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.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
155
IV 10mg/kg Q28 days
To Evaluate the Long-term Safety of LymphoStat-B™ in Subjects With RA.
SEE ALSO ADVERSE EVENT (AE) RESULTS SECTION.
Time frame: Up to 5 years
The Efficacy Endpoints Will Include Long-term ACR Responses, DAS28 Response, C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), and Rheumatoid Factor (RF).
NOT ANALYZED
Time frame: up to 5 Years
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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
University of Southern CA
Los Angeles, California, United States
Wallace Rheumatic Disease Center
Los Angeles, California, United States
Boling Clinical Trials
Rancho Cucamonga, California, United States
Arthritis Care Center, Inc.
San Jose, California, United States
Arthritis Associates & Osteoporosis Center of Colorado Springs
Colorado Springs, Colorado, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
...and 38 more locations