A randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis
Phase 3
Completed
- Conditions
- Bechterew disease10023213
- Registration Number
- NL-OMON44029
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
Inclusion Criteria
- Moderate to severe AS
- Prior radiographic evidence according to the Modified NY Criteria (1984)
- Inadequate response to NSAIDs;See protocol for other inclusion criteria.
Exclusion Criteria
- Pregnancy or lactation
- On-going infectious or malignant process on a chest X-ray or MRI
- Previous exposure to IL-17 or IL-17R targeting therapies
- Previous exposure to any biological immunomodulating agent excluding TNF antagonists
- Previous cell depleting therapy;See protocol for other exclusion criteria.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>ASAS20</p><br>
- Secondary Outcome Measures
Name Time Method <p>ASAS20, ASAS40, adverse events.</p><br>