Clinical trial NCT03769168: An Extension Study of Subcutaneous Secukinumab in Patients With Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Juvenile Psoriatic Arthritis
Enthesitis Related Arthritis
Keywords: JIA
JPsA
ERA
Secukinumab
ILAR
Juvenile Psoriatic Arthritis
Enthesitis Related Arthritis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2018-12-07
Enrollment: 55
Sex: ALL
Minimum age (years): 2
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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) and Enthesitis Related Arthritis (ERA).

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 the core study and chose to participate in the extension study. The primary objective was to gather comprehensive data on the efficacy and safety of secukinumab over an extended period.

At Week 104 of the core study, all eligible patients could opt to roll over to the extension study and continue receiving secukinumab at either 75 mg or 150 mg, as they were at the Week 100 visit of the core study. The treatment involved subcutaneous injections using pre-filled syringes (PFS). The duration of patient participation could range from a minimum of one year to a maximum of four years, or until one of the following conditions was met: the drug was locally approved, marketed, and reimbursed, secukinumab could be provided free of charge to patients in compliance with local guidelines, or a maximum of 4 years study duration.

During the extension study (starting from Week 108), to maintain a high proportion of clinically meaningful response during the entire duration of the extension study, the dosing options available, at the Investigator's discretion, were as follows:

* The dose could be escalated from 75 mg to 150 mg for patients whose signs and symptoms were not fully controlled with the current dose of 75 mg and might improve with a higher dose as judged by the investigator
* Further, the dose could be escalated to 300 mg for patients weighing 50 kg and over currently on the 150 mg dose whose signs and symptoms were not fully controlled and might improve further with an increase in dose as judged by the investigator
* Dose escalation from secukinumab 75 mg to 300 mg had to be done in two steps (first 150 mg then 300 mg if the patient weighed 50 kg or over and based on the investigator's judgement), also considering the gap between the two escalations to review the response

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: Percentage of Participants With JIA ACR 50 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.
measure: Percentage of Participants With JIA ACR 70 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.
measure: Percentage of Participants With JIA ACR 90 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.
measure: Percentage of Participants With JIA ACR 100 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.
measure: Number of Participants With Inactive Disease Status
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.
measure: Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity
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.
measure: Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being
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.
measure: Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ)
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.
measure: Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis
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.
measure: Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion
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.
measure: Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels
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.
measure: Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27)
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.
measure: Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71)
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.
measure: Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count
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.
measure: Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count
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.
measure: Serum Concentrations of Secukinumab Over Time
timeFrame: Pre-dose at Week 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
measure: Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) of Secukinumab
timeFrame: From baseline of the core study up to Week 312. Study week is defined with respect to the core study.
Other outcomes:
Locations:
city: Boise
country: United States
facility: St Lukes Intermountain Research Center
state: Idaho
city: Cincinnati
country: United States
facility: Cincinnati Childrens Hospital
state: Ohio
city: Portland
country: United States
facility: Legacy Emanuel Research Hospital Portland
state: Oregon
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Gent
country: Belgium
facility: Novartis Investigative Site
city: Freiburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Saint Augustin
country: Germany
facility: Novartis Investigative Site
city: Genova
country: Italy
facility: Novartis Investigative Site
state: GE
city: Napoli
country: Italy
facility: Novartis Investigative Site
city: Krakow
country: Poland
facility: Novartis Investigative Site
city: Ekaterinburg
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Saint-Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Voronezh
country: Russian Federation
facility: Novartis Investigative Site
city: Panorama
country: South Africa
facility: Novartis Investigative Site
state: Western Cape
city: Cape Town
country: South Africa
facility: Novartis Investigative Site
city: Santiago De Compostela
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Valencia
country: Spain
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
state: Halkali
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
state: TUR
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: