Overview

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

Status:
Active, not recruiting
Trial end date:
2024-11-27
Target enrollment:
0
Participant gender:
All
Summary
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Antibodies, Monoclonal
Criteria
Inclusion Criteria:

1. Patient must have participated in core study CAIN457F2304, and must have completed the
entire treatment period up to and including Week 104.

2. Patients must be deemed by the investigator to benefit from continued secukinumab
therapy.

Exclusion Criteria:

1. Plans for administration of live vaccines during the extension study period.

2. Any patient taking other concomitant biologic immunomodulating agent(s) except
secukinumab.

3. 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.