A Registry of Patients With Moderate to Severe Plaque Psoriasis (PURE)

A Registry of Patients With Moderate to Severe Chronic Plaque Psoriasis in Canada and Latin AmErica (LACan)

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Secikinumab

Detailed Description

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).

• Study Type: Observational
• Enrollment (Actual): 2376

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1C3
      • Novartis Investigative Site
  • British Columbia
    • Nanaimo, British Columbia, Canada, V9T 1W1
      • Novartis Investigative Site
    • Surrey, British Columbia, Canada, V3R 6A7
      • Novartis Investigative Site
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Novartis Investigative Site
  • Manitoba
    • Brandon, Manitoba, Canada, R7A 0L5
      • Novartis Investigative Site
    • Winnepeg, Manitoba, Canada, R3M1Z9
      • Novartis Investigative Site
    • Winnipeg, Manitoba, Canada, R3C 0N2
      • Novartis Investigative Site
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 1G9
      • Novartis Investigative Site
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1A 4Y3
      • Novartis Investigative Site
    • St. John's, Newfoundland and Labrador, Canada, A1C 2H5
      • Novartis Investigative Site
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
      • Novartis Investigative Site
    • London, Ontario, Canada, N6A 3H7
      • Novartis Investigative Site
    • Nepean, Ontario, Canada, K2G 6E2
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient with moderate to severe plaque psoriasis

Description

Inclusion Criteria:

1. - Patients able to give written informed consent
2. - Patients at least 18 years of age at time of informed consent signature
3. - Confirmed diagnosis of chronic moderate to severe chronic plaque-type psoriasis diagnosed by a specialist and presence of moderate to severe psoriasis symptoms according to physician's clinical judgment at the time of recruitment.
4. - Patients initiating a treatment for psoriasis as per regional policy. This will include secukinumab, other biologics, systemic treatments, and phototherapy. Decision to treat with any of the above-mentioned treatments must have been reached prior to and independently of recruitment in the study.
5. - Treatments prescribed in accordance to the product monograph and regional regulatory and reimbursement policies
6. - Patients able to understand and communicate with the investigator and comply with the requirements of the study.

Exclusion Criteria:

1. - Unwillingness or inability to comply with the study requirements
2. - Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Secikinumab; Patients treated with secukinumab	Drug: Secikinumab; Other Names: AIN457
Approved standard of care; Patients treated with other indicated therapies (systemic, phototherapy, or biologic therapy)	Drug: Secikinumab; Other Names: AIN457

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: The proportion of patients that experience at least one event;and; The number of events per participant	Change from Baseline through month 60

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2015
• Primary Completion (Actual): January 22, 2026
• Study Completion (Actual): January 22, 2026

Study Registration Dates

• First Submitted: May 6, 2016
• First Submitted That Met QC Criteria: May 25, 2016
• First Posted (Estimated): May 30, 2016

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Psoriasis; Plaque Psoriasis; Registry; Secukinumab; Chronic Plaque Psoriasis; Cosentyx; Moderate to severe plaque psoriasis; PURE registry
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Psoriasis; secukinumab
• Other Study ID Numbers: CAIN457ACA02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No