Peripheral Spondyloarthritis MedDRA version: 20.0 Level: HLT Classification code 10052775 Term: Spondyloarthropathies 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 or Proposed INN: Secukinumab
CAS Number: 1229022-83-6
Current S
Sponsors
NOVARTIS PHARMA AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participant meets ASAS criteria for classification of pSpA: · Participant must have current arthritis (asymmetric or predominantly in the lower limbs) or enthesitis (except for enthesitis only along the spine, sacroiliac joints and/or chest wall) or dactylitis. AND at least one of the following SpA features: · Anterior uveitis in the past confirmed by a qualified medical professional (participants with current ongoing uveitis are excluded from participation in the study). · Evidence of preceding infection (acute diarrhea or non-gonococcal urethritis or cervicitis less than 1 month before arthritis). · Human Leukocyte Antigen -B27 (HLA-B27) positivity. · Sacroiliitis on imaging; based on prior magnetic resonance imaging (MRI) or X-ray. OR at least 2 of the following SpA features: · Arthritis (past or present diagnosis), adequately documented and identified, or diagnosed by a qualified medical professional. · Enthesitis (any location, past or present diagnosis), adequately documented and identified, or diagnosed by a qualified medical professional. · Dactylitis (past or present diagnosis) adequately documented and identified, or diagnosed by a qualified medical professional. · Inflammatory back pain (past or present). · Family history for SpA. Diagnosis of pSpA with evidence of active disease as manifested by · Patient's global assessment of disease activity (0-100 VAS) >= 40 mm, and · Patient's global assessment of pain (0-100 VAS) >= 40 mm, and · At least one of the following: · >= 2 joints that are both tender and swollen · >= 2 sites of severe enthesitis as assessed by the investigator and >= 1 joint that is both tender and swollen · >= 2 digits with dactylitis and >=1 joint that is both tender and swollen not associated with dactylitis Participant should have been on at least 2 different non-steroidal antiinflammatory drugs (NSAIDs) at the highest recommended dose for at least 4 weeks in total prior to randomization with an inadequate response or failure to respond, or less if therapy had to be withdrawn due to intolerance, toxicity or contraindications. Participant taking methotrexate (=65 years) yes F.1.3.1 Number of subjects for this age range 32
Exclusion criteria
Exclusion criteria: Current or previous diagnosis of any of the following: · Psoriasis (PsO) and/or nail changes consistent with PsO diagnosed by a qualified medical professional. · PsA diagnosed by a qualified medical professional. · Inflammatory bowel disease (IBD) diagnosed by a qualified medical professional. · axSpA by a qualified medical professional. Meets ASAS Axial Spondyloarthritis (axSpA) criteria. Score of >=2 on numerical rating scale (NRS)-score for total back pain and nocturnal back pain. (score 0–10). History of a confirmed diagnosis of any inflammatory joint disorder other than pSpA (e.g., rheumatoid arthritis, gouty arthritis, other crystalline arthritis, systemic lupus erythematosus, or any arthritis with onset prior to age 16 years such as juvenile idiopathic arthritis). Prior exposure to Tumor Necrosis Factor inhibitors (TNF-i's) or other biologics, immunomodulating agents, investigational or approved. Active ongoing inflammatory diseases other than pSpA that might confound the evaluation of the benefit of secukinumab therapy (e.g., uveitis).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective and clinical question of interest of this study is to demonstrate the superiority of secukinumab compared to placebo based on Modified Peripheral SpondyloArthritis Response Criteria 40 (mPSpARC40) response at Week 16 in participants with active pSpA;Secondary Objective: To demonstrate the superiority of secukinumab compared to placebo based on: -Analysis Plan A (At Week 16): In participants with undifferentiated pSpA: mPSpARC40 response In participants with active pSpA: mPSpARC50 response, ACR 50 response, physician's global assessment of disease activity, SF-36 PCS, HAQ-DI, enthesitis count for enthesitis subset ; patient global assessment of disease activity & pain -Analysis Plan B (Week 16 and Week 52): In participants with undifferentiated pSpA: mPSpARC40 response at week 16 & 52 In participants with active pSpA: At week 52: mPSpARC40 response At week 16 & 52: ACR 50 response At week 16: mPSpARC50 response ; physician's global assessment of disease activity, SF-36 PCS, HAQ-DI, enthesitis count for enthesitis subset, patient global assessment of disease activity & pain. The overall safety and tolerability of secukinumab compared to placebo as assessed by AEs, vital signs, clinical laboratory values, and adverse events monitoring.;Primary end point(s): Proportion of participants with active pSpA who achieve a mPSpARC40 response at Week 16 defined as meeting the following: - >= 40% improvement as well as a >= 20 mm absolute improvement from baseline in the VAS scores for patient's global assessment of disease activity and patient's global assessment of pain AND - >= 40% improvement in at least one of the following domains and no concurrent worsening in the other domains: 1. SJC (76 joints assessed) and TJC (78 joints assessed) or 2. Enthesitis count as measured by the SPARCC Enthesitis Index 3. Dactylitis count as measured by LDI;Timepoint(s) of evaluation of this end point: 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Objectives associated with Analysis Plan A (Week 16) -Proportion of participants with undifferentiated pSpA achieving mPSpARC>=40 response at Week 16 -Proportion of participants with active pSpA achieving mPSpARC>=50 at Week 16 -Proportion of participants with active pSpA achieving ACR 50 at Week 16 -Change in physician's global assessment of disease activity (0-100 mm VAS) from -Baseline to Week 16 in participants with active pSpA -Change in SF-36 PCS from Baseline to Week 16 in participants with active pSpA -Change in HAQ-DI improvement (change) from Baseline to Week 16 in participants with active pSpA -Change in enthesitis count from Baseline to Week 16 utilizing the SPARCC enthesitis index in participants with active pSpA. -Change in patient's global assessment of pain (0- 100 mm VAS) from Baseline to Week 16 in participants with active pSpA -Change in patient's global assessment of disease activity (0-100 mm VAS) from Baseline to Week 16 in participants with active pSpA -Assessment of Treatment Emergent Adverse Events (TEAEs) and changes in physical exams, Electrocardiogram (ECG)s, vital signs, laboratory assessments. Objectives associated with Analysis Plan B (Week 16 and Week 52) -Proportion of participants with active pSpA achieving mPSpARC>40 response at Week 52 -Proportion of participants with active undifferentiated pSpA achieving mPSpARC>=40 response at Week 16 -Proportion of participants with active undifferentiated pSpA achieving mPSpARC>=40 response at Week 52 -Proportion of participants with active pSpA achieving mPSpARC>=50 at Week 16 -Proportion of participants with active pSpA achieving ACR 50 at Week 16 -Proportion of participants with active pSpA achieving ACR 50 at Week 52 -Change in physician's global assessment of disease activity (0-100 mm VAS) from Baseline to Week 16 in participants with active pSpA -Change in SF-36 PCS from Baseline to Week 16 in participants with active pSpA -Change in HAQ-DI from Baseline to Week | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, China, Colombia, Czechia, Estonia, Germany, Guatemala, Hungary, India, Italy, Philippines, Poland, Russian Federation, Slovakia, South Africa, Spain, Thailand, Turkey, United States, Vietnam
Contacts
Public ContactRegulatory Affairs
Novartis Farma S.p.A.
Outcome results
None listed