Phase 3
Completed N=86
Secukinumab Safety and Efficacy in Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related Arthritis (ERA)
Source: ClinicalTrials.gov NCT03031782 ↗Enrolled (actual)
86
Serious AEs
12.8%
Results posted
Aug 2022
Primary outcomePrimary: Number of Participants Experiencing a Flare During Treatment Period 2 — 10; 21 Participants — p=<0.001
◆ Published Evidence
Established
77citations · ~26 / year
Secukinumab in enthesitis-related arthritis and juvenile psoriatic arthritis: a randomised, double-blind, placebo-controlled, treatment withdrawal, phase 3 trial.
Summary
This was a double-blind, placebo-controlled, event-driven randomized withdrawal study to investigate the efficacy and safety of secukinumab treatment in the Juvenile Idiopathic Arthritis (JIA) categories of Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related Arthritis (ERA). The study was divided into 3 parts (plus a post-treatment follow-up period) consisting of open-label, single-arm active treatment in Treatment Periods 1 and 3 and a randomized, double-blind, placebo controlled, event-driven withdrawal design in Treatment Period 2
Linked Publications (2)
-
Secukinumab in enthesitis-related arthritis and juvenile psoriatic arthritis: a randomised, double-blind, placebo-controlled, treatment withdrawal, phase 3 trial.
-
Juvenile Spondyloarthritis Disease Activity Index Validation in Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis in a Prospective Clinical Trial Setting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing a Flare During Treatment Period 2 |
10; 21 | <0.001 sig |
| SECONDARY Percent of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90/100 Response at Week 12 - by JIA Category |
86.3; 96.9; 80.4; 96.9; 66.7; 75.0 | — |
| SECONDARY Percent of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90/100 Response at Week 12 - Total |
90.4; 86.7; 69.9; 39.8; 25.3 | — |
| SECONDARY Percent Change From Baseline for JIA ACR Core Components in TP1 |
-77.4; -53.1; -53.776; -79.3; -72.5 | — |
| SECONDARY Percent Change in C-reactive Protein Standardized Value (mg/L) |
-13.587 | — |
| SECONDARY Change From Baseline Juvenile Arthritis Disease Activity Score (JADAS) Score |
-10.487; -13.403 | — |
| SECONDARY Change From Baseline in Total Enthesitis Events - TP1 (FAS1) |
-1.8 | — |
| SECONDARY Change From Baseline in Total Dactylitis Count |
-0.8 | — |
| SECONDARY Number of Participants With Anti-secukinumab Anitbodies |
0; 0; 0 | — |
| SECONDARY Secukinumab Serum Concentration |
30.9; 34.6 | — |
| SECONDARY Number of Participants With Inactive Disease Status for All Subjects - TP1 (FAS1) |
30 | — |
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of Enthesitis-related arthritis (ERA) or Juvenile psoriatic arthritis (JPsA) according to the International League of Associations for Rheumatology (ILAR) classification criteria of at least 6 months duration.
- Active disease (ERA or JPsA) defined as having both:
- at least 3 active joints
- at least 1 site of active enthesitis at baseline or documented by history.
- Inadequate response (at least 1 month) or intolerance to at least 1 nonsteroidal anti-inflammatory drugs(NSAID)
- Inadequate response (at least 2 months) or intolerance to at least 1 Disease-modifying antirheumatic drugs (DMARD)
- No concomitant use of second line agents such as disease-modifying and/or immunosuppressive drugs.
Exclusion Criteria
- Patients fulfilling any ILAR diagnostic JIA category other than ERA or JPsA.
- Patients who have ever received biologic immunomodulating agents
- Patients taking any non-biologic DMARD except for MTX (or sulfasalazine for ERA patients only).
- Patients with active uncontrolled inflammatory bowel disease or active uncontrolled uveitis.
Other protocol-defined inclusion/exclusion criteria apply.
Data sourced from ClinicalTrials.gov (NCT03031782) 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.