NL-OMON43926
Completed
Phase 3
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) - CAIN457F2310
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- ankylosing spondylitis
- Sponsor
- ovartis
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* 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.
Exclusion Criteria
- •\* 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
Outcomes
Primary Outcomes
Not specified
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