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

ClinicalTrials.gov processed this data on August 9, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

ACTIVE, NOT RECRUITING (See Contacts and Locations)
Verified August 2024 by Novartis Pharmaceuticals

Sponsor

Novartis Pharmaceuticals

Information Provided by (Responsible Party)

Novartis Pharmaceuticals

Clinicaltrials.gov Identifier

NCT03769168
Other Study ID Numbers: CAIN457F2304E1
First Submitted: November 21, 2018
First Posted: December 7, 2018
Last Update Posted: August 12, 2024
Last Verified: August 2024
History of Changes

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Study Description

NOTE: Detailed Description : data not entered
Condition or Disease Intervention/Treatment
  • Juvenile Psoriatic Arthritis
  • Enthesitis Related Arthritis
  • Drug: AIN457

Study Design

Study TypeInterventional
Actual Enrollment55 participants
Design AllocationNon-Randomized
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleAn 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
Study Start DateJune 7, 2019
Anticipated Primary Completion DateOctober 3, 2024
Anticipated Study Completion DateNovember 27, 2024

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • 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.
  • 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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)
  2. 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.
  3. 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)
  4. Number of participants with total Enthesitis count [308 weeks]
    16 joints will be assessed for tenderness on each side of the body.
  5. Number of participants with total Dactylitis count [308 weeks]
    The dactylitis count is the number of fingers and toes presenting with swelling and inflammation.
  6. Pharmacokinetics (PK) of secukinumab [308 weeks]
    Concentration of secukinumab in the body

Eligibility Criteria

Ages Eligible for Study 2 Years and Older (Child, Adult, Older Adult)
Sexes Eligible for Study All
Accepts Healthy Volunteers No
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.

Contacts and Locations

Sponsors and Collaborators Novartis Pharmaceuticals
Locations
  • Novartis Investigative Site | Boise, Idaho, United States, 83702
  • Novartis Investigative Site | Cincinnati, Ohio, United States, 45229
  • Novartis Investigative Site | Portland, Oregon, United States, 97232
  • Novartis Investigative Site | Bruxelles, Belgium, 1200
  • Novartis Investigative Site | Gent, Belgium, 9000
  • Novartis Investigative Site | Freiburg, Germany, 79106
  • Novartis Investigative Site | Hamburg, Germany, 22081
  • Novartis Investigative Site | Saint Augustin, Germany, 53757
  • Novartis Investigative Site | Genova, GE, Italy, 16147
  • Novartis Investigative Site | Napoli, Italy, 80131
  • Novartis Investigative Site | Krakow, Poland, 31503
  • Novartis Investigative Site | 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 | Panorama, Western Cape, South Africa, 7500
  • Novartis Investigative Site | Cape Town, South Africa, 7925
  • Novartis Investigative Site | Santiago De Compostela, Galicia, Spain, 15706
  • Novartis Investigative Site | Valencia, Spain, 46026
  • Novartis Investigative Site | Istanbul, Halkali, Turkey, 34303
  • Novartis Investigative Site | Istanbul, TUR, Turkey, 34098
  • Novartis Investigative Site | Ankara, Turkey, 06100
  • Novartis Investigative Site | Istanbul, Turkey, 34390
Investigators

    More Information

    Additional Relevant MeSH Terms

    • Arthritis
    • Arthritis, Psoriatic
    • Enthesopathy
    • Arthritis, Juvenile
    • Joint Diseases
    • Musculoskeletal Diseases
    • Spondylarthropathies
    • Spondylarthritis
    • Spondylitis
    • Spinal Diseases
    • Bone Diseases
    • Psoriasis
    • Skin Diseases, Papulosquamous
    • Skin Diseases
    • Tendinopathy
    • Muscular Diseases
    • Tendon Injuries
    • Wounds and Injuries
    • Rheumatic Diseases
    • Connective Tissue Diseases
    • Autoimmune Diseases
    • Immune System Diseases