Actively Recruiting
Phase 4 Study of Guselkumab Injections for Indian Adults With Psoriatic Arthritis Evaluating Safety and Effectiveness
Led by Johnson & Johnson Private Limited · Updated on 2026-07-31
100
Participants Needed
11
Research Sites
14 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of guselkumab treatment in adults with psoriatic arthritis PsA, a chronic autoimmune condition causing joint inflammation. This phase IV, open-label study focuses on Indian participants who have not responded adequately to standard therapies, including conventional drugs and biologics. The goal is to understand how well guselkumab works and how safe it is in this specific patient population. Participants will receive subcutaneous injections of guselkumab at Weeks 0, 4, 12, and 20. The study monitors participants up to 32 weeks to assess safety outcomes such as adverse events and serious adverse events. Researchers will also measure treatment effects by evaluating responses using the American College of Rheumatology ACR 20 criteria at Weeks 12 and 24, along with changes in inflammation markers like C-reactive protein CRP. During the study, participants will undergo regular assessments including physical exams, medical history reviews, vital signs, ECGs, and tuberculosis screenings before treatment. The study team will monitor safety and efficacy through scheduled visits corresponding with treatment weeks and follow-up periods. Participants will be observed for up to 32 weeks to track any side effects and treatment responses, ensuring comprehensive evaluation of guselkumabs impact.
CONDITIONS
Brief Title
A Study of Guselkumab Administered Subcutaneously in Treatment of Indian Participants With Psoriatic Arthritis (PsA)
Research Team
S
Study Contact
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