Guselkumab treatment for psoriatic arthritis in Indian participants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• ESIC Medical College and Hospital
  Hyderabad, India Recruiting
• Nizams Institute of Medical Sciences
  Hyderabad, India Recruiting

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• One-year guselkumab use in adults with psoriatic arthritis

  This project will see how long adults with psoriatic arthritis stay on guselkumab over one year when prescribed as part of routine care.

  Recruiting Janssen-Cilag Ltd. · Lille · NCT07532226

• Guselkumab for people with psoriatic arthritis in routine care

  This study will test whether guselkumab given in routine clinical care reduces joint inflammation in people with psoriatic arthritis using musculoskeletal ultrasound to track changes.

  Recruiting at 20 sites Janssen Research & Development, LLC · Bari and 20 other locations · NCT07220824

• Long-term evaluation of guselkumab for children with inflammatory bowel disease and juvenile arthritis

  This study tests how safe and effective the medication guselkumab is for children with inflammatory bowel disease or juvenile arthritis over a long period of time.

  Recruiting at 53 sites Phase 3 Janssen Research & Development, LLC · Atlanta, Georgia and 52 other locations · NCT06663332

• Long-Term Guselkumab Use in Adults with Inflammatory Bowel Disease

  This study looks at how long adults with Crohn's disease or ulcerative colitis stay on guselkumab in real-world care.

  Recruiting Janssen Research & Development, LLC · Amiens · NCT07822529

• Colonic delivery of two antibodies to see if they reach the bloodstream in healthy people

  This early study tests whether guselkumab and adalimumab given directly into the colon can enter the body in healthy adults.

  Recruiting Phase 1 Surmount Services, Inc. · Maroochydore, Queensland · NCT07788807

• Guselkumab after Ustekinumab in adults with moderate-to-severe psoriasis in routine care

  This study looks at how well guselkumab works for people with moderate-to-severe psoriasis after switching from ustekinumab in everyday clinical practice.

  Recruiting Janssen-Cilag Kft. · Budapest · NCT07746583

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.