Study to demonstrate the efficacy (including inhibition of structural damage), safety and tolerability up to 2 years of secukinumab in Active Psoriatic Arthritis

INTERVENTION: Trade Name: COSENTYX Product Name: Secukinumab Product Code: AIN457 Pharmaceutical Form: Solution for injection in pre‐filled syringe INN or Proposed INN: Secukinumab CAS Number: 1229022‐83‐6 Current Sponsor code: AIN457 Other descriptive name: SECUKINUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150‐ Pharmaceutical form of the placebo: Solution for injection in pre‐filled syringe Route of administration of the placebo: Subcutaneous use CONDITION: Psoriatic Arthritis ; MedDRA version: 20.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859 Therapeutic area: Diseases [C] ‐ Musculoskeletal Diseases [C05] PRIMARY OUTCOME: Main Objective: To demonstrate that the efficacy of secukinumab 150 mg s.c. (with or without loading regimen) or 300 mg s.c. with loading regimen, at Week 16 is superior to placebo based on proportion of subjects with active PsA achieving American College of Rheumatology 20 (ACR20) response. Primary end point(s): American College of Rheumatology 20 (ACR20) response Secondary Objective: AIN=secukinumab; ‐Change from BSL Wk24 with AIN150mg (w/ or w/o loading) or 300mg (w/ loading) compared w/pbo for joint/bone structural damage (using; mTSS); ‐Efficacy of AIN150 mg (w/ or w/o loading), or 300 mg (w/ loading) at Wk16 compared w/pbo based on the proportion of subjects achieving:; •PASI75 response; •PASI90 response; ‐Efficacy of AIN150mg (w/ or w/o loading) or 300mg (w/ loading) at Wk16 compared w/pbo based on proportion of subjects achieving ACR50; ; ‐Improvement on AIN150mg (w/ or w/o loading)or 300mg(w/ loading) at Wk16 compared w/pbo for; •changes in HAQ‐DI relative to BSL; •for the disease activity assessed by the changes in DAS28‐CRP (utilizing hsCRP) relative to BSL; ‐Efficacy of AIN pooled regimen (150 mg w/ or w/o loading, 300mg w/ loading) at Wk16 compared w/pbo based on proportion of subjects w/ enthesitis or dactylitis in the subset of subjects who have enthesitis or dactylitis at BSL; ‐Safety/tolerability Timepoint(s) of evaluation of this end point: 16 weeks SECONDARY OUTCOME: Secondary end point(s): ‐Van der Heijde modified total Sharp score (a) ; ‐Psoriasis Area and Severity Index 75 (PASI75) response (b) ; ‐Psoriasis Area and Severity Index 90 (PASI90) response (b) ; ‐American College of Rheumatology 50 (ACR50) response (b) ; ‐Health assessment questionnaire disability index© (HAQ‐DI©) score (b) ; ‐Disease Activity Score for 28 joints (DAS28‐CRP) (b) ; ‐Enthesitis (b) ; ‐Dactylitis (b) Timepoint(s) of evaluation of this end point: a) 24 weeks ; b) 16 weeks INCLUSION CRITERIA: ‐Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months with moderate to severe PsA who must have at BSL =3 tender joints out of 78 and =3 swollen joints out of 76 (dactylitis of a digit counts as one joint each). ‐Rheumatoid factor (RF) and anti‐cyclic citrullinated peptide (anti‐CCP) antibodies negative at screening. ‐Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or a documented history of plaque psoriasis. ‐Subjects with PsA should have taken NSAIDs for at least 4 weeks prior to randomization with inadequate control of symptoms or at least one dose if stopped due to intolerance to NSAIDs. ‐Subjects taking corticosteroids must be on a stable dose of =10 mg/day prednisone o ‐Subjects who are regularly taking NSAIDs as part of their PsA therapy are required to be on a stable dose for at least 2 weeks before study randomization and should remain on a stable dose up to Week 24.