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

April 8, 2024 updated by: Novartis Pharmaceuticals

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

NOTE: Detailed Description : data not entered

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1200
        • Novartis Investigative Site
      • Gent, Belgium, 9000
        • Novartis Investigative Site
  • Germany
      • Freiburg, Germany, 79106
        • Novartis Investigative Site
      • Hamburg, Germany, 22081
        • Novartis Investigative Site
      • Saint Augustin, Germany, 53757
        • Novartis Investigative Site
  • Italy
      • Napoli, Italy, 80131
        • Novartis Investigative Site
    • GE
      • Genova, GE, Italy, 16147
        • Novartis Investigative Site
  • Poland
      • Krakow, Poland, 31503
        • Novartis Investigative Site
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620149
        • Novartis Investigative Site
      • Moscow, Russian Federation, 119991
        • Novartis Investigative Site
      • Saint-Petersburg, Russian Federation, 194100
        • Novartis Investigative Site
      • Voronezh, Russian Federation, 394036
        • Novartis Investigative Site
  • South Africa
      • Cape Town, South Africa, 7925
        • Novartis Investigative Site
    • Western Cape
      • Panorama, Western Cape, South Africa, 7500
        • Novartis Investigative Site
  • Spain
      • Valencia, Spain, 46026
        • Novartis Investigative Site
    • Galicia
      • Santiago De Compostela, Galicia, Spain, 15706
        • Novartis Investigative Site
  • Turkey
      • Ankara, Turkey, 06100
        • Novartis Investigative Site
      • Istanbul, Turkey, 34390
        • Novartis Investigative Site
    • Halkali
      • Istanbul, Halkali, Turkey, 34303
        • Novartis Investigative Site
    • TUR
      • Istanbul, TUR, Turkey, 34098
        • Novartis Investigative Site
  • United States
    • Idaho
      • Boise, Idaho, United States, 83702
        • St Lukes Intermountain Research Center
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Childrens Hospital Division of Rheumatology
    • Oregon
      • Portland, Oregon, United States, 97232
        • Legacy Emanuel Research Hospital Portland Randall Childrens Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with JIA ACR30 response
Time Frame: 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)
308 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2019

Primary Completion (Estimated)

October 3, 2024

Study Completion (Estimated)

November 27, 2024

Study Registration Dates

First Submitted

November 21, 2018

First Submitted That Met QC Criteria

December 6, 2018

First Posted (Actual)

December 7, 2018

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAIN457F2304E1
  • 2018-002521-30 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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