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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01863732 |
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Date of registration:
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23/05/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Extension in AS: Sustainability of Benefits, Safety and Tolerability
MEASURE 1 ext |
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Scientific title:
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An Extension Study to Evaluate the Sustainability of Clinical Benefits, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis |
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Date of first enrolment:
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November 6, 2013 |
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Target sample size:
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274 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01863732 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Belgium
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Bulgaria
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Canada
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France
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Germany
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Italy
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Mexico
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Netherlands
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Peru
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Russian Federation
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Taiwan
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Turkey
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United Kingdom
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United States
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Contacts
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Spondylitis, Ankylosing
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Intervention(s)
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Other: Placebo (Pbo)
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Biological: Secukinumab
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Primary Outcome(s)
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Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260
[Time Frame: Week 104 to Week 260]
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Secondary Outcome(s)
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Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260
[Time Frame: Week 104 to Week 260]
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Secondary ID(s)
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2013-001089-40
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CAIN457F2305E1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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