Secukinumab Safety and Efficacy in JPsA and ERA

Status:	Recruiting
Conditions:	Arthritis
Therapuetic Areas:	Rheumatology
Healthy:	No
Age Range:	2 - 17
Updated:	3/13/2019
Start Date:	May 23, 2017
End Date:	December 30, 2020
Contact:	Novartis Pharmaceuticals
Email:	Novartis.email@novartis.com
Phone:	1-888-669-6682

A Three-part Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Secukinumab Treatment in Juvenile Idiopathic Arthritis Subtypes of Psoriatic and Enthesitis-related Arthritis

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.

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.

We found this trial at

sites

Novartis

Portland, Oregon 97228