A randomized, double-blind, placebo-controlled multicenter study of secukinumab 150 mg in patients with active non-radiographic axial spondyloarthritis to evaluate the safety, tolerability and efficacy up to 2 years, followed by an optional phase of either 150 mg or 300 mg randomized dose escalation for up to another 2 years
Study of Efficacy and Safety of Secukinumab in Patients With Non-radiographic Axial Spondyloarthritis
Nov. 03, 2021
No
version:
date:
Novartis Pharma K. K.
+81-120-003-293
Novartis Pharma K. K.
+81-120-003-293
completed
April. 29, 2016
24
Interventional
Randomized, Parallel Assignment, Double Blind Study
treatment purpose
3
*Male or non-pregnant, non-nursing female patients at least 18 years of age
*Diagnosis of axial spondyloarthritis according to Ankylosing SpondyloArthritis International Society (ASAS) axial spondyloarthritis criteria
*objective signs of inflammation (magnetic resonance imaging (MRI) or abnormal C-reactive protein)
*active axial spondyloarthritis as assessed by total Bath Ankylosing Spondylitis Disease Activity Index >=4 cm
*Spinal pain as measured by Bath Ankylosing Spondylitis Disease Activity Index question #2 >= 4 cm (0-10 cm) at baseline
*Total back pain as measured by Visual Analogue scale >= 40 mm (0-100 mm) at baseline
*Patients should have been on at least 2 different non-steroidal anti-inflammatory drugs with an inadequate response
*Patients who have been on a TNFalfa inhibitor (not more than one) must have experienced an inadequate response
*Patients with radiographic evidence for sacroiliitis, grade >= 2 bilaterally or grade >= 3 unilaterally
*Inability or unwillingness to undergo MRI
*Chest X-ray or MRI with evidence of ongoing infectious or malignant process
*Patients taking high potency opioid analgesics
*Previous exposure to secukinumab or any other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor
*Pregnant or nursing (lactating) women
Other protocol-defined inclusion/exclusion criteria may apply.
18age old over
No limit
Both
Non-radiographic Spondyloarthritis
investigational material(s)
Generic name etc : Secukinumab
INN of investigational material : Cosentyx
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigational material : Induction: 4x 150 mg Secukinumab s.c. weekly, Maintenance: 150 mg Secukinumab s.c. monthly. Dose escalation to 300mg at Year 2 (Secukinumab 150mg s.c. no load: 150mg Secukinumab s.c. monthly)
control material(s)
Generic name etc : Placebo
INN of investigational material : Placebo
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Induction: 4x placebo s.c. weekly, Maintenance: placebo s.c. monthly
efficacy
The proportion of participants who achieved an ASAS 40 response (Assessment of SpondyloArthritis International Society criteria) [ Time Frame: Week 16, 52 ]
ASAS40 (Assessment of SpondyloArthritis International Society criteria) response is defined as an improvement of >=40% and >=2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain
efficacy
The proportion of participants who achieved an ASAS 5/6 [ Time Frame: Week 16 ]
The ASAS 5/6 improvement criteria is an improvement of >=20% in at least five of all six domains
efficacy
Change in BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) over time [ Time Frame: Week 16 ]
The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) consists of a 0 through 10 scale (0 being no problem and 10 being the worst problem, captured as a continuous VAS), which is used to answer 6 questions pertaining to the 5 major symptoms of AS
safety
Change in SF-36 (Short Form-36 Physical Component Summary) physical Component Summary over time [ Time Frame: Week 16 and 52 ]
The SF-36 (Short Form-36 Physical Component Summary) is an instrument to measure health-related quality of life among healthy patients and patients with acute and chronic conditions
