Psoriatic arthritis Axial spondyloarthritis MedDRA version: 19.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 19.0 Level: PT Classification code 10071400 Term: Axial spondyloarthritis System Organ Class: 10
Conditions
Sponsors
Novartis Farmacéutica, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Psoriatic arthritis patients must fulfill the following criteria: Diagnosis of Psoriatic arthritis classified by Classification criteria for Psoriatic Arthritis (CASPAR criteria) with symptoms for at least 6 months and active Psoriatic arthritis as assessed by > 1 tender joints out of 78 and > 1 swollen joints out of 76 at Baseline (dactylitis of a digit counts as one joint each) - Axial Spondyloarthritis patients must fulfill the following criteria: Axial Spondyloarthritis as per the classification of the Assessment of Spondyloarthritis International Society axial Spondyloarthritis (ASAS) criteria with objective signs of inflammation at Screening (magnetic resonance imaging (MRI) with Sacroiliac joint inflammation or definite radiographic sacroilitis according to the modified New York (NY) criteria and/or abnormal high sensitivity C-Reactive Protein (hsCRP)) and active disease assessed by total Bath ankylosing spondylitis disease activity index (BASDAI) = 4 (0–10) at Baseline - Diagnosis of Achilles tendon enthesitis according to swelling and tenderness at the insertional site of the Achilles tendon into the calcaneus - Onset of heel pain = 1 month up to 5 years at Baseline - Heel enthesitis that is magnetic resonance imaging (MRI)-positive according to the investigator`s judgement - Patients who are Tumor necrosis factor (TNF) inhibitor-naive 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 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process - Previous exposure to secukinumab or other biologic drug directly targeting Interleukin (IL)-17 or Interleukin (IL)-17 receptor - Ongoing use of psoriasis treatments / medications (e.g. topical corticosteroids, ultraviolet (UV) therapy) at randomization - Patients who have previously been treated with Tumor necrosis factor (TNF) inhibitors (investigational or approved). - Patients who have ever received biologic immunomodulating agents (investigational or approved) - Pregnant or nursing (lactating) women - History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection Other protocol defined exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that the efficacy of secukinumab is superior to placebo based on the percentage of patients with resolution of Achilles tendon enthesitis as assessed by the respective subcomponent of the Leeds enthesitis index (LEI) at Week 24 in patients with active PsA and axSpA.; Secondary Objective: To demonstrate the efficacy of secukinumab at Week 24 is superior to placebo based on: -mean change of heel pain measured on a 10-point NRS -percentage of patients with an improvement of bone marrow edema as assessed by the respective subcomponent of the PsAMRIS in the affected foot at BSL -percentage of patients with resolution of enthesitis as assessed by the LEI -mean change in physician's and patient`s global assessment of disease activity -mean change in physician's and patient`s global assessment of heel enthesiopathy activity -change from BSL in SF-36 PCS or SF-36v2 To describe (after switching from placebo to secukinumab at Week 24) the increase in: -percentage of patients with resolution of Achilles tendon enthesitis -mean change of heel pain in patients Overall safety and tolerability of secukinumab ;Primary end point(s): Percentage of patients with resolution of Achilles tendon enthesitis;Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Heel pain 2) Percentage of patients with an improvement of bone marrow edema 3) Percentage of patients with resolution of enthesitis 4) Physician`s global assessment of disease activity 5) Patient`s global assessment of disease activity 6) Physician`s global assessment of heel enthesiopathy activity 7) Patient`s global assessment of heel enthesiopathy activity 8) Short Form-36 Physical Component Summary (SF-36 PCS) or Short Form-36 (SF-36) v2 9) Percentage of patients with resolution of Achilles tendon enthesitis after switching from placebo 10) Heel pain in patients after switching from placebo 11) Safety and tolerability ; Timepoint(s) of evaluation of this end point: 1-8: Week 24 9 + 10: Week 52 11: BSL - Week 52 | — |
Countries
Bulgaria, Czech Republic, Germany, Greece, Slovakia, Spain, United Kingdom
Contacts
Public ContactDepartamento Médico (LCO)
Novartis Farmacéutica
Outcome results
None listed