Rheumatoid arthritis (RA) affects 1 percent of the population worldwide and up to 40 percent of patients don't respond to current treatments. MBS2320, the drug being tested in this trial, represents a new approach to treating RA, with the potential not only to reduce levels of inflammation but to also directly prevent bone damage.The aim of this project is to test the safety, tolerability and efficacy of MBS2320 in patients with RA in combination with an existing treatment, methotrexate.
Rheumatoid Arthritis is a chronic autoimmune disease characterised by synovial inflammation and cartilage and bone degradation, leading to joint destruction and progressive disability. The aim of the study is to evaluate the safety and tolerability of MBS2320 in patients with RA following chronic administration. In addition, the study aims to evaluate the effects of MBS2320 on measures of disease activity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
121
Arensia
Tbilisi, Georgia
Arensia
Chisinau, Moldova
Arensia
Bucharest, Romania
Incidence of treatment-emergent adverse events (safety and tolerability)
Incidence of all grade adverse events
Time frame: 12 weeks
Disease Activity Score 28 (DAS28)
Disease Activity Score according to the EULAR response criteria
Time frame: 12 weeks
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