Safety and Efficacy of a Monoclonal Antibody for Treatment of Rheumatoid Arthritis. | NCT00034203 | Trialant
CompletedInterventionalPhase 2Updated Jun 24, 2005
Safety and Efficacy of a Monoclonal Antibody for Treatment of Rheumatoid Arthritis.
ClinicalTrials.gov ID
NCT00034203
Lead Sponsor
XOMA (US) LLCINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 2
Last Update Posted
Jun 24, 2005Estimated
Start Date
Apr 2002
Completion Date
Aug 2003
Brief Summary
The purpose of this study is to determine whether a humanized monoclonal antibody (efalizumab) is safe and effective in the treatment of rheumatoid arthritis.
Rheumatoid Arthritis
efalizumab
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
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.
Primary Purpose
Treatment
Allocation
Randomized
Masking
Double
No central contacts
There are no central contacts for this study.
University of Alabama at Birmingham
Birmingham, Alabama 35294, United States
Rheumatology Associates of North Alabama
Huntsville, Alabama 35801, United States
Arizona Arthritis Research, PLC
Paradise Valley, Arizona 85253, United States
Advanced Clinical Therapeutics, LLC
Tucson, Arizona 85715, United States
NEA Clinic
Jonesboro, Arkansas 72401, United States
Little Rock Diagnostic Clinic
Little Rock, Arkansas 72205, United States
University of California at San Diego
La Jolla, California 92093-0943, United States
UCLA
Los Angeles, California 90024, United States
Wallace Rheumatic Study Center
Los Angeles, California 90048, United States
Boling Clinical Trials
Rancho Cucamonga, California 91730, United States
Desert Medical Advances
Rancho Mirage, California 92270, United States
The San Diego Arthritis and Osteoporosis Medical Clinic
San Diego, California 92120, United States
Pacific Arthritis Center
Santa Maria, California 93454, United States
Northeast Clinical Research, LLC
Hamden, Connecticut 06518, United States
Clinical Research Consultants, Inc.
Trumbull, Connecticut 06611, United States
Clinical Research of West Florida
Clearwater, Florida 33765, United States
The Center for Rheumatology, Immunology and Arthritis
Fort Lauderdale, Florida 33334, United States
Anchor Research Center
Naples, Florida 34102, United States
Rheumatology Associates of Central Florida
Orlando, Florida 32806, United States
nTouch Research Corporation
St. Petersburg, Florida 33710, United States
Tampa Medical Group
Tampa, Florida 33614, United States
nTouch Research Corporation
Vero Beach, Florida 32962, United States
Palm Beach Research Center
West Palm Beach, Florida 33409, United States
nTouch Research Corporation
Decatur, Georgia 30033, United States
nTouch Research Corporation
Marietta, Georgia 30066, United States
Tri-State Arthritis and Rheumatology Center, LLC
Evansville, Indiana 47714, United States
Central Iowa Hospital Corporation
Des Moines, Iowa 50309, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215, United States
Phase III Clinical Research
Fall River, Massachusetts 02720, United States
The Center for Pharmaceutical Research
Kansas City, Missouri 64114, United States
Washington University Center for Clinical Studies
St Louis, Missouri 63110, United States
Clinical Research Center of Nevada
Las Vegas, Nevada 89128, United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, United States
Bassett Healthcare Clinical Pharmacology Research Center
Cooperstown, New York 13326, United States
Long Island Jewish Medical Center
New Hyde Park, New York 11040, United States
Hospital for Joint Disease, ACRC
New York, New York 10003, United States
Mount Sinai School of Medicine
New York, New York 10029, United States
Prem C. Chatpar, M.D.
Plainview, New York 11803, United States
State University of New York Upstate Medical University