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	Treatment or Intervention	Phase
Rheumatoid Arthritis	Drug: efalizumab	Phase II

Further Study Details: 

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

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.

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

Study ID Numbers:  HURA501
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  April 23, 2002
ClinicalTrials.gov Identifier:  NCT00034203
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08