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The goal of this study is to understand the long-term treatment strategies in children and adolescents diagnosed with ERA or JPsA who received secukinumab and achieved inactive disease and to evaluate the long-term treatment effectiveness of secukinumab in the ERA or JPsA patients in the postauthorization setting.
This is a multicenter, non-interventional cohort study with a combined data collection principle based on secondary use of data and primary data collection from the existing BIKER registry among pediatric patients with a recorded diagnosis of ERA or JPsA who have been treated with secukinumab.
The primary objective of this study is to characterize potentially less demanding long-term treatment strategies (e.g., dose tapering, treatment withdrawal followed by treatment re-initiation as needed) and to characterize their effectiveness (evaluated by occurrence of disease flares) in children and adolescents with Enthesitis-Related Arthritis (ERA) or Juvenile Psoriatic Arthritis (JPsA) categories documented in the German Biologics in pediatric rheumatology (BIKER) registry who received secukinumab and achieved inactive disease.
The date of first treatment/prescription of secukinumab will be considered as the index date. The baseline period to evaluate the demographic and clinical characteristics includes the index date and up to 1 year prior to the index date; if no record is available at the index date whichever record is closest to the index date will be used. For JIA-related variables, such as JIA-related manifestations, the evaluation will not have a specific time limit prior to the index date."
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secukinumab | All children and adolescents with ERA or JPsA who received at least one dose of secukinumab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secukinumab | Other | This is an observational study, there is no treatment allocation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who had the following long-term treatment strategy after achieving inactive disease on secukinumab | Number of patients who had the following long-term treatment strategy after achieving inactive disease on secukinumab
| Up to 5 years |
| Number of patients experiencing at least one episode of flare | Number of patients experiencing at least one episode of flare:
| Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with following secukinumab treatment patterns | Number of patients with following secukinumab treatment patterns:
|
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Inclusion Criteria:
Exclusion Criteria:
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Children and adolescents diagnosed with ERA or JPsA JIA categories who received secukinumab
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | +41613241111 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
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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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| every 3 months after index date until end of follow-up, up to 5 years |
| Number of participants by reason for changes to treatment strategy | The reason for changes to treatment strategy:
| every 3 months after index date until end of follow-up, up to 5 years |
| Number of patients achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 criteria at follow-up | The adapted ACR Pediatric 30/50/70/90 criteria was used to determine efficacy defined as improvement from baseline of at least 30/50/70/90% respectively in at least 3 of the following 6 components
| Every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years |
| Number of patients achieving at least minimal disease activity | Patients who achieved minimal disease activity and inactive disease can be defined based on JADAS-10 score. JADAS-10 is a composite disease activity score for JIA including four measures:
| Every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years |
| Number of patients achieving inactive disease | Inactive disease is achieved if either of the following two criteria is fulfilled:
| Every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years |
| Number of patients achieving clinical remission | Patients with 6 consecutive months of inactive disease are defined as entering clinical remission. | Every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years |
| Number of patients achieving complete resolution of dactylitis and enthesitis. | Number of patients achieving complete resolution of dactylitis and enthesitis. | Every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years |
| Change from baseline in pain score | Change from baseline in pain score through numeric rating scale (NRS). Numeric rating scale spans from 0 (no pain) to 10 (strongest pain). | Every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years |
| Change from baseline in JIA ACR criteria individual components | Summary of JIA ACR core components for all subjects and each JIA category. Negative percent change indicates improvement. JIA ACR criteria individual components:
| Every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years |
| Change from baseline in JADAS-10 individual criteria: | JADAS-10 stands for Juvenile Arthritis Disease Activity Score, with up to 10 joints assessed for active arthritis as part of the score. JADAS-10 individual criteria are:
Before calculation, CRP values <10 mg/l were converted to 10 and CRP values >110 mg/l were converted to 110. | Baseline, up to 5 years |
| JADAS-10 score | JADAS-10 stands for Juvenile Arthritis Disease Activity Score, with up to 10 joints assessed for active arthritis as part of the score. The score spans from 0 to 40. Lower values mean lower activity and higher values mean higher activity. | At baseline and every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years |
| Change from baseline in swollen joint count | Change from baseline in swollen joint count | Every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years |
| Change from baseline in tender joint count | Change from baseline in tender joint count | Every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years |
| Total dactylitis count | Total dactylitis count | At baseline and every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years |
| Total enthesitis count | Total enthesitis count, number of affected sites. | At baseline and every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years |
| Enthesitis score | The Enthesitis score using Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) asks for evaluation of swelling and tenderness at different anatomical locations. All locations are scored as 0 "no activity" or 1 "activity". The MASES is the sum of all site scores. | At baseline and every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years |
| Number of participants by JIA-related manifestations | JIA-related manifestations:
| At baseline and every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years |
| Modified Schoeber's test to assess axial mobility (ERA only). | Modified Schober's test is measuring lumbar spine mobility quantitatively. It measures lumbar spine flexion range of motion. To conduct the test, the patient stands upright. The examiner locates the two posterior superior iliac spines and draws a horizontal line between them. A second point is marked 15cm above this line.Then the patient is asked to bend forwards as far as possible whilst keeping the knees fully extended. The distance between the previously marked points is measured again and indicates the amount of flexion. | At baseline and every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years |
| Overall and nocturnal back pain NRS (ERA only). | For patients with Enthesitis-Related Arthritis (ERA), the overall and nocturnal back pain through NRS will be recorded. NRS stands for Numerical Rating Scale: 0 (no pain) to 10 (strongest pain). | At baseline and every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years |
| Skin involvement using the Investigator Global Assessment Modified (IGA Mod) 2011 score (JPsA only). | The IGA Mod is a simple score for the evaluation of psoriasis: 0 = clear (e.g., no signs of psoriasis, some post-inflammatory hyperpigmentation may be present);
| At baseline and every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years |
| Psoriasis Area Severity Index (PASI) (JPsA only). | For patients with Juvenile Psoriatic Arthritis (JPsA), the PASI score will be calculated. The PASI is used for assessing and grading the severity of psoriatic lesions and their response to therapy. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0. | At baseline and every 3 months after index date until the end of follow-up or until secukinumab discontinuation or switching to another biologic, whichever occurs first, up to 5 years |
| Number of participants with relevant JIA-related manifestations | Number of patients with relevant Juvenile Idiopathic Arthritis (JIA)-related manifestations (such as uveitis, serositis) | Baseline |
| Time from symptom onset to diagnosis of ERA or JPsA | Time from symptom onset to diagnosis of Enthesitis-Related Arthritis (ERA) or Juvenile Psoriatic Arthritis (JPsA) | Baseline |
| Disease duration at the time of secukinumab initiation | Disease duration at the time of secukinumab initiation | Baseline |
| Therapy duration prior to start of secukinumab | Therapy duration prior to start of secukinumab (including all drug and non-drug therapies prescribed for ERA or JPsA) | Baseline |
| Number of treatment lines prior to start of secukinumab | Number of treatment lines prior to start of secukinumab | Baseline |
| Prior medication | Prior medication and dosage (including all drug and non-drug therapies prescribed for ERA or JPsA) | Baseline |
| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C555450 | secukinumab |
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