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

NCT07141004 | Recruiting Phase 4

• 1 other identifier: CNTO1959PSA4018
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 9

Brief Summary

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

Arthritis, Psoriatic

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Adverse Events (AEs)

  An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

  Up to 32 weeks

• Number of Participants With Serious Adverse Events (SAEs)

  A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.

  Up to 32 weeks

Secondary Outcomes (3)

• Percentage of Participants Who Achieve an American College of Rheumatology (ACR) 20 Response at Week 12

  Week 12

• Percentage of Participants Who Achieve an ACR 20 Response at Week 24

  Week 24

• Change From Baseline in Analytic Marker of Inflammation (CRP Levels) at Weeks 12 and 24

  Baseline, Weeks 12 and 24

Study Arms (1)

Guselkumab

EXPERIMENTAL

Participants will receive subcutaneous injections of guselkumab at Weeks 0, 4, 12, and 20.

Drug: Guselkumab

Interventions

Guselkumab DRUG

Guselkumab will be administered as subcutaneous injection.

Also known as: TREMFYA

Guselkumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Private Limited: lead

Study Sites (9)

Cims Hospital

Ahmedabad, 380060, India

RECRUITING

Chennai Meenakshi Multispeciality Hospital

Chennai, 600004, India

RECRUITING

All India Institute of Medical Sciences 1

Gorakhpur, 273008, India

RECRUITING

Nizams Institute of Medical Sciences

Hyderabad, 500082, India

RECRUITING

P. D. Hinduja National Hospital and Research Center

Mumbai, 400016, India

RECRUITING

All India Institute of Medical Sciences

New Delhi, 110029, India

RECRUITING

Sir Ganga Ram Hospital

New Delhi, 110060, India

RECRUITING

All India Institute of Medical Sciences

Patna, 801507, India

RECRUITING

Jehangir Clinical Development Centre

Pune, 4110001, India

RECRUITING

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 26, 2025
• Study Start: August 12, 2025
• Primary Completion (Estimated): June 5, 2027
• Study Completion (Estimated): September 11, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

IN (9)