Safety and Efficacy of a Monoclonal Antibody for Treatment of Rheumatoid Arthritis.
NCT ID: NCT00034203
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
2002-04-30
2003-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
TREATMENT
DOUBLE
Interventions
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efalizumab
Eligibility Criteria
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Inclusion Criteria
* On stable dose of methotrexate.
* 18 to 80 years of age.
* Less than 275 lbs.
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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XOMA (US) LLC
INDUSTRY
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Rheumatology Associates of North Alabama
Huntsville, Alabama, United States
Arizona Arthritis Research, PLC
Paradise Valley, Arizona, United States
Advanced Clinical Therapeutics, LLC
Tucson, Arizona, United States
NEA Clinic
Jonesboro, Arkansas, United States
Little Rock Diagnostic Clinic
Little Rock, Arkansas, United States
University of California at San Diego
La Jolla, California, United States
UCLA
Los Angeles, California, United States
Wallace Rheumatic Study Center
Los Angeles, California, 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
Northeast Clinical Research, LLC
Hamden, Connecticut, United States
Clinical Research Consultants, Inc.
Trumbull, Connecticut, United States
Clinical Research of West Florida
Clearwater, Florida, United States
The Center for Rheumatology, Immunology and Arthritis
Fort Lauderdale, Florida, United States
Anchor Research Center
Naples, Florida, United States
Rheumatology Associates of Central Florida
Orlando, Florida, United States
nTouch Research Corporation
St. Petersburg, Florida, United States
Tampa Medical Group
Tampa, Florida, United States
nTouch Research Corporation
Vero Beach, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
nTouch Research Corporation
Decatur, Georgia, United States
nTouch Research Corporation
Marietta, Georgia, United States
Tri-State Arthritis and Rheumatology Center, LLC
Evansville, Indiana, United States
Central Iowa Hospital Corporation
Des Moines, Iowa, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Phase III Clinical Research
Fall River, Massachusetts, United States
The Center for Pharmaceutical Research
Kansas City, Missouri, United States
Washington University Center for Clinical Studies
St Louis, Missouri, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, 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, 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
Prem C. Chatpar, M.D.
Plainview, New York, United States
State University of New York Upstate Medical University
Syracuse, New York, United States
Albert Einstein College of Medicine
The Bronx, New York, United States
McBride Clinic, Inc.
Oklahoma City, Oklahoma, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
nTouch Research Corporation
Pittsburgh, Pennsylvania, United States
Rheumatic Disease Associates
Willow Grove, Pennsylvania, United States
Volunteer Research Group, LLC
Knoxville, Tennessee, United States
Summit Research Solutions, Inc.
Memphis, Tennessee, United States
Vanderbilt University
Nashville, Tennessee, United States
Amarillo Center for Clinical Research, Ltd.
Amarillo, Texas, United States
Austin Rheumatology Research
Austin, Texas, United States
Physicians' Research Options, LLC
Ogden, Utah, United States
South Puget Sound Clinical Research
Olympia, Washington, United States
University of Wisconsin, Madison
Madison, Wisconsin, United States
Countries
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Other Identifiers
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HURA501
Identifier Type: -
Identifier Source: org_study_id