Juvenile Idiopathic Arthritis sub-types
Enthesitis-Related Arthritis (ERA) or Juvenile Psoriatic Arthritis (PSA) subtypes of JIA
This is 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 is 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.
|Ages Eligible for Study:
||2 Years to 17 Years (Child)
- 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.
- 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.
Principal Investigator Name
Daniel Kingsbury, MD
Thursday, December 21, 2017 03:55:28 PM