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JIA sub-types

Trial

Clinical Trial Title

Juvenile Idiopathic Arthritis sub-types

Trial Status

Open to Enrollment

Start Date

September 1, 2017

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

Principal Investigator Name

Daniel Kingsbury, MD

Contact Name

Kristiin Hickey

Phone

503-413-5447

Contact Fax

503-413-3543

Contact E-Mail

khickey@lhs.org

Last Updated: Thursday, September 21, 2017 07:43:26 AM