A Continuation Trial for Subjects With Rheumatoid Arthritis That Have Completed Protocol LBRA01
- Registration Number
- NCT00583557
- Lead Sponsor
- Human Genome Sciences Inc.
- Brief Summary
This is a continuation trial of LymphoStat-B™ to evaluate the long-term safety in subjects with Rheumatoid Arthritis that completed study LBRA01 and benefitted from treatment.
- Detailed Description
This is a multi-center, open label, continuation trial of LymphoStat-B™ in Rheumatoid Arthritis (RA) subjects who achieved at least an ACR20 response in the Phase 2 study LBRA01 (NCT00071812).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 155
- Have completed the LBRA01 trial.
- Have achieved at least an ACR20 response at the end of LBRA01.
Primary
-
Have switched NSAIDs due to worsening RA disease activity, used more than 10 mg/day of oral prednisone, or were given a corticosteroid injection during the last 30 days of LBRA01.
-
Required a new DMARD (not otherwise excluded in protocol LBRA01) to replace an ineffective one, or an additional DMARD (not to exceed 2 DMARDs in total) within the last 60 days of LBRA01.
-
Used prohibited medications during their participation in LBRA01. These medications include the following:
- Other investigational agents.
- Biologic response modifiers
- Cyclophosphamide.
- Corticosteroid injections (except 1 injection of up to 40 mg of prednisone into an inflamed joint or intramuscularly every 6 months).
- 2 new DMARDs.
- 1 new DMARD plus high dose prednisone >10 mg/day.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Belimumab belimumab -
- Primary Outcome Measures
Name Time Method To Evaluate the Long-term Safety of LymphoStat-B™ in Subjects With RA. Up to 5 years SEE ALSO ADVERSE EVENT (AE) RESULTS SECTION.
- Secondary Outcome Measures
Name Time Method The Efficacy Endpoints Will Include Long-term ACR Responses, DAS28 Response, C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), and Rheumatoid Factor (RF). up to 5 Years NOT ANALYZED
Trial Locations
- Locations (48)
University of Pittsburgh School of Medicine & ASPH
🇺🇸Pittsburgh, Pennsylvania, United States
Wallace Rheumatic Disease Center
🇺🇸Los Angeles, California, United States
IPC Clinical Research
🇺🇸Ogden, Utah, United States
Rheumatic Disease Center
🇺🇸Glendale, Wisconsin, United States
University of Southern CA
🇺🇸Los Angeles, California, United States
Texas Research Center
🇺🇸Sugar Land, Texas, United States
Marshfield Medical Research Foundation
🇺🇸Wausau, Wisconsin, United States
Arthritis Clinic and Carolina Bone and Joint
🇺🇸Charlotte, North Carolina, United States
Seattle Arthritis Clinic
🇺🇸Seattle, Washington, United States
Arthritis Associates & Osteoporosis Center of Colorado Springs
🇺🇸Colorado Springs, Colorado, United States
Univ of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Arizona Arthritis Research
🇺🇸Paradise Valley, Arizona, United States
Arthritis Health
🇺🇸Scottsdale, Arizona, United States
The University of Arizona Health Sciences Center
🇺🇸Tucson, Arizona, United States
Arthritis Care Center, Inc.
🇺🇸San Jose, California, United States
Boling Clinical Trials
🇺🇸Rancho Cucamonga, California, United States
Washington Hospital Center
🇺🇸Washington, DC, District of Columbia, United States
Rheumatology Associates of Central Florida
🇺🇸Orlando, Florida, United States
Arthritis and Rheumatic Disease Specialties
🇺🇸Aventura, Florida, United States
Tampa Medical Group, P.A.
🇺🇸Tampa, Florida, United States
Radiant Research Boise
🇺🇸Boise, Idaho, United States
Rheumatology Associates
🇺🇸Chicago, Illinois, United States
The Osteoporosis and Arthritis Clinical Trial Center
🇺🇸Cumberland, Maryland, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Medical Specialists
🇺🇸Munster, Indiana, United States
Kentuckiana Center for Better Bone and Joint Health
🇺🇸Louisville, Kentucky, United States
Center for Rheumatology and Bone Research
🇺🇸Wheaton, Maryland, United States
Washington University in St. Louis
🇺🇸St. Louis, Missouri, United States
Arthritis Center of Nebraska
🇺🇸Lincoln, Nebraska, United States
Strafford Medical Associates, P.A.
🇺🇸Dover, New Hampshire, United States
The Center for Rheumatology
🇺🇸Albany, New York, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Bone and Joint Hospital - Research Department
🇺🇸Oklahoma City, Oklahoma, United States
Wake Forest Unviersity School of Medicine
🇺🇸Winston-Salem, North Carolina, United States
Oklahoma Medical Reseach Foundation
🇺🇸Oklahoma City, Oklahoma, United States
Oklahoma Center for Arthritis Therapy & Research
🇺🇸Tulsa, Oklahoma, United States
Rheumatic Disease Associates
🇺🇸Willow Grove, Pennsylvania, United States
Arthritis Centers of Texas
🇺🇸Dallas, Texas, United States
UT Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
Houston Institute for Clinical Research
🇺🇸Houston, Texas, United States
Arthritis Clinic of Northern Virginia, P.C.
🇺🇸Arlington, Virginia, United States
Arthritis Northwest Rheumatology
🇺🇸Spokane, Washington, United States
Rheumatology Northwest Clinical Trials
🇺🇸Yakima, Washington, United States
Gundersen Clinic, LTD
🇺🇸La Crosse, Wisconsin, United States
NZOZ Centrum Medyczne
🇵🇱Bialystok, Poland
Wojewodzki Zespol Reumatologiczny
🇵🇱Sopot, Poland
Instytut Reumaologii
🇵🇱Warszawa, Poland
Instytut Reumatologii
🇵🇱Warszawa, Poland