Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT07141004

A Study of Guselkumab Administered Subcutaneously in Treatment of Indian Participants With Psoriatic Arthritis (PsA)

Led by Johnson & Johnson Private Limited · Updated on 2026-05-08

100

Participants Needed

10

Research Sites

108 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to evaluate the safety and how well guselkumab treatment works (efficacy) in participants with psoriatic arthritis (PsA; a chronic, autoimmune form of arthritis that causes joint inflammation) who had inadequate response to standard therapies.

CONDITIONS

Official Title

A Study of Guselkumab Administered Subcutaneously in Treatment of Indian Participants With Psoriatic Arthritis (PsA)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Definite diagnosis of active psoriatic arthritis according to CASPAR criteria with at least one PsA subset
  • Negative for rheumatoid factors
  • Inadequate response to standard therapies for at least 3 months at the highest recommended doses, including biologics-na�ve or failed/intolerant to biological treatments
  • Meet tuberculosis screening criteria including no history or signs of active TB, negative TB tests within 6 weeks before treatment, and chest X-ray with no active or inactive TB within 3 months
  • Medically stable based on physical exam, medical history, vital signs, and ECG
  • Negative highly sensitive serum beta-hCG at screening for women of childbearing potential
Not Eligible

You will not qualify if you...

  • History of latent or active granulomatous infection prior to screening
  • Known serious allergy to guselkumab or its ingredients
  • Serious infection, hospitalization for infection, or IV antibiotic treatment within 2 months before first treatment
  • Known history of malignancy or lymphoproliferative disease
  • Received or expected to receive live virus or bacterial vaccines 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

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Trial Site Locations

Total: 10 locations

1

Cims Hospital

Ahmedabad, India, 380060

Actively Recruiting

2

Post Graduate Institute of Medical Education And Research PGIMER

Chandigarh, India

Actively Recruiting

3

Chennai Meenakshi Multispeciality Hospital

Chennai, India, 600004

Actively Recruiting

4

All India Institute of Medical Sciences 1

Gorakhpur, India, 273008

Actively Recruiting

5

Nizams Institute of Medical Sciences

Hyderabad, India, 500082

Actively Recruiting

6

P. D. Hinduja National Hospital and Research Center

Mumbai, India, 400016

Actively Recruiting

7

All India Institute of Medical Sciences

New Delhi, India, 110029

Actively Recruiting

8

Sir Ganga Ram Hospital

New Delhi, India, 110060

Actively Recruiting

9

All India Institute of Medical Sciences

Patna, India, 801507

Actively Recruiting

10

Jehangir Clinical Development Centre

Pune, India, 4110001

Actively Recruiting

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Research Team

S

Study Contact

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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