Chernihiv

Researchers are evaluating the safety and effectiveness of Radotinib in patients with chronic phase Philadelphia chromosome-positive chronic myeloid leukemia (CP-CML) who have not responded well or cannot tolerate previous treatments with tyrosine kinase inhibitors (TKIs) including Imatinib. This Phase 3, multinational, multicenter, open-label study aims to enroll 173 participants to better understand Radotinib's impact on this condition. Participants will receive Radotinib capsules at a dose of 400 mg twice daily in a single treatment arm. Radotinib is provided as hard capsules containing 100 mg or 200 mg doses of the drug. Treatment will be administered continuously, and the study includes monitoring for safety and efficacy throughout the course. The study does not include a comparator group but follows participants closely for response to therapy. During the study, participants will be regularly evaluated to monitor their response, including measuring the major cytogenetic response at 6 months. Assessments will include laboratory tests to check organ function and disease status, as well as safety monitoring for side effects. The study requires participants to attend scheduled visits and comply with study procedures, including pregnancy testing for women of childbearing potential and contraception use. The overall participation duration and follow-up details are based on the study protocol.

Researchers are evaluating the safety and effectiveness of SPY072 compared to a placebo in adults aged 18 years and older who have moderately to severely active rheumatic diseases. This Phase 2, multi-center, double-blind, placebo-controlled basket study includes participants with rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), and psoriatic arthritis (PsA) who have not responded adequately to standard treatments. Participants are assigned to receive either SPY072 or a matching placebo. The study includes separate substudies for each condition: RA participants must have active disease despite treatment with conventional or biologic disease-modifying anti-rheumatic drugs; axSpA participants must have active disease despite use of NSAIDs or biologic therapies; PsA participants must have active disease despite NSAIDs, conventional or biologic therapies. Treatments are given during the study period, and participants are monitored for changes in disease activity specific to their condition. During the study, participants undergo assessments including joint counts, disease activity scores, and laboratory tests such as C-reactive protein levels. Researchers measure changes in disease activity scores at 12 or 16 weeks depending on the condition, and evaluate the proportion of PsA participants achieving a clinical response. Safety and efficacy are monitored throughout, with the total participation duration aligned with these outcome measures.

Researchers are evaluating the physical impact of multiple sclerosis (MS) from the participant's perspective while providing continued access to the drug ocrelizumab. This Phase 3 extension study focuses on assessing the safety and tolerability of ocrelizumab, a treatment for MS, at approved doses. The study includes participants who were already receiving ocrelizumab in previous Genentech and/or F. Hoffmann-La Roche Ltd sponsored studies and do not have local access to this treatment through other means. Participants will receive ocrelizumab either by intravenous (IV) infusion at 600 milligrams or by subcutaneous (SC) injection at 920 milligrams, following the dosing schedule from their previous parent study. Treatment will begin no earlier than five months after their last dose in the parent study. This open-label, multicenter extension provides ongoing access to ocrelizumab for up to five years. Throughout the study, participants will be monitored for changes in their physical functioning using the Patient-Reported Outcome Measure Information System/Quality of Life in Neurological Disorders - Physical Function Measure for Multiple Sclerosis (PROMISnq PFMS-15a). Researchers will also track the number of participants receiving ocrelizumab during the study and assess safety and tolerability over the long term. Monitoring includes regular evaluations to ensure participant well-being during the extended treatment period.