Status:
COMPLETED
An Extension Study of Subcutaneous Secukinumab in Patients With Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Juvenile Psoriatic Arthritis
Enthesitis Related Arthritis
Eligibility:
All Genders
2-100 years
Phase:
PHASE3
Brief 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) an...
Detailed Description
This study is an extension of a previous core study (NCT03031782 \[CAIN457F2304\]) aiming to assess the long-term efficacy, safety, and tolerability of secukinumab treatment in patients who completed ...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
June 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2024
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT03769168
Start Date
June 7 2019
End Date
November 7 2024
Last Update
October 16 2025
Active Locations (23)
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1
St Lukes Intermountain Research Center
Boise, Idaho, United States, 83702
2
Cincinnati Childrens Hospital
Cincinnati, Ohio, United States, 45229
3
Legacy Emanuel Research Hospital Portland
Portland, Oregon, United States, 97232
4
Novartis Investigative Site
Brussels, Belgium, 1200