A randomized, double-blind, placebo-controlled phase III multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 16 weeks and to assess the long-term efficacy, safety and tolerability up to 5 years in patients with active Ankylosing Spondylitis (CAIN457F2310)
- Conditions
- ankylosing spondylitis10023213
- Registration Number
- NL-OMON43926
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
* Male or non-pregnant, non-lactating female patients at least 18 years of age.
* Diagnosis of moderate to severe AS with prior documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS.
* Patients should have been on NSAIDs with an inadequate response.
* Patients who are regularly taking NSAIDs as part of their AS therapy are required to be on a stable dose for at least 2 weeks.
* Patients who have been on an anti-TNF* agent (not more than one) must have experienced an inadequate response.
* Chest X-ray with evidence of ongoing infectious or malignant process.
* Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or IL-17-receptor.
* Patients previously treated with any biological immunomodulating agents except for those targeting TNF*
* Previous treatment with any cell-depleting therapies
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>