Safety and Efficacy of a Monoclonal Antibody for Treatment of Rheumatoid Arthritis.
Rheumatoid Arthritis
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion criteria: Clinical diagnosis of moderate to severe rheumatoid arthritis. On stable dose of methotrexate. 18 to 80 years of age. Less than 275 lbs. Exclusion criteria: Joint replacement surgery within 60 days of the start of drug dosing. Intra-articular cortisone injections within 28 days of the start of drug dosing. Pregnancy. History of severe allergic or anaphylactic reactions. Active bacterial, viral, fungal, mycobacterium tuberculosis. Positive PPD test. History of any opportunistic infection. Serious persisting local or systemic infection. History of malignancy within the past five years. Received any vaccine within 28 days of the start of study drug dosing. Joint replacement therapy planned within nine months of the start of study drug dosing. Chronic disorders apart from RA affecting the joints. Significant systemic involvement secondary to RA. COPD, asthma, or other pulmonary disease. Received any DMARD other than methotrexate in the 28 days prior to the start of study drug dosing. Approved biologic RA therapy during the 28 days or 7 half-lives of the drug prior to the start of drug dosing. Investigational drug and/or treatment during the 28 days or seven half-lives of the investigational drug prior to the start of study drug dosing. Liver disease or abnormal hepatic function. Serum creatinine level > 1.5 mg/dL. Platelet count < 125,000 cells/mm3. WBC count < 3,500 cells/mm3. Seropositive for hepatitis B surface antigen. Seropositive for hepatitis C antibody. Known seropositivity for HIV.
Sites / Locations
- University of Alabama at Birmingham
- Rheumatology Associates of North Alabama
- Arizona Arthritis Research, PLC
- Advanced Clinical Therapeutics, LLC
- NEA Clinic
- Little Rock Diagnostic Clinic
- University of California at San Diego
- UCLA
- Wallace Rheumatic Study Center
- Boling Clinical Trials
- Desert Medical Advances
- The San Diego Arthritis and Osteoporosis Medical Clinic
- Pacific Arthritis Center
- Northeast Clinical Research, LLC
- Clinical Research Consultants, Inc.
- Clinical Research of West Florida
- The Center for Rheumatology, Immunology and Arthritis
- Anchor Research Center
- Rheumatology Associates of Central Florida
- nTouch Research Corporation
- Tampa Medical Group
- nTouch Research Corporation
- Palm Beach Research Center
- nTouch Research Corporation
- nTouch Research Corporation
- Tri-State Arthritis and Rheumatology Center, LLC
- Central Iowa Hospital Corporation
- Beth Israel Deaconess Medical Center
- Phase III Clinical Research
- The Center for Pharmaceutical Research
- Washington University Center for Clinical Studies
- Clinical Research Center of Nevada
- Albert Einstein College of Medicine
- State University of New York Health Science Center at Brooklyn
- Bassett Healthcare Clinical Pharmacology Research Center
- Long Island Jewish Medical Center
- Hospital for Joint Disease, ACRC
- Mount Sinai School of Medicine
- Prem C. Chatpar, M.D.
- State University of New York Upstate Medical University
- McBride Clinic, Inc.
- Altoona Center for Clinical Research
- nTouch Research Corporation
- Rheumatic Disease Associates
- Volunteer Research Group, LLC
- Summit Research Solutions, Inc.
- Vanderbilt University
- Amarillo Center for Clinical Research, Ltd.
- Austin Rheumatology Research
- Physicians' Research Options, LLC
- South Puget Sound Clinical Research
- University of Wisconsin, Madison