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).
Interventions
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.
Study Locations
Contacts
Have a question?
Call 1-888-669-6682 or email [email protected]