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Regulatory Post-Marketing Surveillance in hidradenitis suppurativa, pediatric plaque psoriasis and JIA treated with Cosentyx®(secukinumab) in Korea
This post-marketing study is a multicenter, single-arm, prospective, observational study.
Cosentyx is prescribed within the scope of the approved indications for hidradenitis suppurativa, pediatric plaque psoriasis, enthesitis-related arthritis and juvenile psoriatic arthritis in the juvenile idiopathic arthritis category. The decision to treat patients with the drug will be made within current clinical practice and will be clearly distinguished from the decision to include patients in this investigation. No additional diagnostics or monitoring will be performed for this study beyond what is typically performed in clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secukinumab - HS | Participants with Hidradenitis Supurativa who are receiving or will receive Cosentyx after the start of this study in routine clinical practice. |
| |
| Secukinumab - Pediatric plaque psoriasis | Participants with pediatric plaque psoriasis who are receiving or will receive Cosentyx after the start of this study in routine clinical practice. |
| |
| Secukinumab - JIA | Participants with juvenile idiopathic arthritis who are receiving or will receive Cosentyx after the start of this study in routine clinical practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secukinumab | Drug | This is a prospective observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants having Adverse Events (AEs) and Serious Adverse Events (SAEs) within each indication | All AEs, regardless of severity or causality, will be collected from all participants enrolled in the study. | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of paticipants achieving 50% reduction in hidradenitis suppurativa clinical response (HiSCR50) - HS participants | The HiSCR is a validated assessment tool developed for patients with hidradenitis suppurativa. It is a dichotomized clinical response assessment that measures the status of three types of lesions: abscesses, inflammatory nodules, and draining fistulas. HiSCR50 is defined as participants who have at least a 50% reduction in abscess and nodule count compared to baseline and no increase in the number of abscesses or draining tunnels. |
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Inclusion Criteria:
Hidradenitis suppurativa:
Pediatric plaque psoriasis:
Juvenile idiopathic arthritis:
Exclusion Criteria:
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Patients who are receiving or will receive Cosentyx after the start of this study in routine clinical practice.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | +41613241111 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Recruiting | Seoul | Seoul | 06973 | South Korea |
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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|
| 12 and 24 weeks |
| Proportion of participants achieving a severity of 0 or 1 on the hidradenitis supurativa-physician's global assessment (HS-PGA) - HS participants | The HS-PGA is a global assessment of patients with hidradenitis suppurativa based on four clinical assessments [number of abscesses, number of draining fistulas, number of inflammatory nodules, and presence/absence of non-inflammatory nodules] to determine severity on a six-point scale, scores range from 0-5 based on the number of HS lesions ranges from clear to very severe. | 12 and 24 weeks |
| Proportion of participants with a 55% or greater reduction in international hidradenitis suppurativa severity scoring system (IHS4-55) - HS participants | The IHS4 is an exclusively physician-based, clinical scoring system for dynamic assessment of HS severity. HS severity is calculated based on the number of lesions multiplied by their respective score: the IHS4 score (points) = (number of nodules multiplied by 1) + (number of abscesses multiplied by 2) + [number of draining tunnels (fistulae/sinuses) multiplied by 4]. HS4-55 is defined as participants who have at least a 55% reduction in IHS4 score compared to baseline. | 12 and 24 weeks |
| Proportion of participants with a ≥30% reduction in Hidradenitis suppurativa-related skin pain numerical rating scale (NRS) - HS participants | The HS-related skin pain NRS is a numeric rating scale in which patients rate their pain at the time of the worst skin pain in the past 24 hours. The numeric rating scale is a fine-grained numeric version of a visual analogue scale (VAS) in which respondents select a number (0-10) that best reflects the intensity of their pain, ranging from 0 (no skin pain) to 10 (most severe skin pain) | 12 and 24 weeks |
| Proportion of participants with an Hidradenitis supurativa flare - HS participants | An HS flare is a new or substantial worsening of clinical signs or symptoms. | 12 and 24 weeks |
| Proportion of participants by Hurley stage - HS participants | The Hurley stage is a grading system for classifying the severity of hidradenitis suppurativa. Stage I is defined as abscess formation (single or multiple), no sinus tracts or cicatrization/scarring, Stage II is defined as recurrent abscesses with sinus tracts and scarring, single or multiple separated lesions, and Stage III is defined as diffuse or almost diffuse involvement, or multiple interconnected sinus tracts and abscesses across the entire area. | 12 and 24 weeks |
| Change from baseline in Psoriasis Area and Severity Index (PASI) - Pediatric plaque psoriasis participants | The PASI is a composite index that combines the area of involvement of psoriatic lesions with the severity of the lesions. The PASI calculates the extent of redness/erythema, scaling, and thickness/thickness of psoriatic lesions and assesses their severity with a corresponding score. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0. | 12 and 24 weeks |
| Proportion of participants achieving an Investigator's Global Assessment (IGA) score of 0 or 1 - Pediatric plaque psoriasis participants | The IGA mod 2011 score is used to determine the severity psoriasis symptoms. It reflects a subject's overall disease severity for the whole body. The scale includes 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. | 12 and 24 weeks |
| Change from baseline in active joints by Tender Joint Count (TJC) - JIA participants | A joint is classified as "active" when there is swelling, pain on movement, tenderness/pain on movement, and limitation of motion. It is also possible to classify a joint as "active" if only edema is present. Using digital pressure, joints that feel tender or show pain when moved are considered tender joints, and their counts are totaled to determine the tender joint count (TJC). | 12 and 24 weeks |
| Change from baseline in active joints by swollen joint count (SJC)- JIA participants | A joint is classified as "active" when there is swelling, pain on movement, tenderness/pain on movement, and limitation of motion. It is also possible to classify a joint as "active" if only edema is present. Swollen joint count SJC is determined by physical examination of joint counts that are classified as either swollen or not swollen. | 12 and 24 weeks |
| Change from baseline in clinical juvenile arthritis disease activity score (cJADAS) - JIA participants | The JADAS is a tool for assessing disease activity in Juvenile idiopathic arthritis that is composed of four items: joint count (number of active joints as assessed by a physician), physician global assessment of disease activity (VAS 0-10), parent/patient global assessment (VAS 0-10), and serum inflammatory markers (erythrocyte sedimentation rate (ESR)), which are scored separately and summed to calculate a score. The clinical JADAS (cJADAS) used in this study excludes serum inflammatory markers and is calculated by summing all the scores (0-10) obtained from each item, and the score is calculated from a minimum of 0 to a maximum of 30. | 12 and 24 weeks |
| Physician evaluation of participant symptoms | Treatment effect is evaluated by physician based on clinical judgement and/or laboratory test results and classified in four categories.
| 12 and 24 weeks |
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| D001171 | Arthritis, Juvenile |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C555450 | secukinumab |
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