Efficacy and Safety Study of Secukinumab in Chinese Participants With Non-radiographic Axial Spon… (NCT04732117) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety Study of Secukinumab in Chinese Participants With Non-radiographic Axial Spondyloarthritis
China137 participantsStarted 2021-07-21
Plain-language summary
The purpose of this study was to evaluate the efficacy, safety, and tolerability of secukinumab in Chinese patients with active non-radiographic axial spondyloarthritis (nr-axSpA).
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion Criteria:
* 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 TNFα inhibitor (not more than one) must have experienced an inadequate response
Exclusion Criteria:
* 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.
What they're measuring
1
Assessment of SpondyloArthritis International Society 40 (ASAS40) Response Rate in TNF-alpha-inhibitor-naive Participants at Week 16