Rheumatoid Arthritis Clinical Trial
Official title:
A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Preliminary Clinical Activity and Immunogenicity of Multiple Doses of MOR103 Administered Intravenously to Patients With Active Rheumatoid Arthritis
GM-CSF is considered to have a key role in the initiation and progression of arthritic inflammation. The purpose of this study is to evaluate the safety, preliminary efficacy, pharmacokinetics, and immunogenicity of multiple doses of MOR103, a human antibody to GM-CSF, in patients with active rheumatoid arthritis.
Rheumatoid arthritis (RA) is a chronic systemic inflammatory disease that affects 0.5% to 1%
of the adult population world wide. RA primarily affects the joints and is characterized by
chronic inflammation of the synovial tissue, which eventually leads to the destruction of
cartilage, bone and ligaments and can cause joint deformity.
Pro-inflammatory cytokines, such as tumor necrosis factor-alpha (TNFα), interleukin (IL)-1,
IL-6 and granulocyte macrophage colony stimulating factor (GM-CSF), which lead to the
activation and proliferation of immune cells, are found to be increased in the inflamed
joint. Several preclinical findings support an anti-GM-CSF therapy for RA.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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