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Found 2 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the short-term and long-term safety and effectiveness of belimumab in adults diagnosed with early systemic lupus erythematosus (SLE) who have positive autoantibodies and continue to have active disease despite stable initial treatment. This phase 4, prospective, open-label study aims to describe how belimumab works in this specific group over a three-year period. Participants will receive belimumab (GSK1550188) administered by subcutaneous injection. There is one treatment arm where all participants will receive this drug. The study lasts for three years, during which participants will be regularly monitored to assess disease activity and treatment safety. During the study, participants will undergo various assessments including clinical evaluations to measure disease activity, laboratory tests, and questionnaires to track health status. The main outcome is the percentage of participants who achieve Lupus Low Disease Activity State (LLDAS) by week 52. Safety and efficacy will be closely monitored throughout the study period, with follow-up visits and evaluations scheduled at regular intervals.

Age: 18Years +All GendersPhase 4
113 locations
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Actively Recruiting

Researchers are evaluating the efficacy and safety of Afimkibart (also known as RO7790121) compared with a placebo in adults with moderate to severe rheumatoid arthritis (RA) who have not responded adequately or cannot tolerate tumor necrosis factor (TNF) and/or Janus kinase (JAK) inhibitors. This Phase II, multicenter, double-blind, placebo-controlled study focuses on participants who have active RA with specific joint swelling and tenderness, and who meet established RA classification criteria. Participants will receive either Afimkibart or placebo administered as a subcutaneous injection. The treatments are given to compare how well Afimkibart works against the placebo in reducing disease activity in RA patients with an inadequate response or intolerance to prior treatments. The study carefully monitors responses over a fixed timeline, including evaluations at baseline and Week 14. During the study, participants will undergo assessments measuring changes in the Disease Activity Score-28 for Rheumatoid Arthritis with C-Reactive Protein (DAS28-CRP) from baseline to Week 14. Researchers will monitor safety and efficacy through physical exams, laboratory tests, and other clinical evaluations. The study excludes individuals with certain prior treatments or medical conditions to ensure participant safety and reliable results.

Age: 18Years +All GendersPhase 2
46 locations