Tests guselkumab injections in Indian adults with psoriatic arthritis
Tests guselkumab, given under the skin, in adults with psoriatic arthritis who had poor response.
Plain-language title generated from the registry record
Registry title: A Study of Guselkumab Administered Subcutaneously in Treatment of Indian Participants With Psoriatic Arthritis (PsA)
Key facts
- Where
- Ahmedabad, Chandigarh, Chennai, Gorakhpur, Hyderabad, Mumbai, New Delhi, Patna, and Pune, IndiaSee the 11 sites
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults in India with active psoriatic arthritis who did not respond well enough to standard treatments. All receive guselkumab by injection under the skin.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Active psoriatic arthritis, confirmed by the CASPAR criteria, with at least 1 of these types: arthritis in the end finger or toe joints, arthritis in many joints without rheumatoid nodules, arthritis mutilans, uneven arthritis in the limbs, or spine arthritis with limb joint arthritis. Swollen or tender joints must be present.
- Earlier treatment
- Standard treatment for 3 months at the highest dose did not work well enough (for example methotrexate, apremilast or NSAIDs). People who never had biologic drugs can join. People who had biologics (anti-TNF or IL-17 blockers) that failed or were not tolerated can also join.
- Biomarker or test result
- Negative for rheumatoid factor. Tuberculosis screening: negative QuantiFERON-TB Gold and skin test within 6 weeks, or active TB ruled out with treatment for latent TB started. A chest X-ray within 3 months must show no current or old TB.
Main reasons for not taking part
- History of latent or active granulomatous infection
- Known serious allergy to guselkumab or its ingredients
- Serious infection, hospital stay or IV antibiotics for infection within 2 months
- Any current or past cancer or lymphoproliferative disease
- Live virus or bacterial vaccine within 3 months before the first dose
Read by machine on 9 November 2026.
Where in India
- Cims HospitalAhmedabad, IndiaTaking people
- Post Graduate Institute of Medical Education and Research (PGIMER)Chandigarh, IndiaTaking people
- Chennai Meenakshi Multispeciality HospitalChennai, IndiaTaking people
- All India Institute of Medical Sciences 1Gorakhpur, IndiaTaking people
- ESIC Medical College and HospitalHyderabad, IndiaTaking people
- Nizams Institute of Medical SciencesHyderabad, IndiaTaking people
- P. D. Hinduja National Hospital and Research CenterMumbai, IndiaTaking people
- All India Institute of Medical SciencesNew Delhi, IndiaTaking people
- Sir Ganga Ram HospitalNew Delhi, IndiaTaking people
- All India Institute of Medical SciencesPatna, IndiaTaking people
- Jehangir Clinical Development CentrePune, IndiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Johnson & Johnson Private Limited
- Trial code
- NCT07141004
- Record updated
- 28 August 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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:; Have no history of TB prior to screening AND; Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination AND; 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; 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; 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: History of latent or active granulomatous infection prior to screening; 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; 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; Have a known clinically significant hypersensitivity to guselkumab or to any of the excipients; Has any known malignancy or has a history of malignancy, or a history of lymphoproliferative disease.