OCT is preparing for a phase IIb/III clinical trial in patients with rheumatoid and psoriatic arthritis. This will be a multi-center clinical study of efficacy, safety and pharmacodynamics of the investigational product. There will be about 150 patients with the both indication entered in the study.
Psoriatic arthritis affects 5-7% of patients diagnosed with psoriasis. 70% of patients suffer from the joint syndrome after skin reactions of psoriasis, in 15-20% of patients the syndrome develops before skin reactions, and 10% of patients have the both symptoms at the same time.
Rheumatoid arthritis is a chronic autoimmune systemic inflammatory disease of conjunctive tissue, which usually affects joints in the way of erosion-destructive progressing polyarthritis. About 1% of population suffer from this disease. In the world, there are almost 60 mln. RA cases.
In order to recruit patients for this clinical study, OCT plan to have more than 15 sites. OCT have well-developed connections with the specialized clinics not only in St. Petersburg and Moscow, but also in remote cities in Russia, and OCT are going to initiate sites in several cities in Russia. The results of therapy, and efficacy of the drugs will be evaluated according to American College of Rheumatology scale, Disease Activity Score scale, and some other parameters.