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The purpose of this study is to test whether Adalimumab (at two different doses) can induce and maintain clinical remission in subjects with active Crohn's disease when compared to placebo (a substance containing no medication)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical remission (CDAI<150). | 56 weeks |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Paul F Pollack, M.D. | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thornton Hospital Reumatology Division | La Jolla | California | 92037-0943 | United States | ||
| UCSF San Francisco General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34546360 | Derived | Sandborn WJ, Lewis JD, Panes J, Loftus EV, D'Haens G, Yu Z, Huang B, Lacerda AP, Pangan AL, Feagan BG. Association Between Proposed Definitions of Clinical Remission/Response and Well-Being in Patients With Crohn's Disease. J Crohns Colitis. 2022 Mar 14;16(3):444-451. doi: 10.1093/ecco-jcc/jjab161. | |
| 29380251 | Derived |
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| San Francisco |
| California |
| 94110 |
| United States |
| Cal-West, Inc. | San Francisco | California | 94117 | United States |
| Western States Clinical Research | Arvada | Colorado | 80002 | United States |
| Gastroenterology Associates of Fairfield County | Bridgeport | Connecticut | 06606 | United States |
| Clinical Research of West Florida, Inc. | Clearwater | Florida | 33765 | United States |
| V.A. Medical Center | Gainsville | Florida | 32608 | United States |
| Mark Lamet, MD | Hollywood | Florida | 33021 | United States |
| Gastroenterology Consultants | Ormond Beach | Florida | 32174 | United States |
| Northwest Gastroenterology | Arlington Heights | Illinois | 60005 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| The University of Chicago | Chicago | Illinois | 60637 | United States |
| Indianapolis Gastroenterology Research Foundation | Indianapolis | Indiana | 46237 | United States |
| St. Vincent Hospital: Research Department | Indianapolis | Indiana | 46260 | United States |
| Drug Research Services, Inc. | Metairie | Louisiana | 70001 | United States |
| Maryland Clinical Trials | Annapolis | Maryland | 21401 | United States |
| Chevy Chase Clinical Research | Chevy Chase | Maryland | 20815 | United States |
| Capital Gastroenterology Consultants, P.A. | Silver Spring | Maryland | 20901 | United States |
| Clinical Pharmacology Study Group | Worcester | Massachusetts | 01610 | United States |
| Mayo Clinic Research | Rochester | Minnesota | 55905-0002 | United States |
| Gastroenterology & Hematology | Kansas City | Missouri | 64131 | United States |
| Glenn Gordon, MD | Mexico | Missouri | 65265 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Washington University School | St Louis | Missouri | 63110 | United States |
| Long Island Clinical Research Assoc. | Great Neck | New York | 11021 | United States |
| NY Center for Clinical Research | Lake Success | New York | 11042 | United States |
| Daniel Present, MD | New York | New York | 10029 | United States |
| Digestive Disease Associates of Rockland | Pomona | New York | 10970 | United States |
| Charlotte Gastroenterology & Hepatology | Charlotte | North Carolina | 28207 | United States |
| Carolina Digestive Health Associates | Charlotte | North Carolina | 28211 | United States |
| Carolina Research Associates | Charlotte | North Carolina | 28262 | United States |
| Le Bauer Research, P.A. | Greensboro | North Carolina | 27403 | United States |
| Wilmington Gastroenterology | Wilmington | North Carolina | 28401 | United States |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | United States |
| Westhills Gastroenterology | Portland | Oregon | 98112 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15261 | United States |
| Columbia Gastro Associates | Columbia | South Carolina | 29204 | United States |
| Gastroenterology Center of the Mid South | Memphis | Tennessee | 38120 | United States |
| Nashville Medical Research | Nashville | Tennessee | 37205 | United States |
| Gastrointestinal Specialists | Richmond | Virginia | 23230 | United States |
| Discovery Research Inteternational, LLC | Milwaukee | Wisconsin | 53215 | United States |
| Wisconsin Center for Advanced Research | Milwaukee | Wisconsin | 53215 | United States |
| Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6. |
| 24134498 | Derived | Panaccione R, Colombel JF, Sandborn WJ, D'Haens G, Zhou Q, Pollack PF, Thakkar RB, Robinson AM. Adalimumab maintains remission of Crohn's disease after up to 4 years of treatment: data from CHARM and ADHERE. Aliment Pharmacol Ther. 2013 Nov;38(10):1236-47. doi: 10.1111/apt.12499. Epub 2013 Sep 22. |
| 22704916 | Derived | Schreiber S, Reinisch W, Colombel JF, Sandborn WJ, Hommes DW, Robinson AM, Huang B, Lomax KG, Pollack PF. Subgroup analysis of the placebo-controlled CHARM trial: increased remission rates through 3 years for adalimumab-treated patients with early Crohn's disease. J Crohns Colitis. 2013 Apr;7(3):213-21. doi: 10.1016/j.crohns.2012.05.015. Epub 2012 Jun 16. |
| 21645018 | Derived | Kamm MA, Hanauer SB, Panaccione R, Colombel JF, Sandborn WJ, Pollack PF, Zhou Q, Robinson AM. Adalimumab sustains steroid-free remission after 3 years of therapy for Crohn's disease. Aliment Pharmacol Ther. 2011 Aug;34(3):306-17. doi: 10.1111/j.1365-2036.2011.04717.x. Epub 2011 Jun 5. |
| 19201775 | Derived | Colombel JF, Schwartz DA, Sandborn WJ, Kamm MA, D'Haens G, Rutgeerts P, Enns R, Panaccione R, Schreiber S, Li J, Kent JD, Lomax KG, Pollack PF. Adalimumab for the treatment of fistulas in patients with Crohn's disease. Gut. 2009 Jul;58(7):940-8. doi: 10.1136/gut.2008.159251. Epub 2009 Feb 6. |
| 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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