Actively Recruiting
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
On this page
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 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 important 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.
CONDITIONS
Brief Title
A Study of Guselkumab Administered Subcutaneously in Treatment of Indian Participants With Psoriatic Arthritis (PsA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Definite diagnosis of active psoriatic arthritis according to CASPAR criteria
- At least one psoriatic arthritis subtype present
- Negative for rheumatoid factors
- Inadequate response to standard therapies for at least 3 months at highest recommended doses
- No history or signs of active tuberculosis and meet specific TB screening criteria
- Medically stable based on physical exam, medical history, vital signs, and ECG
- Women of childbearing potential must have a negative serum beta-hCG at screening
You will not qualify if you...
- History of latent or active granulomatous infection
- Known hypersensitivity to guselkumab or its components
- Serious infection or hospitalization for infection within 2 months before treatment
- Known malignancy or history of malignancy or lymphoproliferative disease
- Received or expected to receive live virus or bacterial vaccination within 3 months before, during, or 6 months after study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 20 weeks
Participants receive subcutaneous injections of guselkumab to treat psoriatic arthritis.
4 visits at Weeks 0, 4, 12, and 20 (in-person)
Duration - Up to 12 weeks after treatment
Participants are monitored for safety and efficacy after the last treatment dose.
Visits up to Week 32 (in-person)
Trial Site Locations
Total: 10 locations
1
Cims Hospital
Ahmedabad, India, 380060
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2
Post Graduate Institute of Medical Education And Research PGIMER
Chandigarh, India
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3
Chennai Meenakshi Multispeciality Hospital
Chennai, India, 600004
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4
All India Institute of Medical Sciences 1
Gorakhpur, India, 273008
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5
Nizams Institute of Medical Sciences
Hyderabad, India, 500082
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6
P. D. Hinduja National Hospital and Research Center
Mumbai, India, 400016
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7
All India Institute of Medical Sciences
New Delhi, India, 110029
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8
Sir Ganga Ram Hospital
New Delhi, India, 110060
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9
All India Institute of Medical Sciences
Patna, India, 801507
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10
Jehangir Clinical Development Centre
Pune, India, 4110001
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Research Team
S
Study Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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