Arthritis, PsoriaticPhase 4NCT07141004
A Study of Guselkumab Administered Subcutaneously in Treatment of Indian Participants With Psoriatic Arthritis (PsA)
A Phase 4 study testing Guselkumab in people with Arthritis, Psoriatic, run by Johnson & Johnson Private Limited at 11 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Psoriatic
- What is being tested?
- Guselkumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 11 sitesIndia
- Study dates
- 12 Aug 2025to 11 Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
India11 sites, 11 recruiting
- Recruiting
Cims Hospital
Ahmedabad, 380060
- Recruiting
Post Graduate Institute of Medical Education And Research PGIMER
Chandigarh
- Recruiting
Chennai Meenakshi Multispeciality Hospital
Chennai, 600004
- Recruiting
All India Institute of Medical Sciences 1
Gorakhpur, 273008
- Recruiting
ESIC Medical College and Hospital
Hyderabad, 500038
- Recruiting
Nizams Institute of Medical Sciences
Hyderabad, 500082
- Recruiting
P. D. Hinduja National Hospital and Research Center
Mumbai, 400016
- Recruiting
All India Institute of Medical Sciences
New Delhi, 110029
- Recruiting
Sir Ganga Ram Hospital
New Delhi, 110060
- Recruiting
All India Institute of Medical Sciences
Patna, 801507
- Recruiting
Jehangir Clinical Development Centre
Pune, 4110001
About this study
Official title: 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.
- Conditions
- Arthritis, Psoriatic
- Being tested
- Guselkumab
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GuselkumabDrug
Also called TREMFYA
Guselkumab will be administered as subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| Guselkumab | Experimental | Participants will receive subcutaneous injections of guselkumab at Weeks 0, 4, 12, and 20. Receives: Drug: Guselkumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 32 weeks
Secondary outcomes (3)
Percentage of Participants Who Achieve an American College of Rheumatology (ACR) 20 Response at Week 12
ACR 20 Response is defined as greater than or equal to (>=) 20 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent (%) improvement from baseline in 3 of following 5 assessments: 1) participant's assessment of pain using Visual Analog Scale (VAS; 0-100 millimeter [mm], 0 mm=no pain and 100 mm=worst possible pain), 2) participant's global assessment of disease activity by VAS scale range: 0 mm= very well to 100 mm= very poor, 3) physician's global assessment of disease activity using VAS (scale ranges from 0 = no arthritis to 100 = extremely active arthritis), 4) participant's assessment of physical function measured by Health Assessment Questionnaire-disability Index (HAQ-DI). The derived HAQ-DI ranges from 0 indicating no difficulty to 3 indicating inability to perform a task in that area, and 5) C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR).
Measured: Week 12
Percentage of Participants Who Achieve an ACR 20 Response at Week 24
ACR 20 Response is defined as >= 20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and >=20% improvement from baseline in 3 of following 5 assessments: 1) participant's assessment of pain using VAS (0-100 mm, 0 mm=no pain and 100 mm=worst possible pain), 2) participant's global assessment of disease activity by using VAS (scale range: 0 mm= very well to 100 mm= very poor), 3) physician's global assessment of disease activity using VAS (scale ranges from 0 = no arthritis to 100 = extremely active arthritis), 4) participant's assessment of physical function measured by HAQ-DI. The derived HAQ-DI ranges from 0 indicating no difficulty to 3 indicating inability to perform a task in that area, and 5) CRP and ESR.
Measured: Week 24
Change From Baseline in Analytic Marker of Inflammation (CRP Levels) at Weeks 12 and 24
CRP levels that is the analytic markers of inflammation will be assessed.
Measured: Baseline, Weeks 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start12 Aug 2025
- Primary completion5 Jun 2027 (estimated)
- Study completion11 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, PsoriaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Private Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141004
- Sponsor's protocol ID
- CNTO1959PSA4018
- Other IDs
- CNTO1959PSA4018
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07141004
- Acronym / sponsor ID
- CNTO1959PSA4018
- Conditions
- Arthritis, Psoriatic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Johnson & Johnson Private LimitedIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 5 Jun 2027 (estimated)
- Study completion
- 11 Sep 2027 (estimated)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Guselkumab | Experimental | Drug: GuselkumabParticipants will receive subcutaneous injections of guselkumab at Weeks 0, 4, 12, and 20. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- Medically stable on the basis of physical examination, medical history, vital signs, and 12-lead ECG
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GuselkumabAlso: TREMFYAGuselkumab will be administered as subcutaneous injection. | Drug | Guselkumab |
Primary outcome
Number of Participants With Adverse Events (AEs)
Time frame: Up to 32 weeks
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.
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to 32 weeks
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.
3 secondary outcomes
Percentage of Participants Who Achieve an American College of Rheumatology (ACR) 20 Response at Week 12
Time frame: Week 12
Percentage of Participants Who Achieve an ACR 20 Response at Week 24
Time frame: Week 24
Change From Baseline in Analytic Marker of Inflammation (CRP Levels) at Weeks 12 and 24
Time frame: Baseline, Weeks 12 and 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: Yes. The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Guselkumab in people with Arthritis, Psoriatic, run by Johnson & Johnson Private Limited at 11 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs) (time frame: Up to 32 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.