Rheumatoid Arthritis Clinical Trial
Verified date | September 2004 |
Source | XOMA (US) LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to determine whether a humanized monoclonal antibody (efalizumab) is safe and effective in the treatment of rheumatoid arthritis.
Status | Completed |
Enrollment | 0 |
Est. completion date | August 2003 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Amarillo Center for Clinical Research, Ltd. | Amarillo | Texas |
United States | Austin Rheumatology Research | Austin | Texas |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Albert Einstein College of Medicine | Bronx | New York |
United States | State University of New York Health Science Center at Brooklyn | Brooklyn | New York |
United States | Clinical Research of West Florida | Clearwater | Florida |
United States | Bassett Healthcare Clinical Pharmacology Research Center | Cooperstown | New York |
United States | nTouch Research Corporation | Decatur | Georgia |
United States | Central Iowa Hospital Corporation | Des Moines | Iowa |
United States | Altoona Center for Clinical Research | Duncansville | Pennsylvania |
United States | Tri-State Arthritis and Rheumatology Center, LLC | Evansville | Indiana |
United States | Phase III Clinical Research | Fall River | Massachusetts |
United States | The Center for Rheumatology, Immunology and Arthritis | Ft. Lauderdale | Florida |
United States | Northeast Clinical Research, LLC | Hamden | Connecticut |
United States | Rheumatology Associates of North Alabama | Huntsville | Alabama |
United States | NEA Clinic | Jonesboro | Arkansas |
United States | The Center for Pharmaceutical Research | Kansas City | Missouri |
United States | Volunteer Research Group, LLC | Knoxville | Tennessee |
United States | University of California at San Diego | La Jolla | California |
United States | Clinical Research Center of Nevada | Las Vegas | Nevada |
United States | Little Rock Diagnostic Clinic | Little Rock | Arkansas |
United States | UCLA | Los Angeles | California |
United States | Wallace Rheumatic Study Center | Los Angeles | California |
United States | University of Wisconsin, Madison | Madison | Wisconsin |
United States | nTouch Research Corporation | Marietta | Georgia |
United States | Summit Research Solutions, Inc. | Memphis | Tennessee |
United States | Anchor Research Center | Naples | Florida |
United States | Vanderbilt University | Nashville | Tennessee |
United States | Long Island Jewish Medical Center | New Hyde Park | New York |
United States | Hospital for Joint Disease, ACRC | New York | New York |
United States | Mount Sinai School of Medicine | New York | New York |
United States | Physicians' Research Options, LLC | Ogden | Utah |
United States | McBride Clinic, Inc. | Oklahoma City | Oklahoma |
United States | South Puget Sound Clinical Research | Olympia | Washington |
United States | Rheumatology Associates of Central Florida | Orlando | Florida |
United States | Arizona Arthritis Research, PLC | Paradise Valley | Arizona |
United States | nTouch Research Corporation | Pittsburgh | Pennsylvania |
United States | Prem C. Chatpar, M.D. | Plainview | New York |
United States | Boling Clinical Trials | Rancho Cucamonga | California |
United States | Desert Medical Advances | Rancho Mirage | California |
United States | The San Diego Arthritis and Osteoporosis Medical Clinic | San Diego | California |
United States | Pacific Arthritis Center | Santa Maria | California |
United States | Washington University Center for Clinical Studies | St. Louis | Missouri |
United States | nTouch Research Corporation | St. Petersburg | Florida |
United States | State University of New York Upstate Medical University | Syracuse | New York |
United States | Tampa Medical Group | Tampa | Florida |
United States | Clinical Research Consultants, Inc. | Trumbull | Connecticut |
United States | Advanced Clinical Therapeutics, LLC | Tucson | Arizona |
United States | nTouch Research Corporation | Vero Beach | Florida |
United States | Palm Beach Research Center | West Palm Beach | Florida |
United States | Rheumatic Disease Associates | Willow Grove | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
XOMA (US) LLC |
United States,
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