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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03769168
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : March 12, 2020
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
Actual Study Start Date : June 7, 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Locations
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United States, Oregon
Novartis Investigative Site Recruiting
Portland, Oregon, United States, 97232
Belgium
Novartis Investigative Site Recruiting
Bruxelles, Belgium, 1200
Novartis Investigative Site Recruiting
Gent, Belgium, 9000
Germany
Novartis Investigative Site Recruiting
Freiburg, Germany, 79106
Novartis Investigative Site Recruiting
Hamburg, Germany, 22081
Novartis Investigative Site Recruiting
Saint Augustin, Germany, 53757
Italy
Novartis Investigative Site Recruiting
Napoli, Italy, 80131
Poland
Novartis Investigative Site Recruiting
Krakow, Poland, 31503
Russian Federation
Novartis Investigative Site Recruiting
Moscow, Russian Federation, 119991
Novartis Investigative Site Active, not recruiting
Saint-Petersburg, Russian Federation, 194100
Novartis Investigative Site Recruiting
Voronezh, Russian Federation, 394036
Novartis Investigative Site Recruiting
Yekaterinburg, Russian Federation, 620149
Spain
Novartis Investigative Site Recruiting
Santiago de Compostela, Galicia, Spain, 15706
Novartis Investigative Site Active, not recruiting
Valencia, Spain, 46026
Turkey
Novartis Investigative Site Recruiting
Istanbul, TUR, Turkey, 34098
Novartis Investigative Site Recruiting
Ankara, Turkey, 06100
Sponsors and Collaborators
Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03769168    
Other Study ID Numbers: CAIN457F2304E1
2018-002521-30 ( EudraCT Number )
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: March 2020
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
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