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Safety and Efficacy of a Monoclonal Antibody for Treatment of Rheumatoid Arthritis.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00034203
Recruitment Status : Completed
First Posted : April 25, 2002
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
XOMA (US) LLC

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: efalizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Study Start Date : April 2002
Study Completion Date : August 2003

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00034203


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Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Rheumatology Associates of North Alabama
Huntsville, Alabama, United States, 35801
United States, Arizona
Arizona Arthritis Research, PLC
Paradise Valley, Arizona, United States, 85253
Advanced Clinical Therapeutics, LLC
Tucson, Arizona, United States, 85715
United States, Arkansas
NEA Clinic
Jonesboro, Arkansas, United States, 72401
Little Rock Diagnostic Clinic
Little Rock, Arkansas, United States, 72205
United States, California
University of California at San Diego
La Jolla, California, United States, 92093-0943
UCLA
Los Angeles, California, United States, 90024
Wallace Rheumatic Study Center
Los Angeles, California, United States, 90048
Boling Clinical Trials
Rancho Cucamonga, California, United States, 91730
Desert Medical Advances
Rancho Mirage, California, United States, 92270
The San Diego Arthritis and Osteoporosis Medical Clinic
San Diego, California, United States, 92120
Pacific Arthritis Center
Santa Maria, California, United States, 93454
United States, Connecticut
Northeast Clinical Research, LLC
Hamden, Connecticut, United States, 06518
Clinical Research Consultants, Inc.
Trumbull, Connecticut, United States, 06611
United States, Florida
Clinical Research of West Florida
Clearwater, Florida, United States, 33765
The Center for Rheumatology, Immunology and Arthritis
Ft. Lauderdale, Florida, United States, 33334
Anchor Research Center
Naples, Florida, United States, 34102
Rheumatology Associates of Central Florida
Orlando, Florida, United States, 32806
nTouch Research Corporation
St. Petersburg, Florida, United States, 33710
Tampa Medical Group
Tampa, Florida, United States, 33614
nTouch Research Corporation
Vero Beach, Florida, United States, 32962
Palm Beach Research Center
West Palm Beach, Florida, United States, 33409
United States, Georgia
nTouch Research Corporation
Decatur, Georgia, United States, 30033
nTouch Research Corporation
Marietta, Georgia, United States, 30066
United States, Indiana
Tri-State Arthritis and Rheumatology Center, LLC
Evansville, Indiana, United States, 47714
United States, Iowa
Central Iowa Hospital Corporation
Des Moines, Iowa, United States, 50309
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Phase III Clinical Research
Fall River, Massachusetts, United States, 02720
United States, Missouri
The Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114
Washington University Center for Clinical Studies
St. Louis, Missouri, United States, 63110
United States, Nevada
Clinical Research Center of Nevada
Las Vegas, Nevada, United States, 89128
United States, New York
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
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, 13326
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Hospital for Joint Disease, ACRC
New York, New York, United States, 10003
Mount Sinai School of Medicine
New York, New York, United States, 10029
Prem C. Chatpar, M.D.
Plainview, New York, United States, 11803
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
United States, Oklahoma
McBride Clinic, Inc.
Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
nTouch Research Corporation
Pittsburgh, Pennsylvania, United States, 15218
Rheumatic Disease Associates
Willow Grove, Pennsylvania, United States, 19090
United States, Tennessee
Volunteer Research Group, LLC
Knoxville, Tennessee, United States, 37920
Summit Research Solutions, Inc.
Memphis, Tennessee, United States, 38119
Vanderbilt University
Nashville, Tennessee, United States, 37232-2681
United States, Texas
Amarillo Center for Clinical Research, Ltd.
Amarillo, Texas, United States, 79106
Austin Rheumatology Research
Austin, Texas, United States, 78705
United States, Utah
Physicians' Research Options, LLC
Ogden, Utah, United States, 84403
United States, Washington
South Puget Sound Clinical Research
Olympia, Washington, United States, 98502
United States, Wisconsin
University of Wisconsin, Madison
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
XOMA (US) LLC

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ClinicalTrials.gov Identifier: NCT00034203     History of Changes
Other Study ID Numbers: HURA501
First Posted: April 25, 2002    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: September 2004

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases