Psoriatic Arthritis MedDRA version: 20.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859
Conditions
Interventions
Trade Name: COSENTYX
Product Name: Cosentyx
Product Code: AIN457
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN o
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
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 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. -Subjects taking corticosteroids must be on a stable dose of =10 mg/day prednisone or equivalent for at least 2 weeks before randomization and should remain on a stable dose up to Week 24. -Subjects taking MTX (= 25 mg/week) are allowed to continue their medication if the dose is stable for at least 4 weeks before randomization and should remain on a stable dose up to Week 52. -Subjects on MTX must be on folic acid supplementation at randomization. -Subjects who are on a DMARD other than MTX must discontinue the DMARD 4 weeks prior to randomization visit except for leflunomide, which has to be discontinued for 8 weeks prior to randomization unless a cholestyramine wash-out has been performed. -Subjects who have been on a TNFa inhibitor must have experienced an inadequate response to previous or current treatment with a TNFa inhibitor given at an approved dose for at least 3 months or have stopped treatment due to safety/tolerability problems after at least one administration of a TNFa inhibitor. -Subjects who have previously been treated with TNFa inhibitors (investigational or approved) will be allowed entry into study after appropriate wash-out period prior to randomization. -Other protocol-defined inclusion criteria may apply. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 920 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: -Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process. -Subjects taking high potency opioid analgesics. -Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor. -Ongoing use of prohibited psoriasis treatments / medications (e.g., topical corticosteroids, UV therapy) at randomization. -Any intramuscular or intravenous or intra-articular corticosteroid treatment within 4 weeks before randomization. -Subjects who have ever received biologic immunomodulating agents except for those targeting TNFa (investigational or approved). -Previous treatment with any cell-depleting therapies including but not limited to anti- CD20, investigational agents -Other protocol-defined exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.; 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 ;Primary end point(s): American College of Rheumatology 20 (ACR20) response;Timepoint(s) of evaluation of this end point: 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Argentina, Austria, Canada, Chile, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Guatemala, Hungary, India, Ireland, Israel, Italy, Latvia, Lithuania, Mexico, Netherlands, Philippines, Russian Federation, Spain, Sweden, Thailand, United Kingdom, United States, Vietnam
Contacts
Public ContactDrug Regulatory Affairs
Novartis Pharma GmbH
Outcome results
None listed