Extension in AS: Sustainability of Benefits, Safety and Tolerability
CompletedPhase 3NCT01863732
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Brief summary (from the registry)
This 3-year extension study aims at making available the treatment with secukinumab in prefilled syringes (PFS) to patients with ankylosing spondylitis who took part in phase III study CAIN457F2305, defined as "core study", as well as to generate additional data on the sustainability of clinical benefits, safety and tolerability during long-term administration of secukinumab.
Study details
- Official title
- An Extension Study to Evaluate the Sustainability of Clinical Benefits, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis
- Conditions
- Spondylitis, Ankylosing
- Interventions
- Biological: Secukinumab
- Other: Placebo (Pbo)
- Sponsor
- Novartis Pharmaceuticals
- Organization
- Novartis
- Start date
- 2013-11-06
- Primary completion
- 2018-03-16
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Belgium, Bulgaria, Canada, France, Germany, Italy, Mexico, Netherlands, Peru, Russia, Taiwan, Turkey (Türkiye), United Kingdom, United States
- Total sites listed
- 56
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: patients having completed the "core study" CAIN457F2305, indication for treatment extension. -- Exclusion Criteria: history of hypersensitivity to secukinumab or to any drug of similar chemical classes, use of any investigational drug other than secukinumab during the "core study" CAIN457F2305.
Canadian sites (2)
| Facility | City | Province |
|---|---|---|
| Novartis Investigative Site | Winnipeg | Manitoba |
| Novartis Investigative Site | St. John's | Newfoundland and Labrador |
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01863732