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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Induction of clinical remission (CDAI score < 150 at Week 4) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response measured as | ||
| Decrease in Baseline CDAI score >= 70 points at Week 4 | ||
| Decrease in Baseline CDAI score >= 100 points at Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Medical Information 1-800-633-9110 | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Associates | Huntsville | Alabama | 35801 | United States | ||
| Capitol Gastroenterology Consultants Medical Group, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17470824 | Derived | 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. |
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| Changes in IBDQ scores at Week 4 |
| Roseville |
| California |
| 95661 |
| United States |
| Medical Associates Research Group | San Diego | California | 92123 | United States |
| Sharp Rees-Stealy Medical Group | San Diego | California | 92123 | United States |
| SMC-Trauma Research | Englewood | Colorado | 80113 | United States |
| Clinical Research of West Florida, Inc | Clearwater | Florida | 33765 | United States |
| V.A. Medical Center | Gainesville | Florida | 32608 | United States |
| Borland-Groover Clinic | Jacksonville | Florida | 32256 | United States |
| Shafran Gastroenterology Center | Winter Park | Florida | 32789 | United States |
| Pinnacle Trials, Inc. | Atlanta | Georgia | 30329 | United States |
| Atlanta Gastroenterology Assoc. | Atlanta | Georgia | 30342 | United States |
| The University of Chicago | Chicago | Illinois | 60673 | United States |
| Ntouch Research | Peoria | Illinois | 60602 | United States |
| Outpatient Clinical Research Facility University of Indianapolis | Indianapolis | Indiana | 462025250 | United States |
| University of Kentucky Medical Center Division of Digestive Diseases | Lexington | Kentucky | 40536 | United States |
| Drug Research Services, Inc. | Metairie | Louisiana | 70001 | United States |
| Chevy Chase Clinical Research | Chevy Chase | Maryland | 20815 | United States |
| Charm City Research | Towson | Maryland | 21204 | United States |
| Minnesota Gastroenterology P.A. | Plymouth | Minnesota | 55446 | United States |
| Mayo Clinic Research | Rochester | Minnesota | 559050002 | United States |
| Gastrointestinal Associated, P.A. | Jackson | Mississippi | 39202 | United States |
| Glen Gordon, MD | Mexico | Missouri | 65265 | United States |
| St. Louis Center for Clinical Research | St Louis | Missouri | 63128 | United States |
| Atlantic Gastroenterology Associates, LLC | Egg Harbor | New Jersey | 08234 | United States |
| Long Island Clinical Research Assoc. LLP | Great Neck | New York | 11021 | United States |
| NY Center for Clinical Research | Lake Success | New York | 11042 | United States |
| Mount Sinai School of Medicine IBD Research Center | New York | New York | 10029 | United States |
| Asheville Gastroenterology Associates | Ashville | North Carolina | 28801 | United States |
| Wake Research Associates | Raleigh | North Carolina | 27612 | United States |
| Consultants for Clinical Research | Cincinnati | Ohio | 45219 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Gastrointestinal and Liver Disease Consultants | Dayton | Ohio | 45440 | United States |
| Gastroenterology Associates of Cleveland | Mayfield Heights | Ohio | 44124 | United States |
| The Oregon Clinic, PC Gastroenterology Division | Portland | Oregon | 97220 | United States |
| Regional Gastroenterologist Associates of Lancaster | Lancaster | Pennsylvania | 17604 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15261 | United States |
| Columbia Gastro Associates | Columbia | South Carolina | 29204 | United States |
| Gastrointestinal Associates | Knoxville | Tennessee | 37909 | United States |
| Gastroenterology Center of the Mid South | Memphis | Tennessee | 38120 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Austin Gastroenterology | Austin | Texas | 78745 | United States |
| Wasatch Clinical Research | Salt Lake City | Utah | 84107 | United States |
| Internal Medicine Associates | Danville | Virginia | 25451 | United States |
| Digestive and Liver Disease | Norfolk | Virginia | 23205 | United States |
| Spokane Digestive Disease Center | Spokane | Washington | 99204 | United States |
| Discovery Research International, LLC | Milwaukee | Wisconsin | 53207 | United States |
| Imelda Ziekenhuis | Bonheiden | 2820 | Belgium |
| UZ Gasthuisberg | Leuven | Belgium |
| Heritage Medical Research Clinic Health Sciences Centre University of Calgary | Calgary | Alberta | T2N 4N1 | Canada |
| Liver and Intestinal Disease Research Center | Vancouver | British Columbia | V5Z 1H2 | Canada |
| St. Paul's Hospital | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Winnipeg Health Sciences Centre | Winnipeg | Manitoba | R3A 1R9 | Canada |
| Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Toronto Digestive Disease Assoc. Inc | Toronto | Ontario | M3N 2V7 | Canada |
| Royal Victoria Hospital | Montreal | Quebec | H3A 1A1 | Canada |
| Hopital Claude Claude Huriez Hospital | Lille | Cedex | 59037 | France |
| 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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