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| Sponsor: | Abbott |
|---|---|
| Information provided by: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00049751 |
Purpose
The purpose of the study is to evaluate safety by collecting serious adverse events in subjects with moderately to severely active rheumatoid arthritis who are unable to obtain etanercept and who have failed one or more prior disease-modifying antirheumatic drugs (DMARDs).
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: Adalimumab |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Multicenter Study of the Safety of Human Anti-TNF Monoclonal Antibody D2E7 in Subjects With Active Rheumatoid Arthritis |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Thomas McGee, MD | |
| Mobile, Alabama, United States | |
| United States, California | |
| Naveen Raja, MD | |
| Whittier,, California, United States | |
| Rheumatology Clinic | |
| Los Angeles, California, United States | |
| Michael Harrington, MD | |
| Napa, California, United States | |
| Desert Valley Medical | |
| Apple Valley, California, United States | |
| Midori Jane Nishio, MD | |
| Walnut Creek, California, United States | |
| Kenneth Hsu, MD, Inc. | |
| Bakersfield, California, United States | |
| United States, Colorado | |
| Mountain Rheumatology | |
| Denver, Colorado, United States | |
| United States, Connecticut | |
| Division of Rheumatic Diseases/University of CT Health Center | |
| Farmington,, Connecticut, United States | |
| New Haven Medical Group, PC | |
| New Haven, Connecticut, United States | |
| United States, Florida | |
| Norman Gaylis, MD | |
| Aventura,, Florida, United States | |
| Mike Schweitz, MD | |
| West Palm Beach, Florida, United States | |
| Maurice McCarthy, MD | |
| Winter Haven,, Florida, United States | |
| United States, Idaho | |
| Institute of Arthritis Research | |
| Idaho Falls,, Idaho, United States | |
| Intermountain Orthopedics | |
| Boise, Idaho, United States | |
| Intermountain Orthopedics | |
| Boise, Idaho, United States | |
| United States, Illinois | |
| OSF Medical Group -Rheumatology | |
| Peoria, Illinois, United States | |
| West Suburban Health Care | |
| Oak Park, Illinois, United States | |
| Rockford Clinic, Clinical Research Department | |
| Rockton, Illinois, United States | |
| Loyola University Medical Center | |
| Maywood, Illinois, United States | |
| Pain Therapy Center | |
| Schaumburg, Illinois, United States | |
| United States, Louisiana | |
| Baton Rouge Clinic | |
| Baton Rouge, Louisiana, United States | |
| Thomas Pressly, MD | |
| Shreveport, Louisiana, United States | |
| United States, Maine | |
| Rheumatology Associates | |
| Portland, Maine, United States | |
| United States, Massachusetts | |
| Northampton Internal Medicine Association | |
| Northampton, Massachusetts, United States | |
| Fallon Clinic Research | |
| West Boylston, Massachusetts, United States | |
| United States, Michigan | |
| John Howland, MD | |
| Bay City, Michigan, United States | |
| United States, Missouri | |
| Freeman Health Systems | |
| Joplin, Missouri, United States | |
| United States, Montana | |
| Peggy Schlesinger, MD | |
| Missoula, Montana, United States | |
| United States, New Jersey | |
| NJ Associates in Medicine | |
| Fair Lawn, New Jersey, United States | |
| Internal Medicine and Rheumatic Diseases | |
| Millburn, New Jersey, United States | |
| United States, New York | |
| NYU Hospital for Joint Disease | |
| New York, New York, United States | |
| Placido Morano, MD | |
| Brooklyn, New York, United States | |
| Alan Kaell, MD | |
| Port Jefferson Station, New York, United States | |
| United States, North Carolina | |
| Gordon Senter, MD Rheumatology, PA | |
| Salisbury, North Carolina, United States | |
| Carolina Bone and Joint, PA | |
| Monroe, North Carolina, United States | |
| United States, North Dakota | |
| MedCenter One Health Systems | |
| Bismarck, North Dakota, United States | |
| United States, Ohio | |
| University Hospital of Cleveland | |
| Beachwood, Ohio, United States | |
| Arthritis Clinic | |
| Canton, Ohio, United States | |
| STAT Research, Inc. | |
| Dayton, Ohio, United States | |
| United States, Oregon | |
| Jel M. Depper, MD | |
| Bend, Oregon, United States | |
| Arthritis and Osteoporosis Clinic, LLC | |
| Bend, Oregon, United States | |
| United States, Pennsylvania | |
| Rheumatology Associates | |
| Norristown, Pennsylvania, United States | |
| Frederick Murphy, MD | |
| Duncansville,, Pennsylvania, United States | |
| Sanford and Roumm Rheumatology | |
| Camp Hill, Pennsylvania, United States | |
| Rheumatology Associates, Ltd. | |
| Sellersville, Pennsylvania, United States | |
| United States, South Carolina | |
| Low Country Research Center | |
| N. Charleston,, South Carolina, United States | |
| United States, Tennessee | |
| Medical Specialists of Nashville | |
| Nashville, Tennessee, United States | |
| United States, Texas | |
| Arthritis and Osteoporosis Clinical Research Center of Central Texas | |
| Waco, Texas, United States | |
| United States, Virginia | |
| Lewis-Gale Clinic | |
| Salem, Virginia, United States | |
| Metropolitan Clinical Research | |
| Falls Church, Virginia, United States | |
| Margaret Gradzka, MD | |
| Fairfax, Virginia, United States | |
| Center of Arthritis and Rheumatic Disease, PC | |
| Chesapeake, Virginia, United States | |
| Northern Virginia Center for Arthritis | |
| Reston, Virginia, United States | |
| United States, Washington | |
| ROAD Clinic | |
| Lakewood, Washington, United States | |
| Principal Investigator: | William M. Edwards, M.D. | Low Country Research Center, North Charelston SC |
More Information
| Study ID Numbers: | M02-498 |
| Study First Received: | November 13, 2002 |
| Last Updated: | August 13, 2006 |
| ClinicalTrials.gov Identifier: | NCT00049751 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Anti-Inflammatory Agents Autoimmune Diseases Immune System Diseases Immunologic Factors Joint Diseases Physiological Effects of Drugs Arthritis, Rheumatoid Rheumatic Diseases |
Adalimumab Pharmacologic Actions Antibodies, Monoclonal Musculoskeletal Diseases Therapeutic Uses Arthritis Connective Tissue Diseases Antirheumatic Agents |