JIA sub-types

Clinical Trial Title Juvenile Idiopathic Arthritis sub-types
Trial Status Open to Enrollment
Start Date 09/01/2017
Location legacy-emanuel-medical-center
Trial Type Pediatric Rheumatology
Specific Condition Enthesitis-Related Arthritis (ERA) or Juvenile Psoriatic Arthritis (PSA) subtypes of JIA
Description 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.
Eligibility Criteria
Ages Eligible for Study: 2 Years to 17 Years (Child)
Criteria

Inclusion Criteria:

  1. 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.

  2. 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.
  3. Inadequate response (at least 1 month) or intolerance to at least 1 nonsteroidal anti-inflammatory drugs(NSAID)
  4. Inadequate response (at least 2 months) or intolerance to at least 1 Disease-modifying antirheumatic drugs (DMARD)
  5. No concomitant use of second line agents such as disease-modifying and/or immunosuppressive drugs.

Exclusion Criteria:

  1. Patients fulfilling any ILAR diagnostic JIA category other than ERA or JPsA.
  2. Patients who have ever received biologic immunomodulating agents
  3. Patients taking any non-biologic DMARD except for MTX (or sulfasalazine for ERA patients only).
  4. Patients with active uncontrolled inflammatory bowel disease or active uncontrolled uveitis.

Other protocol-defined inclusion/exclusion criteria apply.
IRB Number 10800
Notes https://clinicaltrials.gov/ct2/show/NCT03031782
Principal Investigator Daniel Kingsbury, MD
Contact Name Kristin Hickey
Contact Phone 503-413-5447
Contact Fax 503-413-3543
Contact E-Mail khickey@lhs.org