Study of Olokizumab Treatment for Children and Teens With Juvenile Idiopathic Arthritis Evaluating Safety, Effectiveness, and How the Drug Works in the Body

What this Trial Is About

Researchers are studying the pharmacokinetics, safety, and long-term effectiveness of olokizumab in children and adolescents aged over 2 and under 18 years who have polyarticular juvenile idiopathic arthritis. This open-label, multicenter study aims to understand how the drug behaves in the body, its effects, and its safety over an extended period. Participants receive subcutaneous injections of olokizumab every 4 weeks, with doses of either 64 mg or 48 mg depending on body weight. The study includes a screening period up to 2 weeks, a main treatment period of 24 weeks, an extended treatment phase lasting up to week 164, and a safety follow-up lasting 22 weeks. The total participation time is about 188 weeks. During the study, participants will undergo assessments of drug concentration levels and response at various timepoints. Researchers will monitor joint activity, inflammation markers like C-reactive protein, and safety measures through laboratory tests. Outcome measures include maximum drug concentration and area under the concentration-time curve over 24 weeks. The study also tracks long-term safety and efficacy with regular evaluations throughout treatment and follow-up.

Pharmacokinetics, Efficacy and Safety of Olokizumab In Patients With Juvenile Idiopathic Arthritis