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

Study Overview
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Brief Summary
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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
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NOTE: Detailed Description : data not entered

Official Title
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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

Conditions
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Juvenile Psoriatic Arthritis, Enthesitis Related Arthritis

Intervention / Treatment
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* Drug: AIN457


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must have participated in core study CAIN457F2304, and must have completed the entire treatment period up to and including Week 104. Patients must be deemed by the investigator to benefit from continued secukinumab therapy. Exclusion Criteria: Plans for administration of live vaccines during the extension study period. Any patient taking other concomitant biologic immunomodulating agent(s) except secukinumab. Any patient who is deemed not to be benefiting from the study treatment based upon lack of improvement or worsening of their symptoms. All other protocol related inclusion/exclusion criteria will apply.

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 - Secukinumab 75 mg<br>Group 1 - Secukinumab (AIN457) 75 mg/0.5mL | Drug: AIN457<br>* Secukinumab (AIN457) is a high-affinity fully human monoclonal anti- human antibody that target IL-17A and neutralizes activity.<br>* Other names: Secukinumab;|
| Experimental: Group 2 - Secukinumab 150 mg<br>Group 2 - Secukinumab (AIN457) 150 mg/1.0mL | Drug: AIN457<br>* Secukinumab (AIN457) is a high-affinity fully human monoclonal anti- human antibody that target IL-17A and neutralizes activity.<br>* Other names: Secukinumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with JIA ACR30 response | JIA ACR 30 is defined as 30% improvement from baseline in a minimum of three out of six variables with no more than one variable worsening more than 30% as defined in the ACR criteria. The six variables assessed in order to calculate JIA ACR 30 are: Physician global assessment of overall disease activity Parent's or patients' global assessment of patient's overall well-being Functional ability (CHAQ: Childhood Health Assessment Questionnaire) Number of joints with active arthritis Number of joint with limited range of motion Index of inflammation: C-reactive Protein (CRP) | 308 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with JIA ACR 50/70/90/100 response | JIA ACR 50/70/90/100 are defined as 50%, 70%, 90% and 100% improvement from baseline respectively in a minimum of three out of six variables with no more than one variable worsening more than 50%, 70%, 90% and 100% respectively, as defined in the ACR criteria. The six variables assessed in order to calculate JIA ACR responses are: Physician global assessment of overall disease activity Parent's or patients' global assessment of patient's overall well-being Functional ability (CHAQ: Childhood Health Assessment Questionnaire) Number of joints with active arthritis Number of joint with limited range of motion Index of inflammation: C-reactive Protein (CRP) | 308 weeks | 
| Number of participants with inactive disease status | In order for inactive disease to be confirmed in a patient when all the following conditions are met: No joints with active arthritis No uveitis CRP value within normal limits for the laboratory where tested or, if elevated, not attributable to JIA Physician's global assessment of disease activity score ≤ 10mm Duration of morning stiffness attributable to JIA lasting ≥15 minutes. | 308 weeks | 
| Number of participants with Juvenile Arthritis Disease Activity Score (JADAS) | JADAS will be derived from the following assessments: Physician global assessment of overall disease activity Parent's or patients' global assessment of patient's overall well-being Number of joints with active arthritis Tender and swollen joint counts Index of inflammation: C-reactive Protein (CRP) | 308 weeks | 
| Number of participants with total Enthesitis count | 16 joints will be assessed for tenderness on each side of the body. | 308 weeks | 
| Number of participants with total Dactylitis count | The dactylitis count is the number of fingers and toes presenting with swelling and inflammation. | 308 weeks | 
| Pharmacokinetics (PK) of secukinumab | Concentration of secukinumab in the body | 308 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERA, JIA, JPsA, Secukinumab, ILAR, Juvenile Psoriatic Arthritis, Enthesitis Related Arthritis, cain457, cain457f