Study of Human Anti-TNF Monoclonal Antibody D2E7 in Subjects With Active Rheumatoid Arthritis
Rheumatoid Arthritis
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion: Subjects must meet ACR criteria for diagnosis of RA for at least 3 months, must meet ACR Functional Class I, II or III (1992 criteria) and must have a confirmed diagnosis of active moderate to severe rheumatoid arthritis as defined by 6 or more swollen joints and 9 or more tender joints; must also have DAS of 3.2 or greater at study entry, normal laboratory parameters and ESR >20, satisfactory response or intolerance to one or more prior DMARDs and be willing and able to give informed consent. Exclusion: Previous treatment with total lymphoid irradiation or anti-CD4 or CAMPATH 1H monoclonal antibodies resulting in persistent CD4 lymphopenia, history of acute inflammatory joint disease other than RA, prior treatment with cyclophosphamide or chlorambucil, prior treatment with intravenous immunoglobulin within 70 days, history of malignant lymphoma, history of uncontrolled diabetes, unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease or stroke, positive HIV status, positive serology for Hepatitis B or C, no previous history of tuberculosis or listeria infection, no previous history of cancer other than successfully treated skin cancer; women can not be pregnant or be breastfeeding
Sites / Locations
- Thomas McGee, MD
- Desert Valley Medical
- Kenneth Hsu, MD, Inc.
- Rheumatology Clinic
- Michael Harrington, MD
- Midori Jane Nishio, MD
- Naveen Raja, MD
- Mountain Rheumatology
- Division of Rheumatic Diseases/University of CT Health Center
- New Haven Medical Group, PC
- Norman Gaylis, MD
- Mike Schweitz, MD
- Maurice McCarthy, MD
- Intermountain Orthopedics
- Institute of Arthritis Research
- Loyola University Medical Center
- West Suburban Health Care
- OSF Medical Group -Rheumatology
- Rockford Clinic, Clinical Research Department
- Pain Therapy Center
- Baton Rouge Clinic
- Thomas Pressly, MD
- Rheumatology Associates
- Northampton Internal Medicine Association
- Fallon Clinic Research
- John Howland, MD
- Freeman Health Systems
- Peggy Schlesinger, MD
- NJ Associates in Medicine
- Internal Medicine and Rheumatic Diseases
- Placido Morano, MD
- NYU Hospital for Joint Disease
- Alan Kaell, MD
- Carolina Bone and Joint, PA
- Gordon Senter, MD Rheumatology, PA
- MedCenter One Health Systems
- University Hospital of Cleveland
- Arthritis Clinic
- STAT Research, Inc.
- Arthritis and Osteoporosis Clinic, LLC
- Jel M. Depper, MD
- Sanford and Roumm Rheumatology
- Frederick Murphy, MD
- Rheumatology Associates
- Rheumatology Associates, Ltd.
- Low Country Research Center
- Medical Specialists of Nashville
- Arthritis and Osteoporosis Clinical Research Center of Central Texas
- Center of Arthritis and Rheumatic Disease, PC
- Margaret Gradzka, MD
- Metropolitan Clinical Research
- Northern Virginia Center for Arthritis
- Lewis-Gale Clinic
- ROAD Clinic