Phase 3
Completed N=274
Extension in AS: Sustainability of Benefits, Safety and Tolerability
Spondylitis, Ankylosing
Source: ClinicalTrials.gov NCT01863732 ↗
Enrolled (actual)
274
Serious AEs
13.1%
Results posted
Jul 2019
Primary outcomePrimary: Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 — 71.4; 80.0; 78.6; 73.0 % of responders
◆ Published Evidence
Highly cited
142citations · ~20 / year
Secukinumab shows sustained efficacy and low structural progression in ankylosing spondylitis: 4-year results from the MEASURE 1 study.
Summary
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.
Linked Publications (5)
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Secukinumab shows sustained efficacy and low structural progression in ankylosing spondylitis: 4-year results from the MEASURE 1 study.
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Long-term efficacy and safety of secukinumab 150 mg in ankylosing spondylitis: 5-year results from the phase III MEASURE 1 extension study.
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Achievement of Remission Endpoints with Secukinumab Over 3 Years in Active Ankylosing Spondylitis: Pooled Analysis of Two Phase 3 Studies.
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Secukinumab and Sustained Reduction in Fatigue in Patients With Ankylosing Spondylitis: Long-Term Results of Two Phase III Randomized Controlled Trials.
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Secukinumab Demonstrates Sustained Efficacy and Safety in a Taiwanese Subpopulation With Active Ankylosing Spondylitis: Four-Year Results From a Phase 3 Study, MEASURE 1.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 |
71.4; 80.0; 78.6; 73.0; 76.0; 82.1 | — |
| SECONDARY Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 |
53.6; 65.0; 57.1; 48.6; 56.3; 59.5 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01863732) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.