The clinical trial is aimed to demonstrate non-inferiority of the investigational drug as compared to the reference product, as well as to compare their safety profiles.
A total of more than 280 patients with active rheumatoid arthritis will be enrolled into the study. For this purpose, 380 men and women aged 18-70 years are expected to be screened. Patients will be equally randomized into treatment groups. The expected total duration of involvement of each subject into this clinical trial will be about slightly more than one year. The study consists of screening, treatment and follow-up periods. The efficacy, safety, pharmacokinetics and immunogenicity of the compared drugs will be estimated in patients throughout the whole period of the study.
Upon completion of the first half of the study, an interim analysis will be performed to determine the presence or absence of therapeutic equivalence between the compared treatments. A final report will be prepared after the end of the study. The clinical data will be used to support an application for marketing authorization of the investigational medicinal product.
In this project OCT is responsible for communication with all investigational sites, coordination of work of a central lab, logistics and data management. Our team successfully completed over 60 III phase trials and has profound understanding of specifics of such projects.