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

Juvenile Psoriatic Arthritis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03769168
• Other study ID #: CAIN457F2304E1
• Secondary ID: 2018-002521-30
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 7, 2019
• Est. completion date: November 27, 2024

Study information

• Verified date: April 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

NOTE: Detailed Description : data not entered

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 55
• Est. completion date: November 27, 2024
• Est. primary completion date: October 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Arthritis, Psoriatic
• Enthesitis Related Arthritis
• Enthesopathy
• Juvenile Psoriatic Arthritis

Intervention

Drug:
• AIN457
Secukinumab (AIN457) is a high-affinity fully human monoclonal anti- human antibody that target IL-17A and neutralizes activity.

Locations

Country	Name	City	State
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Gent
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Saint Augustin
Italy	Novartis Investigative Site	Genova	GE
Italy	Novartis Investigative Site	Napoli
Poland	Novartis Investigative Site	Krakow
Russian Federation	Novartis Investigative Site	Ekaterinburg
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Saint-Petersburg
Russian Federation	Novartis Investigative Site	Voronezh
South Africa	Novartis Investigative Site	Cape Town
South Africa	Novartis Investigative Site	Panorama	Western Cape
Spain	Novartis Investigative Site	Santiago De Compostela	Galicia
Spain	Novartis Investigative Site	Valencia
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Istanbul
Turkey	Novartis Investigative Site	Istanbul	Halkali
Turkey	Novartis Investigative Site	Istanbul	TUR
United States	St Lukes Intermountain Research Center	Boise	Idaho
United States	Cincinnati Childrens Hospital Division of Rheumatology	Cincinnati	Ohio
United States	Legacy Emanuel Research Hospital Portland Randall Childrens Hospital	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  Italy,  Poland,  Russian Federation,  South Africa,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Number of participants with total Enthesitis count	16 joints will be assessed for tenderness on each side of the body.	308 weeks
Secondary	Number of participants with total Dactylitis count	The dactylitis count is the number of fingers and toes presenting with swelling and inflammation.	308 weeks
Secondary	Pharmacokinetics (PK) of secukinumab	Concentration of secukinumab in the body	308 weeks