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Home > "S" Clinical Trials Conditions > Safety and efficacy of a monoclonal antibody for treatment of rheumatoid arthritis.  Safety and efficacy of a monoclonal antibody for treatment of rheumatoid arthritis.
Safety and efficacy of a monoclonal antibody for treatment of rheumatoid arthritis.
For Condition: Rheumatoid Arthritis
Status: No longer recruiting
Sponsor(s): XOMA ,
Synopsis: The purpose of this study is to determine whether a humanized monoclonal antibody (efalizumab) is safe and effective in the treatment of rheumatoid arthritis.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/80 Years
Genders: Both
Protocol Entry 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.
Total Enrollment:
Location and Contact Information:
Rheumatic Disease Associates
Willow Grove, Pennsylvania, 19090
United States
The San Diego Arthritis and Osteoporosis Medical Clinic
San Diego, California, 92120
United States
Summit Research Solutions, Inc.
Memphis, Tennessee, 38119
United States
Austin Rheumatology Research
Austin, Texas, 78705
United States
State University of New York Upstate Medical University
Syracuse, New York, 13210
United States
nTouch Research Corporation
Vero Beach, Florida, 32962
United States
Volunteer Research Group, LLC
Knoxville, Tennessee, 37920
United States
Clinical Research of West Florida
Clearwater, Florida, 33765
United States
Amarillo Center for Clinical Research, Ltd.
Amarillo, Texas, 79106
United States
Prem C. Chatpar, M.D.
Plainview, New York, 11803
United States
Central Iowa Hospital Corporation
Des Moines, Iowa, 50309
United States
Washington University Center for Clinical Studies
St. Louis, Missouri, 63110
United States
UCLA
Los Angeles, California, 90024
United States
Bassett Healthcare Clinical Pharmacology Research Center
Cooperstown, New York, 13326
United States
Vanderbilt University
Nashville, Tennessee, 37232-2681
United States
nTouch Research Corporation
St. Petersburg, Florida, 33710
United States
Boling Clinical Trials
Rancho Cucamonga, California, 91730
United States
NEA Clinic
Jonesboro, Arkansas, 72401
United States
Rheumatic Disease Associates
Willow Grove, Pennsylvania, 19090
United States
The Center for Pharmaceutical Research
Kansas City, Missouri, 64114
United States
Tampa Medical Group
Tampa, Florida, 33614
United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York,
United States
Tri-State Arthritis and Rheumatology Center, LLC
Evansville, Indiana, 47714
United States
Advanced Clinical Therapeutics, LLC
Tucson, Arizona, 85715
United States
Wallace Rheumatic Study Center
Los Angeles, California, 90048
United States
Desert Medical Advances
Rancho Mirage, California, 92270
United States
Albert Einstein College of Medicine
Bronx, New York, 10461
United States
nTouch Research Corporation
Pittsburgh, Pennsylvania, 15218
United States
nTouch Research Corporation
Decatur, Georgia, 30033
United States
Clinical Research Center of Nevada
Las Vegas, Nevada, 89128
United States
Clinical Research Consultants, Inc.
Trumbull, Connecticut, 06611
United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
The Center for Rheumatology, Immunology and Arthritis
Ft. Lauderdale, Florida, 33334
United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
United States
Little Rock Diagnostic Clinic
Little Rock, Arkansas, 72205
United States
Palm Beach Research Center
West Palm Beach, Florida, 33409
United States
Rheumatology Associates of Central Florida
Orlando, Florida, 32806
United States
Pacific Arthritis Center
Santa Maria, California, 93454
United States
Mount Sinai School of Medicine
New York City, New York, 10029
United States
South Puget Sound Clinical Research
Olympia, Washington, 98502
United States
Arizona Arthritis Research, PLC
Paradise Valley, Arizona, 85253
United States
University of Wisconsin, Madison
Madison, Wisconsin, 53792
United States
Physicians' Research Options, LLC
Ogden, Utah, 84403
United States
Phase III Clinical Research
Fall River, Massachusetts, 02720
United States
McBride Clinic, Inc.
Oklahoma City, Oklahoma, 73103
United States
Rheumatology Associates of North Alabama
Huntsville, Alabama, 35801
United States
University of California at San Diego
La Jolla, California, 92093-0943
United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
United States
nTouch Research Corporation
Marietta, Georgia, 30066
United States
Anchor Research Center
Naples, Florida, 34102
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Northeast Clinical Research, LLC
Hamden, Connecticut, 06518
United States
Hospital for Joint Disease, ACRC
New York City, New York, 10003
United States
Additional Information:
Study ID Numbers: HURA501;
Study Start Date: April 2002
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00034203
Other Rheumatoid Arthritis Studies:
1. Treating Rheumatoid Arthritis with Tripterygium Wilfordi Hook F or Sulfasalazine
2. Specimen Collection for Individuals with Lung Disease Associated with Rheumatoid Arthritis
3. Phase I Study of High-Dose Cyclophosphamide, Anti-Thymocyte Globulin, and Total Body Irradiation With T-Cell-Depleted Autologous Bone Marrow Rescue in Patients With High-Risk Rheumatoid Arthritis
4. Efficacy & Safety of an Investigational Drug + Methotrexate Compared to Methotrexate Alone in Patients with Rheumatoid Arthritis
5. Genetic Registry for Rheumatoid Arthritis
Related Studies:
Other Rheumatoid Arthritis Clinical Trials
Other Florida Clinical Trials
Other Orlando Clinical Trials
Safety and efficacy of a monoclonal antibody for treatment of rheumatoid arthritis.
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