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Sponsored by: |
Human Genome Sciences |
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Information provided by: | Human Genome Sciences |
ClinicalTrials.gov Identifier: | NCT00583557 |
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.
Condition | Intervention | Phase |
---|---|---|
Rheumatoid Arthritis |
Drug: belimumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Open-Label, Continuation Trial of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA) Who Completed the Phase 2 Protocol LBRA01 |
Enrollment: | 155 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: belimumab
IV 10mg/kg Q28 days
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Primary Inclusion Criteria:
Primary Exclusion Criteria:
Used prohibited medications during their participation in LBRA01. These medications include the following:
Study Director: | William Freimuth, MD, PhD | Human Genome Sciences, Inc. |
Responsible Party: | Human Genome Sciences ( William Freimuth, MD, PhD/Vice President, Clinical Research Immunology, Rheumatology & Infectious Diseases ) |
Study ID Numbers: | LBRA99 |
Study First Received: | December 20, 2007 |
Last Updated: | April 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00583557 |
Health Authority: | United States: Food and Drug Administration; Poland: Ministry of Health |
Rheumatoid Arthritis RA |
Antibodies Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases Immunoglobulins |
Immune System Diseases |