A Study of Guselkumab Administered Subcutaneously in Treatment of Indian Participants With Psoriatic Arthritis (PsA)
NCT ID: NCT07141004
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
100 participants
INTERVENTIONAL
2025-08-12
2027-09-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Guselkumab
Participants will receive subcutaneous injections of guselkumab at Weeks 0, 4, 12, and 20.
Guselkumab
Guselkumab will be administered as subcutaneous injection.
Interventions
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Guselkumab
Guselkumab will be administered as subcutaneous injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Johnson & Johnson Private Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Cims Hospital
Ahmedabad, , India
Chennai Meenakshi Multispeciality Hospital
Chennai, , India
Nizams Institute of Medical Sciences
Hyderabad, , India
P. D. Hinduja National Hospital and Research Center
Mumbai, , India
All India Institute of Medical Sciences
New Delhi, , India
Sir Ganga Ram Hospital
New Delhi, , India
Jehangir Clinical Development Centre
Pune, , India
Countries
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Central Contacts
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Other Identifiers
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CNTO1959PSA4018
Identifier Type: OTHER
Identifier Source: secondary_id
CNTO1959PSA4018
Identifier Type: -
Identifier Source: org_study_id