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 optimal phase of either 150 mg or 300 mg randomized dose escalation for up to another 2 years

Phase 3

Completed

Conditions: non-radiographic spondyloartritis
10023213

Registration Number: NL-OMON47618

Lead Sponsor: ovartis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

• Male or non-pregnant, non-nursing female patients at least 18 years of age
• Diagnosis of axSpA according to ASAS axSpA criteria
• Objective signs of inflammation (MRI or abnormal CRP)
• Active axSpA as assessed by total BASDAI >=4 cm
• Spinal pain as measured by BASDAI question #2 >= 4 cm (0-10 cm) at baseline
• Total back pain as measured by VAS >= 40 mm (0-100 mm) at baseline
• Patients should have been on at least 2 different NSAIDs with an inadequate
response
• Patients who have been on a TNFa inhibitor (not more than one) must have
experienced an inadequate response
For the extension phase of the study:
• Patients who have completed the full study treatment period (104 weeks) in
the core phase on study treatment.
• Other protocol-defined inclusion criteria may apply

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 IL-17 or IL-17 receptor
• Pregnant or nursing (lactating) women
• Other protocol-defined exclusion criteria may apply

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The proportion of TNF-naive patients achieving an ASAS 40 response</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- The proportion of all patients achieving an ASAS40 response<br /><br>- The proportion of TNF naïve patients achieving an ASAS40 response<br /><br>- The proportion of patients meeting the ASAS 5/6 response criteria<br /><br>- Change in BASDAI over time<br /><br>- The proportion of patients achieving a BASDAI 50 response<br /><br>- Change in hsCRP over time<br /><br>- Change in BASFI over time<br /><br>- Change in SI Joint Edema<br /><br>- The proportion of patients achieving an ASAS20 response<br /><br>- Change in SF-36 physical Component Summary over time<br /><br>- Change in ASQoL over time<br /><br>- The proportion of patients achieving an ASAS partial remission<br /><br>- Safety and Tolerability</p><br>