklahoma City | Oklahoma | 73104 | United States |
| Research Solutions | Tulsa | Oklahoma | 74104 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Peter Molloy, MD | Pittsburgh | Pennsylvania | 15224 | United States |
| Diseases of the Digestive System | Chattanooga | Tennessee | 37421 | United States |
| Nashville Medical Research Institute | Nashville | Tennessee | 37205 | United States |
| Charlottesville Medical Research | Charlottesville | Virginia | 22902 | United States |
| Northwest Gastroenterology | Bellevue | Washington | 98004 | United States |
| Inland Empire Gastroenterology | Spokane | Washington | 99204 | United States |
| Tacoma Digestive Disease Center | Tacoma | Washington | 98405 | United States |
| Wisconsin Center for Advanced Research | Milwaukee | Wisconsin | 53702 | United States |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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