The purpose of this study is to evaluate the safety and efficacy of 3 different doses of LymphoStat-B, administered in addition to standard therapy, in subjects with RA.

Condition	Treatment or Intervention	Phase
Arthritis, Rheumatoid	Drug: belimumab (LymphoStat-B)	Phase II

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Primary Inclusion Criteria:

• Diagnosis of RA for at least 1 year
• Failed at least 1 disease modifying anti-rheumatic drug (DMARD) due to toxicity or lack of efficacy. These drugs must include 1 or more of the following: methotrexate, parenteral gold, sulfasalazine, leflunomide, and TNFα inhibitors (infliximab, etanercept or adalimumab)
• Active RA disease of at least moderate disease activity
• Be on a stable RA treatment regimen for at least the past 60 days (for DMARDS); if on non-steroidal anti-inflammatory drugs (NSAIDs) or steriods these must be at a stable dose for the last 30 days

Primary Exclusion Criteria:

• Received a non-FDA approved investigational agent within the last 28 days
• Currently receiving or received within the last 60 days the following: TNFα-inhibitors (infliximab, etanercept, adalimumab) or interleukin-1 receptor antagonist (anakinra)
• Currently receiving or received within the last 6 months the following: anti-CD20 antibody(rituximab)or cyclophosphamide
• Steroid injection into any joint within the last 30 days
• History of hypogammaglobulinemia or IgA deficiency
• History of chronic infection that has been active within last 6 months, or herpes zoster within last 90 days, or any infection requiring hospitalization or intravenous medication within last 60 days
• HIV, Hepatitis-B, Heptatitis-C

Alabama
      University of Alabama at Birmingham, Birmingham,  Alabama,  35294-0006,  United States
Arizona
      Arizona Arthritis Research, Paradise Valley,  Arizona,  85253,  United States
      University of Arizona, Tucson,  Arizona,  85724,  United States
California
      Arthritis Care Center, Inc., San Jose,  California,  95126-1650,  United States
      Boling Clinical Trials, Rancho Cucamonga,  California,  91730,  United States
      Cedars-Sinai Medical Center, Los Angeles,  California,  90048,  United States
      Scripps Clinic, LaJolla,  California,  92037,  United States
      Stanford University School of Medicine, Palo Alto,  California,  94304,  United States
      UCDMC, Sacramento,  California,  95817-1418,  United States
      University of Southern California, Los Angeles,  California,  90033,  United States
      Wallace Rheumatic Disease Center, Los Angeles,  California,  90048,  United States
Colorado
      Arthritis Associates & Osteoporosis Center Of Colorado Springs, Colorado Springs,  Colorado,  80910,  United States
District of Columbia
      Washington Hospital Center, Washington,  District of Columbia,  20010,  United States
Florida
      Arthritis and Rheumatic Disease Specialties, Aventura,  Florida,  33180,  United States
      Tampa Medical Group, P.A., Tampa,  Florida,  33614,  United States
      Rheumatology Associates of Central Florida, Orlando,  Florida,  32806,  United States
Idaho
      Radiant Research Boise, Boise,  Idaho,  83704,  United States
      Institute of Arthritis and Research, Idaho Falls,  Idaho,  83404,  United States
Illinois
      Northwestern University Medical School, Chicago,  Illinois,  60611,  United States
      Rockford Clinic, Rockford,  Illinois,  61103,  United States
      Rheumatology Associates, Chicago,  Illinois,  60612,  United States
Indiana
      Medical Specialists, Munster,  Indiana,  46321,  United States
Kentucky
      Kentuckiana Center for Better Bone and Joint Health, Louisville,  Kentucky,  40202,  United States
Louisiana
      Ochsner Clinic Foundation, Baton Rouge,  Louisiana,  70809,  United States
Maryland
      Center for Rhematology and Bone Research, Wheaton,  Maryland,  20902,  United States
      Johns Hopkins Hospital, Baltimore,  Maryland,  21287,  United States
      The Osteoporosis and Arthritis Clinical Trial Center, Cumberland,  Maryland,  21502,  United States
Massachusetts
      Tufts - New England Medical Center, Boston,  Massachusetts,  02111,  United States
Michigan
      The University of Michigan Health System, Ann Arbor,  Michigan,  48109-0358,  United States
Minnesota
      Mayo Clinic, Rochester,  Minnesota,  55905,  United States
Missouri
      Washington University in St. Louis, St. Louis,  Missouri,  63110,  United States
Nebraska
      Arthritis Center of Nebraska, Lincoln,  Nebraska,  68506,  United States
New Hampshire
      Arthritis and Osteoporosis Center, Concord,  New Hampshire,  03301,  United States
      Strafford Medical Associates, P.A., Dover,  New Hampshire,  03820,  United States
New York
      Jacobi Medical Center, Bronx,  New York,  10461,  United States
      North Shore University Hospital, Manhasset,  New York,  11030,  United States
      SUNY-Downstate Medical Center, Brooklyn,  New York,  11203,  United States
      The Center For Rheumatology, Albany,  New York,  12206,  United States
North Carolina
      Arthritis Clinic and Carolina Bone and Joint, Charlotte,  North Carolina,  28210,  United States
      University of North Carolina at Chapel Hill, Chapel Hill,  North Carolina,  27599-7280,  United States
      Wake Forest University School of Medicine, Winston Salem,  North Carolina,  27157,  United States
Ohio
      Stat Research, Inc., Dayton,  Ohio,  45402,  United States
Oklahoma
      Oklahoma Center For Arthritis Therapy & Research, Tulsa,  Oklahoma,  74114,  United States
      Oklahoma Medical Research Foundation, Oklahoma City,  Oklahoma,  73104,  United States
      McBride Clinic, Oklahoma City,  Oklahoma,  73101,  United States
Pennsylvania
      Rheumatic Disease Associates, Willow Grove,  Pennsylvania,  19090,  United States
      Thomas Jefferson University Hospital, Philadelphia,  Pennsylvania,  19107,  United States
      University of Pittsburgh School of Medicine & ASPH, Pittsburgh,  Pennsylvania,  15261,  United States
Texas
      Research Associates of North Texas, Dallas,  Texas,  75246,  United States
      UT Southwestern Medical Center at Dallas, Dallas,  Texas,  75390-8884,  United States
      Arthritis Centers of Texas, Dallas,  Texas,  75246,  United States
      Texas Research Center, Sugar Land,  Texas,  77479,  United States
      Houston Institute for Clinical Research, Houston,  Texas,  77074,  United States
Utah
      Arthritis and Rheumatic Diseases Clinic, Weber,  Utah,  84403,  United States
Virginia
      Arthritis Clinic of Northern Virginia, P.C., Arlington,  Virginia,  22205,  United States
Washington
      Edmonds Rheumatology Associates, Edmonds,  Washington,  98026-8047,  United States
      Arthritis Northwest Rheumatology, Spokane,  Washington,  99204,  United States
      Evergreen Clinical Reserach, Edmonds,  Washington,  98026-8047,  United States
      Rheumatology Northwest Clinical Trials, Yakima,  Washington,  98902,  United States
Wisconsin
      Gundersen Clinic, Ltd., La Crosse,  Wisconsin,  54610,  United States
      The Medical College of Wisconsin , Inc, Milwaukee,  Wisconsin,  53226,  United States
      Marshfield Medical Research Foundation, Wausau,  Wisconsin,  54401,  United States
      Rheumatic Disease Center, Glendale,  Wisconsin,  53217,  United States

Study ID Numbers:  LBRA01
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  October 31, 2003
ClinicalTrials.gov Identifier:  NCT00071812
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08