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Sponsored by: |
Human Genome Sciences |
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Information provided by: | Human Genome Sciences |
ClinicalTrials.gov Identifier: | NCT00071812 |
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 | Intervention | Phase |
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Arthritis, Rheumatoid |
Drug: belimumab (LymphoStat-B) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA) |
Enrollment: | 296 |
Study Start Date: | December 2003 |
Study Completion Date: | December 2005 |
The purpose of this study is to evaluate the safety and efficacy of three different doses of LymphoStat-B, administered in addition to standard therapy, in subjects with RA.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Primary Inclusion Criteria:
Primary Exclusion Criteria:
Study Director: | William Freimuth, MD, PhD | Human Genome Sciences, Inc. |
Responsible Party: | Human Genome Sciences, Inc. ( William Freimuth, MD, PhD, Vice President of Clinical Research, Immunology, Rheumatology and Infectious Diseases ) |
Study ID Numbers: | LBRA01 |
Study First Received: | October 31, 2003 |
Last Updated: | April 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00071812 History of Changes |
Health Authority: | United States: Food and Drug Administration; Poland: Ministry of Health |
RA |
Antibodies Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases Immunoglobulins |
Autoimmune Diseases Immune System Diseases Musculoskeletal Diseases Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |