An Extension Study of Subcutaneous Secukinumab in Patients With Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA)

An Extension Study of Subcutaneous Secukinumab to Evaluate the Long-term Efficacy, Safety and Tolerability up to 4 Years in Patients With Juvenile Idiopathic Arthritis Subtypes of Juvenile Psoriatic Arthritis and Enthesitis Related Arthritis

ClinicalTrials.gov Identifier: NCT03769168

Novartis Reference Number: CAIN457F2304E1

Last Update: Dec 09, 2020

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

Optional open label, roll over extension study to investigate the efficacy and safety of secukinumab treatment in Juvenile Idiopathic Arthritis (JIA) subtypes of Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA).

Condition

Juvenile Psoriatic Arthritis

Enthesitis Related Arthritis

Phase

Phase 3

Overall status

Recruiting

Enrollment count

58 participants

Start date

Jun 07, 2019

Completion date

Nov 27, 2024

Gender

All

Age(s)

2 Years and older (Child, Adult, Older Adult)

Interventions

Drug

AIN457

Secukinumab (AIN457) is a high-affinity fully human monoclonal anti- human antibody that target IL-17A and neutralizes activity.

Eligibility Criteria

Inclusion Criteria:

Patient must have participated in core study CAIN457F2304, and must have completed the entire treatment period up to and including Week 104.
Patients must be deemed by the investigator to benefit from continued secukinumab therapy.

Exclusion Criteria:

Plans for administration of live vaccines during the extension study period.
Any patient taking other concomitant biologic immunomodulating agent(s) except secukinumab.
Any patient who is deemed not to be benefiting from the study treatment based upon lack of improvement or worsening of their symptoms.

All other protocol related inclusion/exclusion criteria will apply.