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 PharmaceuticalsInformation Provided by (Responsible Party)
Novartis PharmaceuticalsClinicaltrials.gov Identifier
NCT03769168Other 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 enteredCondition or Disease | Intervention/Treatment |
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Study Design
Study Type | Interventional |
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Actual Enrollment | 55 participants |
Design Allocation | Non-Randomized |
Interventional Model | Single Group Assignment |
Masking | None (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 |
Study Start Date | June 7, 2019 |
Anticipated Primary Completion Date | October 3, 2024 |
Anticipated Study Completion Date | November 27, 2024 |
Groups and Cohorts
Group/ Cohort | Intervention/ Treatment |
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Outcome Measures
Primary Outcome Measures
- 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
- 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) - 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. - 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) - Number of participants with total Enthesitis count [308 weeks] 16 joints will be assessed for tenderness on each side of the body.
- Number of participants with total Dactylitis count [308 weeks] The dactylitis count is the number of fingers and toes presenting with swelling and inflammation.
- 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) |
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Sexes Eligible for Study | All |
Accepts Healthy Volunteers | No |
Inclusion Criteria |
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Exclusion Criteria |
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Contacts and Locations
Sponsors and Collaborators | Novartis Pharmaceuticals |
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Locations |
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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