Russia’s Ministry of Health has approved an international, multicentre, double-blind, randomised, placebo-controlled clinical trial of goflicicept and the second-line therapy drug olokizumab in patients with Still’s disease, according to the state register. The trial is planned to be conducted at 25 clinical centres, including Sechenov First Moscow State Medical University and Pirogov Russian National Research Medical University. It will involve 85 patients and is scheduled to be completed by the end of 2028.
As Elena Tarkhova, head of the clinical research group in immunology at R-Pharm, told GxP News, systemic juvenile idiopathic arthritis (sJIA) and adult-onset Still’s disease (AOSD) are now considered the same disease, characterised by systemic inflammation. However, she said, there is no unified approach to diagnosis and treatment.
Citing current guidelines, Tarkhova noted that IL‑1 and IL‑6 inhibitors, which include R-Pharm’s goflicicept and olokizumab, are used as first-line therapy. This makes it possible to achieve treatment goals – drug-free remission and the elimination of glucocorticosteroid use.
“We believe that the design of our study will enable us to achieve drug-free remission and reduce the risk of life-threatening complications of Still’s disease,” the expert noted.
Still’s disease is a rare autoinflammatory disorder (a form of systemic juvenile arthritis or adult-onset disease) characterised by systemic inflammation and arthritis that begin before the age of 16. Systemic features include fever, rash, hepatomegaly, splenomegaly, lymphadenopathy and serositis. The exact causes of the disease are unknown; they are often linked to triggers (such as viruses) in genetically predisposed individuals.
Olokizumab (brand name Artlegia) is already registered in Russia for the following indications: moderate‑to‑severe active rheumatoid arthritis in adults (in combination with methotrexate), and cytokine release syndrome in moderate-to-severe COVID‑19. In addition to Russia, it is also approved in several other countries, including Kazakhstan, Belarus, Kyrgyzstan and Azerbaijan. The drug is included in the clinical guidelines for rheumatoid arthritis and the Russian List of Vital and Essential Drugs (ZhNVLP).
