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Efficacy and Safety Study of Secukinumab in Chinese Participants With Non-radiographic Axial Spondyloarthritis

CompletedPhase 3

Sponsor: Novartis Pharmaceuticals

Conditions: Non-radiographic Axial Spondyloarthritis

Interventions: Secukinumab, Placebo

Countries: China

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (29)

Hefei, Anhui, China
Hefei, Anhui, China
Beijing, Beijing Municipality, China
Xiamen, Fujian, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Shantou, Guangdong, China
Shenzhen, Guangdong, China
Harbin, Heilongjiang, China
Wuhan, Hubei, China
Changsha, Hunan, China
Baotou, Inner Mongolia, China
Nanjing, Jiangsu, China
Nanjing, Jiangsu, China
Yangzhou, Jiangsu, China
Nanchang, Jiangxi, China
Pingxiang, Jiangxi, China
Changchun, Jilin, China
Linyi, Shandong, China
Ürümqi, Xinjiang, China
Kunming, Yunnan, China
Ningbo, Zhejiang, China
Wenzhou, Zhejiang, China
Beijing, China
Beijing, China
Bengbu, China
Shanghai, China
Shanghai, China
Tianjin, China