Secukinumab Safety and Efficacy in Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related Art… (NCT03031782) | Clinical Trial Compass
CompletedPhase 3
Secukinumab Safety and Efficacy in Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related Arthritis (ERA)
United States, Belgium86 participantsStarted 2017-05-23
Plain-language 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
Who can participate
Age range2 Years – 17 Years
SexALL
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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:
✓. 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).
What they're measuring
1
Number of Participants Experiencing a Flare During Treatment Period 2