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Study of LymphoStat-B (monoclonal anti-BLyS antibody) in Subjects with Rheumatoid Arthritis (RA)



Study of LymphoStat-B (monoclonal anti-BLyS antibody) in Subjects with Rheumatoid Arthritis (RA)

For Condition: Arthritis, Rheumatoid
Status: Recruiting
Sponsor(s): Human Genome Sciences ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Rheumatic Disease Associates *Recruiting*
Willow Grove,  Pennsylvania,  19090
United States
Recruiting  

Tampa Medical Group, P.A. *Recruiting*
Tampa,  Florida,  33614
United States
Recruiting  

Arthritis and Rheumatic Disease Specialties *Not yet recruiting*
Aventura,  Florida,  33180
United States
Not yet recruiting  

Stanford University School of Medicine *Recruiting*
Palo Alto,  California,  94304
United States
Recruiting  

The University of Michigan Health System *Not yet recruiting*
Ann Arbor,  Michigan,  48109-0358
United States
Not yet recruiting  

Scripps Clinic *Not yet recruiting*
LaJolla,  California,  92037
United States
Not yet recruiting  

SUNY-Downstate Medical Center *Not yet recruiting*
Brooklyn,  New York,  11203
United States
Not yet recruiting  

Thomas Jefferson University Hospital *Not yet recruiting*
Philadelphia,  Pennsylvania,  19107
United States
Not yet recruiting  

UT Southwestern Medical Center at Dallas *Not yet recruiting*
Dallas,  Texas,  75390-8884
United States
Not yet recruiting  

UCDMC *Not yet recruiting*
Sacramento,  California,  95817-1418
United States
Not yet recruiting  

Arthritis and Rheumatic Diseases Clinic *Not yet recruiting*
Weber,  Utah,  84403
United States
Not yet recruiting  

Boling Clinical Trials *Recruiting*
Rancho Cucamonga,  California,  91730
United States
Recruiting  

Arthritis Center of Nebraska *Recruiting*
Lincoln,  Nebraska,  68506
United States
Recruiting  

Rockford Clinic *Not yet recruiting*
Rockford,  Illinois,  61103
United States
Not yet recruiting  

Research Associates of North Texas *Not yet recruiting*
Dallas,  Texas,  75246
United States
Not yet recruiting  

Arthritis Care Center, Inc. *Recruiting*
San Jose,  California,  95126-1650
United States
Recruiting  

Ochsner Clinic Foundation *Recruiting*
Baton Rouge,  Louisiana,  70809
United States
Recruiting  

Arthritis Associates & Osteoporosis Center Of Colorado Springs *Not yet recruiting*
Colorado Springs,  Colorado,  80910
United States
Not yet recruiting  

Evergreen Clinical Reserach *Recruiting*
Edmonds,  Washington,  98026-8047
United States
Recruiting  

Washington University in St. Louis *Not yet recruiting*
St. Louis,  Missouri,  63110
United States
Not yet recruiting  

University of Southern California *Not yet recruiting*
Los Angeles,  California,  90033
United States
Not yet recruiting  

University of Pittsburgh School of Medicine & ASPH *Not yet recruiting*
Pittsburgh,  Pennsylvania,  15261
United States
Not yet recruiting  

Gundersen Clinic, Ltd. *Not yet recruiting*
La Crosse,  Wisconsin,  54610
United States
Not yet recruiting  

The Osteoporosis and Arthritis Clinical Trial Center *Recruiting*
Cumberland,  Maryland,  21502
United States
Recruiting  

Northwestern University Medical School *Not yet recruiting*
Chicago,  Illinois,  60611
United States
Not yet recruiting  

Arthritis and Osteoporosis Center *Not yet recruiting*
Concord,  New Hampshire,  03301
United States
Not yet recruiting  

Rheumatic Disease Center *Not yet recruiting*
Glendale,  Wisconsin,  53217
United States
Not yet recruiting  

The Medical College of Wisconsin , Inc *Not yet recruiting*
Milwaukee,  Wisconsin,  53226
United States
Not yet recruiting  

Arthritis Northwest Rheumatology *Recruiting*
Spokane,  Washington,  99204
United States
Recruiting  

Arthritis Clinic and Carolina Bone and Joint *Recruiting*
Charlotte,  North Carolina,  28210
United States
Recruiting  

Arthritis Clinic of Northern Virginia, P.C. *Not yet recruiting*
Arlington,  Virginia,  22205
United States
Not yet recruiting  

Arizona Arthritis Research *Not yet recruiting*
Paradise Valley,  Arizona,  85253
United States
Not yet recruiting  

University of North Carolina at Chapel Hill *Not yet recruiting*
Chapel Hill,  North Carolina,  27599-7280
United States
Not yet recruiting  

Kentuckiana Center for Better Bone and Joint Health *Not yet recruiting*
Louisville,  Kentucky,  40202
United States
Not yet recruiting  

Johns Hopkins Hospital *Not yet recruiting*
Baltimore,  Maryland,  21287
United States
Not yet recruiting  

Mayo Clinic *Not yet recruiting*
Rochester,  Minnesota,  55905
United States
Not yet recruiting  

Edmonds Rheumatology Associates *Not yet recruiting*
Edmonds,  Washington,  98026-8047
United States
Not yet recruiting  

Oklahoma Center For Arthritis Therapy & Research *Not yet recruiting*
Tulsa,  Oklahoma,  74114
United States
Not yet recruiting  

University of Arizona *Not yet recruiting*
Tucson,  Arizona,  85724
United States
Not yet recruiting  

Washington Hospital Center *Not yet recruiting*
Washington D.C.,  District of Columbia,  20010
United States
Not yet recruiting  

Strafford Medical Associates, P.A. *Recruiting*
Dover,  New Hampshire,  03820
United States
Recruiting  

North Shore University Hospital *Not yet recruiting*
Manhasset,  New York,  11030
United States
Not yet recruiting  

Oklahoma Medical Research Foundation *Not yet recruiting*
Oklahoma City,  Oklahoma,  73104
United States
Not yet recruiting  

Medical Specialists *Recruiting*
Munster,  Indiana,  46321
United States
Recruiting  

Marshfield Medical Research Foundation *Not yet recruiting*
Wausau,  Wisconsin,  54401
United States
Not yet recruiting  

Cedars-Sinai Medical Center *Not yet recruiting*
Los Angeles,  California,  90048
United States
Not yet recruiting  

Arthritis Centers of Texas *Recruiting*
Dallas,  Texas,  75246
United States
Recruiting  

Center for Rhematology and Bone Research *Recruiting*
Wheaton,  Maryland,  20902
United States
Recruiting  

McBride Clinic *Recruiting*
Oklahoma City,  Oklahoma,  73101
United States
Recruiting  

Radiant Research Boise *Recruiting*
Boise,  Idaho,  83704
United States
Recruiting  

University of Alabama at Birmingham *Not yet recruiting*
Birmingham,  Alabama,  35294-0006
United States
Not yet recruiting  

Jacobi Medical Center *Not yet recruiting*
Bronx,  New York,  10461
United States
Not yet recruiting  

Wake Forest University School of Medicine *Not yet recruiting*
Winston Salem,  North Carolina,  27157
United States
Not yet recruiting  


Additional Information:
Study ID Numbers:
  LBRA01; 
Study Start Date: 
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00071812

Other Arthritis, Rheumatoid Studies:
1. Methotrexate Alone Versus Combination of Methotrexate and Subcutaneous Fludarabine for Severe Rheumatoid Arthritis: Safety, Tolerance and Efficacy

2. Study of LymphoStat-B (monoclonal anti-BLyS antibody) in Subjects with Rheumatoid Arthritis (RA)

3. Safety Study of SCIO-469 to treat Patients with Active Rheumatoid Arthritis Receiving Methotrexate

4. The Pathogenesis of Inflammatory Synovitis: A Study of Early Arthritis

5. A Rheumatoid Arthritis (RA) Study Treating Signs and Symptoms of RA in People With RA & Receiving Methotrexate

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