The first stage of clinical trials (CI) for an R-Pharm Group drug based on olokizumab (Artlegia) has begun at Sechenov University's N. F. Filatov Clinical Institute of Children's Health. The medication is intended to treat juvenile idiopathic arthritis in adolescents.
The disease can cause disability if not treated promptly. "Olokizumab is the world's first monoclonal antibody registered for the treatment of rheumatoid arthritis, which directly blocks interleukin-6, a molecule involved in inflammatory, including rheumatic, processes," the State Corporation's press service stated.
The novel biological drug is manufactured at the R-Pharm Yaroslavl plant, ensuring continuous supply of rheumatoid arthritis patients throughout the country.
Adolescents (15 people) in the study will be given the drug according to the regimen approved for the treatment of rheumatoid arthritis in adults. The study will not use active or placebo controls, and all patients will receive the same treatment. If clinical studies show that the drug is safe and effective in juvenile arthritis, it will be tested in children and adolescents with systemic arthritis.
"R-Pharm has started a clinical trial to provide effective and modern biological therapy to Russian paediatric and adolescent patients," said Mikhail Samsonov, R-Pharm's medical director.
According to the institute's director, Ekaterina Alekseeva, the upcoming multiyear multicenter study will be "perhaps the first study of this level in Russia in the child population." She went on to say that Sechenov University could become a leader in this field in Russia.