Phase 3
Completed N=371
16 Week Efficacy and 2 Year Long Term Safety and Efficacy of Secukinumab in Patients With Active Ankylosing Spondylitis
Source: ClinicalTrials.gov NCT01358175 ↗Enrolled (actual)
371
Serious AEs
10.6%
Results posted
Jan 2017
Primary outcomePrimary: Assessment of Responders for the SpondyloArthritis International Society / ASAS 20 Response — 59.7; 60.8; 28.7 % responders — p=<0.0001
◆ Published Evidence
Established
22citations · ~4 / year
Effects of secukinumab on bone mineral density and bone turnover biomarkers in patients with ankylosing spondylitis: 2-year data from a phase 3 study, MEASURE 1.
Summary
This study will assess the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy.
Linked Publications (5)
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Effects of secukinumab on bone mineral density and bone turnover biomarkers in patients with ankylosing spondylitis: 2-year data from a phase 3 study, MEASURE 1.
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A Pooled Analysis Reporting the Efficacy and Safety of Secukinumab in Male and Female Patients with Ankylosing Spondylitis.
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Secukinumab Efficacy on Enthesitis in Patients With Ankylosing Spondylitis: Pooled Analysis of Four Pivotal Phase III Studies.
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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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Automated detection of spinal bone marrow oedema in axial spondyloarthritis: training and validation using two large phase 3 trial datasets.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of Responders for the SpondyloArthritis International Society / ASAS 20 Response |
59.7; 60.8; 28.7 | <0.0001 sig |
| SECONDARY Assessment of Responders for the SpondyloArthritis International Society ASAS 40 Response |
33.1; 41.6; 13.1 | — |
| SECONDARY Change From Baseline in Serum hsCRP |
0.45; 0.4; 0.97 | — |
| SECONDARY Assessment of Responders for the SpondyloArthritis International Society ASAS 5/6 Response |
45.2; 48.8; 13.1 | — |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index / BASDAI |
-2.34; -2.32; -0.59 | — |
| SECONDARY Change From Baseline in Physical Function Component of the Short-form Health Survey / SF-36 PCS |
5.64; 5.57; 0.96 | — |
| SECONDARY Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire / ASQoL |
-3.61; -3.58; -1.04 | — |
| SECONDARY Assessment of Responders for ASAS Partial Remission |
16.1; 15.2; 3.3 | — |
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 (1984)
- 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
- Patients who have been on an anti-TNFα agent (not more than one) must have experienced an inadequate response
Exclusion criteria
- Chest X-ray 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
- Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01358175) 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.