Sendenhorst

The total study duration per patient will be 166 weeks that will consist of a 4- week screening, a 12-week core treatment phase, a 144-week extension phase, and a 6-week post-treatment follow-up.

Researchers are studying AZD1163, a new bispecific antibody, to assess its effectiveness and safety in adults with moderately-to-severely active rheumatoid arthritis (RA) who test positive for anti-citrullinated peptide antibodies (ACPA). This Phase II, randomized, double-blind, placebo-controlled trial involves participants already receiving standard treatments such as conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or tumor necrosis factor inhibitors (TNFi). Participants will be randomly assigned to one of four groups to receive subcutaneous injections of either one of three doses of AZD1163 or a placebo, alongside their standard care, for 24 weeks. Following this treatment period, there will be a 28-week safety follow-up to monitor participants. Throughout the study, researchers will evaluate changes from baseline in disease activity scores using C-reactive protein levels at 12 weeks. Participants will undergo regular assessments including joint counts and laboratory tests to monitor disease status and safety. The total involvement in the study spans over 52 weeks, including treatment and follow-up periods.

Researchers are evaluating the plasma concentrations of bimekizumab in children aged 2 to less than 18 years who have active juvenile idiopathic arthritis, specifically enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis. The study aims to understand how the drug behaves in the body when given by subcutaneous injection and to assess its safety in these pediatric participants. This is an open-label, single-arm Phase 3 trial focusing on these specific arthritis subtypes. Participants will receive bimekizumab injections at predetermined times during the study. The treatment period includes an initial phase up to 16 weeks where the drug levels in plasma will be monitored. Participants already taking methotrexate or sulfasalazine may continue these stable medications, but no other disease-modifying or immunosuppressive drugs are allowed during the study. The study does not require prior use of methotrexate or sulfasalazine and excludes participants who have received certain other biologic therapies. Throughout the study, children will be assessed for active joint involvement and enthesitis, and regular plasma sampling will be done to measure bimekizumab concentrations. Safety will be closely monitored, including evaluations for infections, laboratory tests, and mental health status. The study requires informed consent/assent and follows participants for the initial treatment period and beyond to ensure thorough monitoring of drug effects and safety.

Researchers are conducting the Avacostar PASS, a multi-national, non-interventional prospective cohort study to gather data on patients with active severe ANCA-associated vasculitis (AAV). The study compares two groups: patients treated with avacopan and those treated with cyclophosphamide or rituximab-based induction regimens without avacopan. The goal is to evaluate the incidence of specific medical events of special interest (MESIs) over a long-term period. The study is planned to last up to 7 years, including about 3 years for recruitment. Participants will be enrolled in Germany, the United Kingdom, and possibly other countries depending on avacopan availability and suitability. Patients starting induction treatment with avacopan or standard care within 6 months prior to enrollment may join the study. Data will be collected prospectively, with some retrospective data allowed if needed. Follow-up will continue for each patient until 4 years after the last participant is enrolled, with periodic data collection at routine clinic visits. During the study, researchers will collect data on participants' medical status, treatment, and safety events to monitor the incidence of MESIs. The primary outcome focuses on safety monitoring related to avacopan use in AAV. Participants will be observed regularly through their usual clinical care visits, ensuring ongoing assessment of treatment effects and safety over several years.

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.