Treatment Study Using New Assessment Tool STAR in Adults With Primary Sjgrens Syndrome Comparing Combination Immunomodulatory Drugs Targeting B- and T-cells

What this Trial Is About

Primary Sjf6grens syndrome pSS is an autoimmune disease primarily affecting exocrine glands, causing dryness, joint pain, and fatigue, with some patients experiencing more severe systemic symptoms and higher risk of lymphoma. This trial aims to evaluate a new combined treatment targeting both B- and T-cells using a novel clinical endpoint called STAR, designed to better measure treatment response in pSS patients. The study involves two patient groups based on disease activity and symptoms. Each group receives one of three treatments daily for 24 weeks placebo pills, a combination of Leflunomide and hydroxychloroquine with placebo Mycophenolate mofetil, or Mycophenolate mofetil combined with hydroxychloroquine and placebo Leflunomide. The trial is randomized and triple-blinded to fairly compare these combinations targeting immune cells. Participants will be monitored over 24 weeks with assessments focusing on response measured by the STAR tool. Researchers will evaluate how many patients achieve a treatment response compared to placebo. Safety and disease activity will be tracked through clinical evaluations and laboratory tests. The study started in 2022 and aims to finish by 2025, with ongoing monitoring throughout the treatment period.

New Clinical End-points in Patients With Primary Sjögren's Syndrome