Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Active Psoriatic Arthritis (PsA)

INTERVENTION:

Product Name: Guselkumab Product Code: CNTO1959 Pharmaceutical Form: Solution for injection in pre‐filled syringe INN or Proposed

INN:

Guselkumab Current Sponsor code: CNTO1959 Other descriptive name: GUSELKUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100‐ Pharmaceutical form of the placebo: Solution for injection in pre‐filled syringe Route of administration of the placebo: Subcutaneous use Trade Name: Stelara Product Name: Ustekinumab Product Code: CNTO1275 Pharmaceutical Form: Solution for injection in pre‐filled syringe INN or Proposed

INN:

Ustekinumab CAS Number: 815610‐63‐0 Current Sponsor code: CNTO1275 Other descriptive name: USTEKINUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90‐ Trade Name: Stelara Product Name: Ustekinumab Product Code: CNTO1275 Pharmaceutical Form: Solution for injection in pre‐filled syringe INN or Proposed

INN:

Ustekinumab CAS Number: 815610‐63‐0 Current Sponsor code: CNTO1275 Other descriptive name: USTEKINUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90‐

CONDITION:

Active Psoriatic Arthritis ; MedDRA version: 18.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859 Therapeutic area: Diseases [C] ‐ Musculoskeletal Diseases [C05]

PRIMARY OUTCOME:

Main Objective: ‐ To evaluate the efficacy of guselkumab in subjects with active PsA by assessing the reduction in signs and symptoms of PsA.; ‐ To assess the safety and tolerability of guselkumab in subjects with active PsA. Primary end point(s): Percentage of Participants who Achieve an American College of Rheumatology (ACR) 20 Response at Week 24 Secondary Objective: The secondary objectives are:; ‐ To evaluate the efficacy of guselkumab in improving physical function.; ‐ To evaluate the impact of guselkumab on quality of life.; ‐ To evaluate the efficacy of guselkumab on psoriatic skin lesions.; ‐ To evaluate the PK and immunogenicity of guselkumab in subjects with active PsA.; ‐ To evaluate the PD characteristics of guselkumab with and without MTX in subjects with active PsA.; ‐ To evaluate the efficacy and safety of guselkumab following 1 year of exposure.; ; The exploratory objectives are:; ‐ To evaluate the correlation between PK and PD characteristics of guselkumab in subjects with PsA.; ‐ To use ultrasound to evaluate the changes in musculoskeletal abnormalities (enthesitis, tenosynovitis, and synovitis) from baseline in patients with active PsA treated with guselkumab as compared to placebo) Timepoint(s) of evaluation of this end point: Week 24

SECONDARY OUTCOME:

Secondary end point(s): 1. Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ‐DI) Score at Week 24 ; 2. Percentage of Participants who Achieve an American College of Rheumatology (ACR) 20 Response at Week 16 ; 3. Percentage of Participants who Achieve an ACR 50 Response at Week 24 ; 4. Percent Improvement in Enthesitis Scores at Week 24 Among Participants with Enthesitis at Baseline ; 5. Percent Improvement in Dactylitis Scores at Week 24 Among Participants with Dactylitis at Baseline ; ‐ secundairy end point 2 at week 16 ; ‐ secundairy end point 3 & 6 at week 24 ‐ Has plaque psoriasis with body surface area (BSA) involvement greater than or equal to (>=) 3% at Screening and baseline ‐ Has active PsA despite current or previous non‐biologic diseasemodifying antirheumatic drugs (DMARD), oral corticosteroid, and/or nonsteroidal anti‐inflammatory drug ( ; 6. Percentage of Participants who Achieve a Psoriatic Area and Severity Index (PASI) 75 Response at Week 24 Timepoint(s) of evaluation of this end point: ‐ secundairy end point 1, 4 & 5 at baseline & week 24

INCLUSION CRITERIA:

‐ Has had Psoriatic Arthritis (PsA) for at least 6 months before the first administration of study drug and meet classification criteria for Psoriatic Arthritis (CASPAR) at Screening ‐ Had active PsA as defined by: a. At least 3 swollen joints and at least 3 tender joints at Screening and at baseline b. C‐reactive protein (CRP) greater than or equal to (>=) 0.3 milligram (mg)/deciliter (dL) at Screening from the central laboratory ‐ Has at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis