A Phase IV, Open-Label Study Evaluating Safety and Efficacy of Subcutaneous Guselkumab in Indian Patients With Psoriatic Arthritis
Led by Johnson & Johnson Private Limited
Updated on 2026-06-05
100
Participants Needed
10
Research Sites
14 weeks
Total Duration
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What This Trial Is About
Researchers are evaluating the safety and effectiveness of guselkumab treatment in adults with psoriatic arthritis PsA, a chronic autoimmune disease causing joint inflammation. This Phase IV, open-label study focuses on Indian patients whose arthritis symptoms have not adequately improved with standard treatments. The study aims to gather significant information on adverse events and how well the treatment works in this specific group.
Participants will receive guselkumab through subcutaneous injections given at Weeks 0, 4, 12, and 20. This treatment schedule is designed to assess the response over a period of time. The study does not include a comparison group and is open-label, meaning both researchers and participants know the treatment being given. During the study, participants will be monitored for safety by recording any adverse events up to 32 weeks. Effectiveness will be measured by response rates at Weeks 12 and 24 and changes in inflammation markers CRP levels. Regular assessments will include physical exams, medical history, vital signs, and laboratory tests. The total participation period extends up to approximately 32 weeks, with close follow-up to evaluate both safety and treatment impact.
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Brief Title
A Study of Guselkumab Administered Subcutaneously in Treatment of Indian Participants With Psoriatic Arthritis (PsA)
Who Can Participate
Age: 18Years +
All Genders
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📌 A Phase IV, Open-Label Study Evaluating Safety And Efficacy Of Subcutaneous Guselkumab In Indian Patients With Psoriatic Arthritis (Ahmedabad)
🏢 DecenTrialz
📍 Ahmedabad
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