Study of Efficacy and Safety of Secukinumab in Patients With Non-radiographic Axial Spondyloarthritis
- Conditions
- on-radiographic Spondyloarthritis
- Registration Number
- JPRN-jRCT2080223230
- Lead Sponsor
- ovartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 24
*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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>The proportion of participants who achieved an ASAS 40 response (Assessment of SpondyloArthritis International Society criteria) [ Time Frame: Week 16, 52 ]<br>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
- Secondary Outcome Measures
Name Time Method efficacy<br>The proportion of participants who achieved an ASAS 5/6 [ Time Frame: Week 16 ]<br>The ASAS 5/6 improvement criteria is an improvement of >=20% in at least five of all six domains<br>efficacy<br>Change in BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) over time [ Time Frame: Week 16 ]<br>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<br>safety<br>Change in SF-36 (Short Form-36 Physical Component Summary) physical Component Summary over time [ Time Frame: Week 16 and 52 ] <br>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