A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled trial of Ustekinumab, a Fully Human anti-IL-12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Psoriatic Arthritis Including Those Previously Treated with Biologic Anti-TNFa Agent(s) - PSUMMIT II

INTERVENTION:

Trade Name: Stelara Product Name: ustekinumab Product Code: CNTO1275 Pharmaceutical Form: Solution for injection Current Sponsor code: ustekinumab Other descriptive name: Human Anti‐IL‐12 Antibody Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use

CONDITION:

Psoriatic arthritis ; MedDRA version: 12.1 Level: LLT Classification code 10037160 Term: Psoriatic arthritis

PRIMARY OUTCOME:

Main Objective: The primary objectives of this study are to evaluate the efficacy of ustekinumab in subjects with active PsA including those previously treated with biologic anti‐TNFa agent(s) by assessing the reduction in signs and symptoms of PsA and to evaluate the safety of ustekinumab in this population. Primary end point(s): The primary endpoint is the proportion of subjects achieving an ACR 20 response at Week 24. Secondary Objective: The secondary objectives of this study are to evaluate the efficacy of ustekinumab in:; 1. Improving physical function;; 2. Improving psoriatic skin lesions; and; 3. Inhibiting the progression of structural damage.

INCLUSION CRITERIA:

• Men or women between 18 and 99 years of age, inclusive. • Have had PsA at least 6 months prior to the first administration of study agent. • Have a diagnosis of active PsA as defined by: – 5 or more swollen joints and 5 or more tender joints at screening and at baseline ‐AND‐ – C‐reactive protein (CRP) = 0.3 mg/dL at screening. • Have at least 1 of the PsA subsets: • Have active plaque psoriasis or a documented history of plaque psoriasis. • Have active PsA despite current or previous DMARD and/or NSAID therapy. • Subjects previously treated with a biologic anti‐ TNFa agent, must have: – received at least an 8‐week dosage regimen of etanercept, adalimumab, golimumab, or certolizumab pegol; or – received at least a 14‐week dosage regimen of infliximab; or – received less than an 8‐week dosage regimen of etanercept, adalimumab, golimumab, or certolizumab pegol or less than a 14‐week dosage regimen of infliximab