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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
First received
Last updated
Start date June 7, 2019
Est. completion date November 27, 2024

Study information

Verified date May 2024
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
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.

Study Design


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 Novartis Investigative Site Boise Idaho
United States Cincinnati Childrens Hospital Division of Rheumatology Cincinnati Ohio
United States Novartis Investigative Site 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
See also
  Status Clinical Trial Phase
Recruiting NCT05545839 - Transition to Adulthood Through Coaching and Empowerment in Rheumatology N/A
Completed NCT05252533 - A Study of Ustekinumab in Pediatric Participants (U-POPS) With Juvenile Psoriatic Arthritis or Psoriasis Phase 1
Completed NCT03031782 - Secukinumab Safety and Efficacy in Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related Arthritis (ERA) Phase 3
Recruiting NCT05767047 - A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis Phase 3
Recruiting NCT06100744 - A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab Phase 3
Active, not recruiting NCT04527380 - A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis Phase 3