Phase 3
N=219
16 Week Efficacy and 5 Year Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis
Anklyosing Spondylitis
Bottom Line
View on ClinicalTrials.gov: NCT01649375 ↗Enrolled (actual)
219
Serious AEs
18.0%
Results posted
Oct 2019
Primary outcome: Primary: Percentage of Participants Achieving ASAS 20 (SpondyloArthritis International Society Criteria) Response at Week 16 — 41.1; 61.1; 28.4 percentage of participants — p=0.0967
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Secukinumab (75 mg) (Drug); Placebo (Drug); Secukinumab (150 mg) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving ASAS 20 (SpondyloArthritis International Society Criteria) Response at Week 16 |
41.1; 61.1; 28.4 | 0.0967 |
| SECONDARY Percentage of Participants Achieving ASAS 40 (SpondyloArthritis International Society Criteria) Response |
26.0; 36.1; 10.8 | 0.0194 sig |
| SECONDARY Change From Baseline at Week 16 in Serum hsCRP |
0.61; 0.55; 1.13 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving ASAS 5/6 (SpondyloArthritis International Society Criteria) Response at Week 16 |
34.2; 43.1; 8.1 | 0.0003 sig |
| SECONDARY Change From Baseline at Week 16 for Total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) |
-1.92; -2.19; -0.85 | <0.0001 sig |
| SECONDARY Change From Baseline at Week 16 in Physical Function Component Summary (PCS) of the Medical Outcomes Study Questionnaire Short-form Health Survey (SF-36) |
4.77; 6.06; 1.92 | 0.0110 sig |
| SECONDARY Change From Baseline at Week 16 in ASQoL |
-3.33; -4.00; -1.37 | 0.0096 sig |
| SECONDARY Percentage of Participants Achieving ASAS Partial Remission at Week 16 |
15.1; 13.9; 4.1 | 0.0325 sig |
Summary
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01649375). 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.