CompletedPhase 3

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

United States, Belgium, Germany55 participantsStarted 2019-06-07

Plain-language 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).

Who can participate

Age range

2 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key Inclusion Criteria: * Patients had to have participated in the core study CAIN457F2304 and completed the entire treatment period up to and including Week 104. * Patients had to be deemed by the investigator to benefit from continued secukinumab therapy. Key Exclusion Criteria: * Patients with plans for administration of live vaccines during the extension study period were excluded. * Patients taking any other concomitant biologic immunomodulating agent(s) except secukinumab were excluded. * Patients who were deemed not to be benefiting from the study treatment based on lack of improvement or worsening of their symptoms were excluded.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response

Timeframe: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.

Trial details

NCT IDNCT03769168

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-07

Results submitted2025-05-02

View on ClinicalTrials.gov More Juvenile Psoriatic Arthritis trials