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Trial record 1 of 2 for:    secukinumab | Enthesitis Related Arthritis, Juvenile
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An Extension Study of Subcutaneous Secukinumab in Patients With Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA)

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ClinicalTrials.gov Identifier: NCT03769168
Recruitment Status : Not yet recruiting
First Posted : December 7, 2018
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( 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).

Condition or disease Intervention/treatment Phase
Juvenile Psoriatic Arthritis Enthesitis Related Arthritis Drug: AIN457 Phase 3

Detailed Description:
NOTE: Detailed Description : data not entered

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Open-label
Primary Purpose: Treatment
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
Estimated Study Start Date : May 28, 2019
Estimated Primary Completion Date : October 2, 2024
Estimated Study Completion Date : November 27, 2024


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 Name: 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 Name: Secukinumab




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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.

  3. 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)

  4. Number of participants with total Enthesitis count [ Time Frame: 308 weeks ]
    16 joints will be assessed for tenderness on each side of the body.

  5. 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.

  6. Pharmacokinetics (PK) of secukinumab [ Time Frame: 308 weeks ]
    A blood sample to check concentration of secukinumab in the body



Information from the National Library of Medicine

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

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769168


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Sponsors and Collaborators
Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03769168     History of Changes
Other Study ID Numbers: CAIN457F2304E1
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
JIA
JPsA
ERA
Secukinumab
ILAR
Juvenile Psoriatic Arthritis
Enthesitis Related Arthritis
cain457
cain457f

Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Arthritis, Juvenile
Enthesopathy
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
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs