Sendenhorst

Researchers are studying the use of sarilumab, a drug given by injection, in children and adolescents aged 1 to 17 years who have systemic juvenile idiopathic arthritis sJIA. The study aims to understand how the drug behaves in the body, its effects, and its long-term safety for treating this condition. This trial is a phase 2, open-label study sponsored by Sanofi, designed to find the best dose and treatment schedule for young patients with sJIA. Participants will receive sarilumab injections under the skin at doses that increase during the study based on body weight. The treatment includes a 12-week core phase where patients receive the drug, followed by a 144-week extension phase for continued treatment. After completing treatment, a 6-week follow-up period will monitor patients. The study includes careful dose adjustments and long-term observation to assess the drugs impact. Throughout the study, participants will undergo various assessments including blood tests to measure drug levels, evaluations of disease activity using scales like the Investigator Global Assessment and ParentPatient Global Assessment, and tracking of symptoms and medication use. Safety will be monitored continuously by recording any side effects or local reactions to injections. The total participation time is about 166 weeks, during which the researchers will collect data on how well sarilumab works and how safe it is for children and adolescents with sJIA.

This research aims to evaluate the effectiveness and safety of AZD1163, a new bispecific antibody, in adults with moderately-to-severely active rheumatoid arthritis RA who are positive for anti-citrullinated peptide antibodies ACPA. The study focuses on patients who have had an inadequate or lost response or intolerance to certain standard treatments. The trial is a Phase II, randomized, double-blind, placebo-controlled study conducted at multiple centers to assess AZD1163s impact on RA disease activity. Participants will be randomly assigned to one of four groups to receive subcutaneous injections of either one of three doses of AZD1163 or a matching placebo. All participants will continue their standard care treatments, which may include conventional synthetic disease-modifying antirheumatic drugs csDMARDs or tumor necrosis factor inhibitors TNFi with or without csDMARDs. The treatment period lasts 24 weeks, followed by a 28-week safety follow-up phase. Throughout the study, participants will undergo assessments including disease activity scores such as DAS28-CRP, American College of Rheumatology response criteria ACR20 and ACR50, and clinical disease activity indexes. Researchers will also evaluate the pharmacokinetics and immunogenicity of AZD1163. Safety monitoring continues during the follow-up period, and total participation spans approximately 52 weeks.

Researchers are studying children aged 2 to under 18 years who have active juvenile enthesitis-related arthritis, including juvenile-onset ankylosing spondylitis, or juvenile psoriatic arthritis. The study aims to assess the levels of the drug bimekizumab in the blood after it is given by subcutaneous injection. This Phase 3 trial evaluates the safety and drug concentrations to better understand how bimekizumab behaves in pediatric participants with these specific types of juvenile arthritis. Participants will receive bimekizumab doses adjusted according to their weight, administered at specific times during the study. The initial treatment period lasts up to 16 weeks. The study also includes an extended safety follow-up of up to 141 weeks to monitor for any adverse events or side effects. No placebo or comparison group is used all participants receive the active drug. Throughout the study, participants will undergo regular assessments including blood tests to measure drug levels, vital signs, biochemistry and hematology parameters, growth measurements, and evaluations of arthritis disease activity. Researchers will also monitor adverse events, including specific infections and injection site reactions. The study tracks responses using standardized juvenile arthritis scores at Week 16. Participants are followed closely for safety and treatment effects throughout the treatment and follow-up periods, which may last several years.

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.