Psoriatic arthritis MedDRA version: 19.1 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859
Conditions
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 Baseline =3 tender joints out of 78 and =3 swollen out of 76 (dactylitis of a digit counts as one joint each) • Rheumatoid factor and anti-CCP antibodies negative at screening • Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or 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 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. 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 320 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: • Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician • Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine) • 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. The following wash out periods need to be observed: • Oral or topical retinoids 4 weeks • Photochemotherapy (e.g. PUVA) 4 weeks • Phototherapy (UVA or UVB) 2 weeks • Topical skin treatments (except in face, scalp and genital area during screening, only corticosteroids with mild to moderate potency) 2 weeks • 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 (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that the efficacy of secukinumab 75 or 150 or 300 mg at Week 24 is superior to placebo in subjects with active PsA based on the proportion of patients achieving an American College of Rheumatology 20 response (ACR20 response) ;Secondary Objective: -The efficacy of secukinumab 75 or 150 or 300mg at W24 is superior to placebo based on the: •proportion of subjects achieving a PASI75 response in the subgroup of subjects who have =3% skin involvement with psoriasis •proportion of subjects achieving a PASI90 response in the subgroup of subjects who have =3% skin involvement with psoriasis -The improvement from baseline on secukinumab 75 or 150 or 300mg is superior to placebo for the •DAS28-CRP at W24 •SF36-PCS at W24 •HAQ-DI at W24 - The efficacy of secukinumab 75 or 150 or 300mg at W24 is superior to placebo based on the proportion of subjects achieving an ACR50 response - The efficacy of secukinumab pooled regimen (75,150 and 300mg) at W24 is superior to placebo based on the •proportion of subjects with dactylitis in the subset of subjects who have dactylitis at baseline •proportion of subjects with enthesitis in the subset of subjects who have enthesitis at baseline -The overall safety and tolerability ;Primary end point(s): Proportion of subjects achieving American College of Rheumatology 20 response at Week 24 ;Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Proportion of subjects achieving a PASI75 response in the subgroup of subjects who have =3% skin involvement with psoriasis - Proportion of subjects achieving a PASI90 response in the subgroup of subjects who have =3% skin involvement with psoriasis - Change from baseline in DAS28-CRP - Change from baseline in SF36-PCS- Change from baseline in HAQ-DI - Proportion of subjects achieving ACR50 response criteria - Proportion of subjects with dactylitis in the subset of subjects who have dactylitis at baseline - Proportion of subjects with enthesitis in the subset of subjects who have enthesitis at baseline ;Timepoint(s) of evaluation of this end point: Week 24 | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Czech Republic, Germany, Philippines, Poland, Russian Federation, Thailand, United Kingdom, United States
Contacts
Public ContactMedical Information Services
Novartis Pharmaceuticals UK Limited
Outcome results
None listed