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

Part of paid clinical trials in Boise, Idaho.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03769168
Phase
PHASE3
Status
Completed

Conditions

  • Enthesitis Related Arthritis
  • Juvenile Psoriatic Arthritis

Eligibility Criteria

Sex
ALL
Age
2 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Secukinumab — DRUG
    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.

Study Details

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).

Key Dates

Start date
Jun 7, 2019
Status verified
Oct 2025
Primary completion
Nov 7, 2024
Completion
Nov 7, 2024

Study Design

Enrollment
55 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1- Secukinumab 75 mg
    Participants initially received secukinumab 75mg subcutaneously once every four weeks in the extension study. If the signs and symptoms of the participants were not adequately controlled with the 75mg dose, as determined by the investigator, the dose could be escalated to 150mg subcutaneously. For patients weighing 50kg and over, the dose could further be escalated to 300mg subcutaneously every four weeks. The dose escalation from secukinumab 75mg subcutaneously to 300mg subcutaneously was to be implemented in two steps, with the first step being an increase to 150mg subcutaneously, followed by another escalation to 300mg subcutaneously, based on the judgement of the investigator.
  • Experimental: Group 2 - Secukinumab 150 mg
    Participants initially received secukinumab 150mg subcutaneously once every four weeks in the extension study. If the signs and symptoms of the participants were not adequately controlled with the 150mg dose, as determined by the investigator, the dose could be escalated to 300mg subcutaneously.

Primary Outcome Measure

Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response [ Time Frame: 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. ]

Locations (3)

FacilityCityStateZIPSite coordinators
St Lukes Intermountain Research CenterBoiseIdaho83702-
Cincinnati Childrens HospitalCincinnatiOhio45229-
Legacy Emanuel Research Hospital PortlandPortlandOregon97232-

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By research site
St Lukes Intermountain Research Center· Boise, IDCincinnati Childrens Hospital· Cincinnati, OHLegacy Emanuel Research Hospital Portland· Portland, OR

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