Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main purpose of the current study will be to provide real - world evidence regarding the safety and effectiveness of secukinumab in the management of patients with moderate to severe chronic plaque psoriasis.
PURE is a multi-national, prospective, observational cohort study of patients with moderate to severe chronic plaque psoriasis aimed at assessing the real-world safety and effectiveness of secukinumab and other indicated therapies. The study will enroll patients for whom, prior to and independent of study enrollment, the treating physician has decided to treat with secukinumab, or one of the other indicated therapies regimens approved for the management of moderate to severe chronic plaque psoriasis.
Two study cohorts will be defined by patients treated with secukinumab (Cohort 1), and patients treated with other indicated therapies (systemic, phototherapy, or biologic therapy; Cohort 2). Each investigator will recruit approximately the same number of patients in each treatment arm. 2,500 patients (1,250 patients in each cohort) will be followed over a period of 5 years from the Baseline assessment (Visit 1).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secikinumab | Patients treated with secukinumab |
| |
| Approved standard of care | Patients treated with other indicated therapies (systemic, phototherapy, or biologic therapy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secikinumab | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Incidence of all adverse events in the study cohorts as measured by:
| Change from Baseline through month 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response | PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head: 0.1, arms: 0.2 body: 0.3 legs: 0.4) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patient with moderate to severe plaque psoriasis
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Edmonton | Alberta | T6G 1C3 | Canada | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36496547 | Derived | Papp KA, Gooderham M, Dei-Cas I, LopezTello A, Garcia-Rodriguez JC, Taveras CY, Rousselin AH, Lavieri A, Maiolino M, Quintero DGV, Rihakova L, Salibe M, Pertuz W. Effectiveness and Safety of Secukinumab in Latin American Patients with Moderate to Severe Plaque Psoriasis: PURE Registry 12-Month Data. Dermatol Ther (Heidelb). 2023 Jan;13(1):269-283. doi: 10.1007/s13555-022-00849-0. Epub 2022 Dec 10. | |
| 31226985 |
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C555450 | secukinumab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Change from Baseline through month 60 |
| Mean change for Work Productivity and Activity Impairment (WPAI) score | Change from Baseline through month 60 |
| Mean change for Hospital Anxiety and Depression Scale (HADS) score | Change from Baseline through month 60 |
| Mean change for Psoriasis Symptom Diary (PSD) score | Change from Baseline through month 60 |
| Mean change for Treatment Satisfaction Scale (TSS) score | Change from Baseline through month 60 |
| Mean change for Dermatology Life Quality Index (DLQI) score | Change from Baseline through month 60 |
| Mean change for Psoriasis Epidemiology Screening Tool (PEST) score | Change from Baseline through month 60 |
| Mean change for direct and indirect cost associated to Psoriasis | Change from Baseline through month 60 |
| Nanaimo |
| British Columbia |
| V9T 1W1 |
| Canada |
| Novartis Investigative Site | Surrey | British Columbia | V3R 6A7 | Canada |
| Novartis Investigative Site | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Novartis Investigative Site | Brandon | Manitoba | R7A 0L5 | Canada |
| Novartis Investigative Site | Winnepeg | Manitoba | R3M1Z9 | Canada |
| Novartis Investigative Site | Winnipeg | Manitoba | R3C 0N2 | Canada |
| Novartis Investigative Site | Fredericton | New Brunswick | E3B 1G9 | Canada |
| Novartis Investigative Site | St. John's | Newfoundland and Labrador | A1A 4Y3 | Canada |
| Novartis Investigative Site | St. John's | Newfoundland and Labrador | A1C 2H5 | Canada |
| Novartis Investigative Site | Hamilton | Ontario | L8N 3Z5 | Canada |
| Novartis Investigative Site | London | Ontario | N6A 3H7 | Canada |
| Novartis Investigative Site | Nepean | Ontario | K2G 6E2 | Canada |
| Derived |
| Papp KA, Gooderham M, Beecker J, Lynde CW, Delorme I, Dei-Cas I, Albrecht L, Rampakakis E, Sampalis JS, Vieira A, Hussein S, Chambenoit O, Rihakova L. Rationale, objectives and design of PURE, a prospective registry of patients with moderate to severe chronic plaque psoriasis in Canada and Latin America. BMC Dermatol. 2019 Jun 21;19(1):9. doi: 10.1186/s12895-019-0087-3. |