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: Secukinumab
Product Code: AIN457
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Secukinumab
CAS Number: 1229022-83-6
Current
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient must be able to understand and communicate with the Investigator and comply with the requirements of the study and must provide written, signed and dated informed consent before any study assessment is performed. - Male or female patients at least 18 years of age. - Diagnosis of PsA as per CASPAR with active PsA for at least 6 months and a TJC = 3 of 78 and SJC = 3 of 76 at Baseline. - Patients must have a total synovitis PDUS score = 2 and inflammation related to PD signal = 1 for at least 2(affected joints as observed via PDUS) of 48 joints at the Screening visit and at the Baseline visit (before infusion). - At least 1 clinically-involved enthesitis site at Screening and at the Baseline visit (before infusion) defined by SPARCC index different from 0. 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 145 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 19
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. -Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor. -Any change in the dose of oral corticosteroids in the last 4 weeks prior to the Baseline visit or use of i.v. intramuscular or intra-articular corticosteroid during the last 4 weeks prior to the enrollment visit. -Patients who have previously been treated with TNFa inhibitors (investigational or approved). -History of hypersensitivity to the study drug or its excipients or to drugs of similar classes. -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). -Prohibited psoriasis treatments/medications with topical corticosteroids in the last 4 weeks prior to randomization. -Pregnant or nursing (lactating) women. Other protocol defined exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that there is a difference between secukinumab and placebo in terms of joint synovitis response over 12 weeks as measured by the PDUS Global OMERACT-EULAR Synovitis Score (GLOESS) of the affected joints (out of 48 joints) in PsA patients with an inadequate response (IR) to non biologic DMARDs.;Secondary Objective: Key secondary objectives: •To demonstrate that the efficacy of secukinumab at Week 12 is superior to placebo based on the proportion of patients achieving: - an ACR 20 response - an ACR 50 response •To demonstrate that the clinical response of secukinumab at Week 12 is superior to placebo based on the change in SPARCC enthesitis index from Baseline to Week 12. ;Primary end point(s): Difference between secukinumab and placebo in terms of joint synovitis;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - American College of Rheumatology (ACR)-20 - ACR-50 - Spondyloarthritis Research Consortium of Canada(SPARCC) ;Timepoint(s) of evaluation of this end point: Baseline to Week 12 | — |
Countries
Argentina, Austria, Belgium, Canada, Colombia, Czech Republic, France, Germany, Hungary, Ireland, Italy, Mexico, Netherlands, Norway, Spain, United Kingdom, United States
Contacts
Public ContactMedica Information Services
Novartis Pharmaceuticals UK Limited
Outcome results
None listed