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

The purpose of this study is to determine whether a humanized monoclonal antibody (efalizumab) is safe and effective in the treatment of rheumatoid arthritis.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: efalizumab

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Masking: Double

Collaborators and Investigators

• Sponsor: XOMA (US) LLC

Study record dates

Study Major Dates

• Study Start: April 1, 2002
• Study Completion: August 1, 2003

Study Registration Dates

• First Submitted: April 23, 2002
• First Submitted That Met QC Criteria: April 24, 2002
• First Posted (Estimate): April 25, 2002

Study Record Updates

• Last Update Posted (Estimate): June 24, 2005
• Last Update Submitted That Met QC Criteria: June 23, 2005
• Last Verified: September 1, 2004

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: HURA501