Guselkumab treatment for psoriatic arthritis in Indian participants

A Phase-IV, Multicenter, Non-Comparative, Open-Label Study Evaluating the Safety and Efficacy of Guselkumab Administered Subcutaneously in the Treatment of Indian Patients With Psoriatic Arthritis

This tests whether guselkumab injections are safe and can help Indian patients with psoriatic arthritis who have not improved with standard treatments.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Johnson & Johnson Private Limited (Industry-sponsored)
• Drugs / interventions: guselkumab, methotrexate
• Locations: 10 sites (Ahmedabad and 9 other locations)
• Trial ID: NCT07141004 on ClinicalTrials.gov

What this trial studies

This Phase 4 interventional study gives subcutaneous guselkumab to adults in India with active psoriatic arthritis who meet CASPAR criteria and have had inadequate response to standard therapies. Participants may be biologic-naïve or have failed or been intolerant to one or more biologic treatments. The trial will monitor safety and measures of arthritis activity and symptoms over the treatment period at participating Indian hospitals. Data will be collected to characterize how well the drug works and its safety profile in this specific population.

Who should consider this trial

Good fit: Adults in India with active psoriatic arthritis meeting CASPAR criteria, who are rheumatoid factor negative and have had inadequate response to standard therapies for at least three months (including those who are biologic-naïve or who failed or were intolerant to biologics).

Not a fit: People whose arthritis is well controlled with standard therapies, those with a different form of arthritis (for example rheumatoid arthritis with positive rheumatoid factor), or those who do not meet the study's eligibility criteria are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, guselkumab could reduce joint pain and swelling and improve function for patients with psoriatic arthritis who have not responded to standard therapies.

How similar studies have performed: Previous randomized trials of guselkumab (for example the DISCOVER programs) have shown efficacy in psoriatic arthritis, so this study builds on existing positive evidence.

Eligibility criteria

Inclusion Criteria:

* Participants who have definite diagnosis of active psoriatic arthritis (PsA) (according to the ClASsification criteria for Psoriatic Arthritis \[CASPAR\]) prior to the first administration of study drug and have at least 1 of the PsA subsets: distal interphalangeal joint arthritis, polyarticular arthritis with the absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
* Participants who are negative for rheumatoid factors
* Participants having inadequate response (defined by presence of active arthritis \[presence of any swollen or any tender joint\]) to standard therapies for 3 months at the highest recommended dose (e.g., conventional disease-modifying antirheumatic drugs \[DMARDs\] including methotrexate, apremilast, or nonsteroidal anti-inflammatory drugs \[NSAIDs\]), including biologics naïve patient or have failed, or were intolerant to one or more biological treatments \[anti-TNF/IL-17i\]
* Participants are considered eligible per the following Tuberculosis (TB) screening criteria:

  1. Have no history of TB prior to screening AND
  2. Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination AND
  3. Have had no recent close contact with a person with active TB, or if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study drug AND
  4. Within 6 weeks prior to the first administration of study drug, have a negative QuantiFERON- TB Gold and a negative tuberculin skin test result, OR have a newly identified positive QuantiFERON-TB Gold or tuberculin skin test result during screening in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study drug AND
  5. Have a chest radiograph (both posterior-anterior and lateral views), taken within 3 months prior to the first administration of study drug and read by a qualified radiologist, with no evidence of current active TB or old inactive TB
* Medically stable on the basis of physical examination, medical history, vital signs, and 12-lead ECG
* A woman of childbearing potential must have a negative highly sensitive serum beta-hCG at screening visit

Exclusion Criteria:

* History of latent or active granulomatous infection prior to screening
* Have a known clinically significant hypersensitivity to guselkumab or to any of the excipients
* Have had a serious infection, or have been hospitalized for an infection, or have been treated with intravenous (IV) antibiotics for an infection within 2 months prior to first administration of study intervention
* Has any known malignancy or has a history of malignancy, or a history of lymphoproliferative disease
* Have received, or are expected to receive, any live virus or bacterial vaccination within 3 months before the first administration of study intervention, during the study, or within 6 months after the last administration of study intervention

Where this trial is running

Ahmedabad and 9 other locations

• Cims Hospital — Ahmedabad, India (Recruiting)
• Post Graduate Institute of Medical Education And Research PGIMER — Chandigarh, India (Recruiting)
• Chennai Meenakshi Multispeciality Hospital — Chennai, India (Recruiting)
• All India Institute of Medical Sciences 1 — Gorakhpur, India (Recruiting)
• Nizams Institute of Medical Sciences — Hyderabad, India (Recruiting)
• P. D. Hinduja National Hospital and Research Center — Mumbai, India (Recruiting)
• All India Institute of Medical Sciences — New Delhi, India (Recruiting)
• Sir Ganga Ram Hospital — New Delhi, India (Recruiting)
• All India Institute of Medical Sciences — Patna, India (Recruiting)
• Jehangir Clinical Development Centre — Pune, India (Recruiting)

Study contacts

• Study coordinator: Study Contact

Conditions Arthritis, Psoriatic