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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohnson & Johnson Private Limited

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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]

Have no history of TB prior to screening AND

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Guselkumab

    Drug

    Guselkumab will be administered as subcutaneous injection.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: GuselkumabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 32 weeks
2

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.

Time frame
Up to 32 weeks

Secondary outcomes

1

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).

Time frame
Week 12
2

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.

Time frame
Week 24
3

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.

Time frame
Baseline, Weeks 12 and 24

Other outcomes

Sponsors and contacts

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