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

Phase 3

Completed

• Conditions: Juvenile Psoriatic Arthritis; Enthesitis Related Arthritis
• Interventions: Drug: AIN457

• Registration Number: NCT03769168
• Lead Sponsor: Novartis Pharmaceuticals

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

NOTE: Detailed Description : data not entered

Study Timeline

• Study First Submitted: 2018-11-21
• Study First Submitted QC: 2018-12-06
• Study First Posted: 2018-12-07
• Study Start: 2019-06-07
• Status Verified: 2024-11
• Primary Completion: 2024-11-07
• Study Completion: 2024-11-07
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

1. Patient must have participated in core study CAIN457F2304, and must have completed the entire treatment period up to and including Week 104.
2. Patients must be deemed by the investigator to benefit from continued secukinumab therapy.

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Exclusion Criteria

1. Plans for administration of live vaccines during the extension study period.
2. Any patient taking other concomitant biologic immunomodulating agent(s) except secukinumab.
3. 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 1 - Secukinumab 75 mg	AIN457	Group 1 - Secukinumab (AIN457) 75 mg/0.5mL
Group 2 - Secukinumab 150 mg	AIN457	Group 2 - Secukinumab (AIN457) 150 mg/1.0mL

Primary Outcome Measures

Name	Time	Method
Number of participants with JIA ACR30 response	308 weeks	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)

Secondary Outcome Measures

Name	Time	Method
Number of participants with total Enthesitis count	308 weeks	16 joints will be assessed for tenderness on each side of the body.
Number of participants with inactive disease status	308 weeks	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.
Number of participants with total Dactylitis count	308 weeks	The dactylitis count is the number of fingers and toes presenting with swelling and inflammation.
Pharmacokinetics (PK) of secukinumab	308 weeks	Concentration of secukinumab in the body
Number of participants with JIA ACR 50/70/90/100 response	308 weeks	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)
Number of participants with Juvenile Arthritis Disease Activity Score (JADAS)	308 weeks	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)

Trial Locations

Locations (4)

St Lukes Intermountain Research Center; 🇺🇸 Boise, Idaho, United States

Cincinnati Childrens Hospital; 🇺🇸 Cincinnati, Ohio, United States

Legacy Emanuel Research Hospital Portland; 🇺🇸 Portland, Oregon, United States

Novartis Investigative Site; 🇹🇷 Istanbul, Turkey