Phase 3
Completed N=414
24 Week Efficacy and 3-year Safety and Efficacy of Secukinumab in Active Psoriatic Arthritis
Source: ClinicalTrials.gov NCT01989468 ↗Enrolled (actual)
414
Serious AEs
15.7%
Results posted
Apr 2019
Primary outcomePrimary: Proportion of Patients Achieving American College of Rheumatology 20 (ACR20) Response Criteria on Secukinumab Versus Placebo at Week 24 — 58; 67; 22 Participants
◆ Published Evidence
Highly cited
167citations · ~21 / year
Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3).
Summary
The purpose of this study is to provide 24 - 52 week efficacy, safety and tolerability data, and up to 3-year efficacy, safety and tolerability data in subjects with active Psoriatic Arthritis despite current or previous nonsteroidal anti-inflammatory drug (NSAID), disease-modifying antirheumatic drug (DMARD) therapy and/or previous anti-tumor necrosis factor alpha (TNFα) therapy.
Linked Publications (5)
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Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3).
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Secukinumab Immunogenicity over 52 Weeks in Patients with Psoriatic Arthritis and Ankylosing Spondylitis.
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Clinically relevant patient clusters identified by machine learning from the clinical development programme of secukinumab in psoriatic arthritis.
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Secukinumab efficacy on resolution of enthesitis in psoriatic arthritis: pooled analysis of two phase 3 studies.
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Comparative Effectiveness of Bimekizumab and Secukinumab in Patients with Psoriatic Arthritis at 52 Weeks Using a Matching-Adjusted Indirect Comparison.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Achieving American College of Rheumatology 20 (ACR20) Response Criteria on Secukinumab Versus Placebo at Week 24 |
58; 67; 22 | — |
| SECONDARY Proportion of Patients Achieving American College of Rheumatology 50 (ACR50) Response Criteria on Secukinumab Versus Placebo at Week 24 |
26; 48; 12 | — |
| SECONDARY Change From Baseline in Disease Activity Score for 28 Joints (DAS28-CRP) (Utilizing hsCRP) in Subjects Treated With Secukinumab Versus Placebo at Week 24 |
-1.24; -1.56; -0.64 | — |
| SECONDARY Proportion of Subjects Achieving a Psoriatic Area and Severity Index 75 (PASI75) Response in Subjects on Secukinumab Versus Placebo at Week 24 |
34; 29; 6 | — |
| SECONDARY Change From Baseline in Physical Function Component of the Short-form Health Survey (SF-36-PCS) in Subjects Treated With Secukinumab Versus Placebo at Week 24 |
1.68; 4.41; -0.10; 3.42; 6.46; 2.94 | — |
| SECONDARY Percentage of Subjects Achieving a Psoriatic Area and Severity Index 90 (PASI90) Response in Subjects Treated With Secukinumab Versus Placebo at Week 24 |
25; 21; 4 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI Score) in Subjects Treated With Secukinumab Versus Placebo at Week 24 |
-0.27; -0.38; -0.17 | — |
| SECONDARY Proportion of Patients With Dactylitis at Week 24 in the Subset of Patients Who Had Dactylitis at Baseline |
22; 24; 31 | — |
| SECONDARY Proportion of Patients With Enthesitis at Week 24 in the Subset of Patients Who Had Enthesitis at Baseline |
60; 53; 83 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by Primary System Organ Class (SOC) |
176; 230; 363; 81; 42; 35 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Psoriatic Arthritis (PsA) classified by ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria.
- Rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative.
- Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis.
- Inadequate control of symptoms with NSAID.
Exclusion Criteria
- Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process.
- Subjects taking high potency opioid analgesics.
- Previous exposure to secukinumab or other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor.
- Ongoing use of prohibited psoriasis treatments / medications.
- Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα.
- Previous treatment with any cell-depleting therapies.
Data sourced from ClinicalTrials.gov (NCT01989468) 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.