Bregenz

Researchers are evaluating the long-term safety and effectiveness of baricitinib for treating Juvenile Idiopathic Arthritis (JIA) in children and teenagers aged 1 to less than 18 years. This phase 3 study focuses on participants who have previously taken part in baricitinib studies I4V-MC-JAHV or I4V-MC-JAHU. The goal is to monitor how well baricitinib works and how safe it is over an extended period in this young population. Participants will receive baricitinib orally as part of the study treatment. Since all participants have prior exposure to baricitinib in earlier studies, this trial continues to observe their response and any long-term effects. The study does not mention a separate comparator group or additional interventions beyond baricitinib administration. During the study, researchers will track serious adverse events and any permanent discontinuations of baricitinib from the start through week 264. Participants will be regularly monitored for safety and treatment effects throughout this long-term follow-up. This extended observation helps assess the ongoing impact of baricitinib on juvenile arthritis over several years.

Researchers are evaluating the effectiveness of apremilast compared with a placebo in treating juvenile psoriatic arthritis (JPsA) in children aged 5 to less than 18 years. This phase 3, multicenter, double-blind, randomized, placebo-controlled study aims to assess the safety, efficacy, and drug behavior in pediatric participants with active JPsA, a condition involving arthritis and psoriasis or related symptoms. Participants will be randomly assigned to receive either oral apremilast or a matching oral placebo. The study will monitor the response to treatment over a 16-week period, focusing on achieving a specific improvement based on American College of Rheumatology Pediatric (ACR Pedi 30) criteria. Both treatments will be administered during this time to compare their effects. During the study, children will be regularly assessed for joint activity and disease symptoms. Researchers will measure the number of participants achieving the ACR Pedi 30 response by week 16 to evaluate treatment effectiveness. Safety and pharmacokinetics will also be monitored throughout, with the total participation duration covering the initial 16 weeks of treatment observation.

Juvenile Idiopathic Arthritis (JIA) is a common chronic arthritis affecting children, with systemic JIA (sJIA) being a rare and more severe form that can impact joints and other organs like the liver, lungs, and heart. This research evaluates the safety and effectiveness of the investigational drug upadacitinib in treating children and adolescents aged 1 to under 18 years with active sJIA. The study also includes a treatment arm using tocilizumab for comparison, focusing on disease activity changes and adverse events. Participants are assigned to one of two groups: Cohort 1 receives either upadacitinib or tocilizumab, while Cohort 2 receives upadacitinib alone. Upadacitinib is given as oral tablets once daily or oral solution twice daily. Tocilizumab is administered as subcutaneous injections or intravenous infusions according to local guidelines. Treatment lasts for 52 weeks, followed by about 30 days of monitoring. During the study, participants will attend regular hospital or clinic visits or calls for medical assessments, side effect monitoring, and questionnaires. Researchers will measure the percentage of participants achieving a specific improvement in sJIA symptoms at week 12 and track adverse events up to week 52. About 90 participants from approximately 45 sites worldwide are expected to join the study, which may require more commitment than standard care.