A Registry of Patients With Moderate to Severe Plaque Psoriasis

Psoriasis Clinical Trial

— PURE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02786186
• Other study ID #: CAIN457ACA02
• Status: Active, not recruiting
• Start date: December 23, 2015
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2362
• Est. completion date: December 31, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Secikinumab

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Adrogué	Buenos Aires
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Ciudad Autonoma de Bs As	Buenos Aires
Argentina	Novartis Investigative Site	Ciudad Autonoma de Bs As	Buenos Aires
Argentina	Novartis Investigative Site	Ciudad Autonoma de Bs As
Brazil	Novartis Investigative Site	São Paulo	SP
Canada	Novartis Investigative Site	Barrie	Ontario
Canada	Novartis Investigative Site	Brandon	Manitoba
Canada	Novartis Investigative Site	Calgary	Alberta
Canada	Novartis Investigative Site	Cobourg	Ontario
Canada	Novartis Investigative Site	Edmonton	Alberta
Canada	Novartis Investigative Site	Edmonton	Alberta
Canada	Novartis Investigative Site	Fredericton	New Brunswick
Canada	Novartis Investigative Site	Halifax	Nova Scotia
Canada	Novartis Investigative Site	Hamilton	Ontario
Canada	Novartis Investigative Site	Hamilton	Ontario
Canada	Novartis Investigative Site	Hamilton	Ontario
Canada	Novartis Investigative Site	Kentville	Nova Scotia
Canada	Novartis Investigative Site	Kingston	Ontario
Canada	Novartis Investigative Site	Laval	Quebec
Canada	Novartis Investigative Site	London	Ontario
Canada	Novartis Investigative Site	London	Ontario
Canada	Novartis Investigative Site	London	Ontario
Canada	Novartis Investigative Site	Markham	Ontario
Canada	Novartis Investigative Site	Mississauga	Ontario
Canada	Novartis Investigative Site	Mississauga	Ontario
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Nanaimo	British Columbia
Canada	Novartis Investigative Site	Nepean	Ontario
Canada	Novartis Investigative Site	New Market	Ontario
Canada	Novartis Investigative Site	Newmarket	Ontario
Canada	Novartis Investigative Site	Niagara Falls	Ontario
Canada	Novartis Investigative Site	North Bay	Ontario
Canada	Novartis Investigative Site	North York	Ontario
Canada	Novartis Investigative Site	Ottawa	Ontario
Canada	Novartis Investigative Site	Peterborough	Ontario
Canada	Novartis Investigative Site	Richmond Hill	Ontario
Canada	Novartis Investigative Site	Rothesay	New Brunswick
Canada	Novartis Investigative Site	Saint Jerome	Quebec
Canada	Novartis Investigative Site	Saint John S	Newfoundland and Labrador
Canada	Novartis Investigative Site	Sainte-Hyacinthe	Quebec
Canada	Novartis Investigative Site	Saskatoon	Saskatchewan
Canada	Novartis Investigative Site	St Johns	Newfoundland and Labrador
Canada	Novartis Investigative Site	St Johns	Newfoundland and Labrador
Canada	Novartis Investigative Site	St. John's	Newfoundland and Labrador
Canada	Novartis Investigative Site	Stoney Creek	Ontario
Canada	Novartis Investigative Site	Sudbury	Ontario
Canada	Novartis Investigative Site	Surrey	British Columbia
Canada	Novartis Investigative Site	Surrey	British Columbia
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Vancouver	British Columbia
Canada	Novartis Investigative Site	Verdun	Quebec
Canada	Novartis Investigative Site	Victoria	British Columbia
Canada	Novartis Investigative Site	Victoria	British Columbia
Canada	Novartis Investigative Site	Waterloo	Ontario
Canada	Novartis Investigative Site	Waterloo	Ontario
Canada	Novartis Investigative Site	Winnepeg	Manitoba
Canada	Novartis Investigative Site	Winnipeg	Manitoba
Canada	Novartis Investigative Site	Winnipeg	Manitoba
Costa Rica	Novartis Investigative Site	San Jose	San Jose, Costa Rica
Dominican Republic	Novartis Investigative Site	Santiago De Los Caballeros
Dominican Republic	Novartis Investigative Site	Santo Domingo
Guatemala	Novartis Investigative Site	Guatemala City	Ciudad DE Guatemala
Guatemala	Novartis Investigative Site	Guatemala City
Mexico	Novartis Investigative Site	Aguascalientes
Mexico	Novartis Investigative Site	Del Tlalpan	Ciudad De Mexico
Mexico	Novartis Investigative Site	Guadalajara	Jalisco
Mexico	Novartis Investigative Site	Guadalajara Jalisco
Mexico	Novartis Investigative Site	Mexicali	Baja California
Mexico	Novartis Investigative Site	Mexico City
Mexico	Novartis Investigative Site	Monterrey	Nuevo León
Mexico	Novartis Investigative Site	San Pedro Garza Garcia	Nuevo Leon
Mexico	Novartis Investigative Site	Toluca	Estado De Mexico
Panama	Novartis Investigative Site	Panama

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Argentina,  Brazil,  Canada,  Costa Rica,  Dominican Republic,  Guatemala,  Mexico,  Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Mean change for Work Productivity and Activity Impairment (WPAI) score		Change from Baseline through month 60
Secondary	Mean change for Hospital Anxiety and Depression Scale (HADS) score		Change from Baseline through month 60
Secondary	Mean change for Psoriasis Symptom Diary (PSD) score		Change from Baseline through month 60
Secondary	Mean change for Treatment Satisfaction Scale (TSS) score		Change from Baseline through month 60
Secondary	Mean change for Dermatology Life Quality Index (DLQI) score		Change from Baseline through month 60
Secondary	Mean change for Psoriasis Epidemiology Screening Tool (PEST) score		Change from Baseline through month 60
Secondary	Mean change for direct and indirect cost associated to Psoriasis		Change from Baseline through month 60