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

PHASE3CompletedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

June 7, 2019

Primary Completion Date

November 7, 2024

Study Completion Date

November 7, 2024

Conditions
Juvenile Psoriatic ArthritisEnthesitis Related Arthritis
Interventions
DRUG

Secukinumab

Secukinumab solution for subcutaneous injections was provided in PFS. Initially, participants continued to receive secukinumab at either 75 mg (in 0.5mL) or 150 mg (in 1mL) every 4 weeks, consistent with their dosage at the Week 100 visit of the core study. The dose could be escalated from 75 mg to 150 mg for patients whose signs and symptoms were not fully controlled, as judged by the investigator, with the current 75 mg dose. Furthermore, the dose could also be escalated to 300 mg every 4 weeks for patients weighing 50kg and over who were currently on the 150 mg dose and whose signs and symptoms were not well-controlled, as judged by the investigator. The dose escalation from secukinumab 75 mg to 300 mg was to be implemented in two steps (first 150 mg and then 300 mg based on the investigator's judgment). At each study treatment time point, one or two subcutaneous injections in the form of PFS were administered.

Trial Locations (23)

1200

Novartis Investigative Site, Brussels

7500

Novartis Investigative Site, Panorama

7925

Novartis Investigative Site, Cape Town

9000

Novartis Investigative Site, Ghent

15706

Novartis Investigative Site, Santiago de Compostela

16147

Novartis Investigative Site, Genova

22081

Novartis Investigative Site, Hamburg

31503

Novartis Investigative Site, Krakow

34093

Novartis Investigative Site, Istanbul

34098

Novartis Investigative Site, Istanbul

34303

Novartis Investigative Site, Istanbul

45229

Cincinnati Childrens Hospital, Cincinnati

46026

Novartis Investigative Site, Valencia

53757

Novartis Investigative Site, Saint Augustin

79106

Novartis Investigative Site, Freiburg im Breisgau

80131

Novartis Investigative Site, Napoli

83702

St Lukes Intermountain Research Center, Boise

97232

Legacy Emanuel Research Hospital Portland, Portland

119991

Novartis Investigative Site, Moscow

194100

Novartis Investigative Site, Saint Petersburg

394036

Novartis Investigative Site, Voronezh

620149

Novartis Investigative Site, Yekaterinburg

06230

Novartis Investigative Site, Ankara

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY