16 Week Efficacy and 5 Year Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis
CompletedPhase 3NCT01649375
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Brief summary (from the registry)
This study assessed the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who were tolerant to or had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor
Study details
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase III Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Efficacy at 16 Weeks and to Assess Long-term Efficacy, Safety and Tolerability up to 5 Years in Patients With Active Ankylosing Spondylitis
- Conditions
- Anklyosing Spondylitis
- Interventions
- Drug: Secukinumab (75 mg)
- Drug: Placebo
- Drug: Secukinumab (150 mg)
- Sponsor
- Novartis Pharmaceuticals
- Organization
- Novartis
- Start date
- 2012-10-18
- Primary completion
- 2014-08-04
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Austria, Canada, Czechia, Finland, Germany, Italy, Netherlands, Russia, Singapore, Spain, Switzerland, United Kingdom, United States
- Total sites listed
- 53
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Male or non-pregnant, non-lactating female patients * Diagnosis of moderate to severe AS with prior documented radiologic evidence (x-ray) fulfilling the Modified New York criteria for AS (1984) * Patients should have been on NSAIDs with an inadequate response * Patients who were regularly taking NSAIDs as part of their AS therapy are required to be on a stable dose * Patients who had been on an anti-TNFα agent (not more than one) must have experienced an inadequate response Exclusion Criteria: * Chest X-ray (or MRI) with evidence of ongoing infectious or malignant process * Patients with total ankylosis of the spine * Patients previously treated with any biological immunomodulating agents except for those targeting TNFα * Previous treatment with any cell-depleting therapies
Canadian sites (4)
| Facility | City | Province |
|---|---|---|
| Novartis Investigative Site | Winnipeg | Manitoba |
| Novartis Investigative Site | Pointe-Claire | Quebec |
| Novartis Investigative Site | Québec | Quebec |
| Novartis Investigative Site | Sainte-Foy | Quebec |
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01649375