Bregenz

This research aims to evaluate the long-term safety and effectiveness of the drug baricitinib in treating juvenile idiopathic arthritis JIA in children and adolescents aged 1 to under 18 years. Participants in this study have previously taken part in other baricitinib studies for JIA. The purpose is to monitor how well baricitinib works and to assess any serious side effects over an extended period. Participants will receive baricitinib orally during the study. This is a single-group trial where all participants receive the same treatment. The study follows participants for a total duration of up to 264 weeks approximately 5 years, during which they will be monitored closely for safety and disease activity. Throughout the study, participants will have regular assessments including monitoring for serious adverse events and treatment discontinuations. Researchers will also evaluate disease activity, pain levels, and other health measures using various clinical tools at baseline and at the end of the study period. This long-term follow-up ensures thorough evaluation of baricitinibs impact and participant well-being.

Researchers are evaluating the effectiveness of apremilast compared with placebo for treating children aged 5 to less than 18 years with active juvenile psoriatic arthritis JPsA. This phase 3, double-blind, randomized, placebo-controlled study aims to assess how well apremilast works in improving symptoms and disease activity in pediatric participants with JPsA. Participants will be randomly assigned to receive either apremilast or a matching placebo orally during a 16-week double-blind treatment phase. After this period, all participants will continue with apremilast treatment for an additional 36 weeks in an open-label phase. The study will monitor the safety, efficacy, and pharmacokinetics of apremilast throughout these treatment periods. Participants will undergo regular assessments including evaluations of joint activity, pain levels, physician and participant disease activity ratings, and laboratory markers of inflammation. Researchers will measure responses using the American College of Rheumatology Pediatric ACR Pedi criteria and other disease activity scores. Safety monitoring includes tracking treatment-emergent adverse events and suicidal ideation. The study lasts a total of 52 weeks, with evaluations of growth and development included during the later weeks.

Juvenile Idiopathic Arthritis JIA is a common chronic arthritis in children, with systemic JIA sJIA being a rare, severe type that affects joints and other organs like the liver, lungs, and heart. This trial evaluates how safe and effective the drug upadacitinib is in treating children and adolescents aged 1 to under 18 years with active sJIA. The study also includes a tocilizumab treatment group for comparison, assessing adverse events and changes in disease activity. Participants are assigned to one of two groups Cohort 1 receives either upadacitinib or tocilizumab, while Cohort 2 receives upadacitinib only. Upadacitinib is given daily as oral tablets or oral solution, and tocilizumab is administered via subcutaneous injection or intravenous infusion according to local guidelines. Treatment lasts for 52 weeks, followed by about 30 days of monitoring after treatment ends. During the study, participants will attend regular hospital or clinic visits or calls for medical assessments, side effect monitoring, and questionnaires. Researchers will measure disease activity changes, adverse events, and how the drugs move through the body. The main outcomes include the percentage of participants achieving specific responses in sJIA disease activity by week 12 and reporting adverse events up to week 52.