Clinical trial NCT02786186: A Registry of Patients With Moderate to Severe Plaque Psoriasis
Official title: A Registry of Patients With Moderate to Severe Chronic Plaque Psoriasis in Canada and Latin AmErica (LACan)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Psoriasis
Keywords: Psoriasis
Plaque Psoriasis
Chronic Plaque Psoriasis
Cosentyx
Secukinumab
Moderate to severe plaque psoriasis
PURE registry
Registry
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2016-05-30
Enrollment: 2384
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with moderate to severe plaque psoriasis

Brief 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Change from Baseline through month 60
Secondary outcomes:
measure: Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
timeFrame: Change from Baseline through month 60
measure: Mean change for Work Productivity and Activity Impairment (WPAI) score
timeFrame: Change from Baseline through month 60
measure: Mean change for Hospital Anxiety and Depression Scale (HADS) score
timeFrame: Change from Baseline through month 60
measure: Mean change for Psoriasis Symptom Diary (PSD) score
timeFrame: Change from Baseline through month 60
measure: Mean change for Treatment Satisfaction Scale (TSS) score
timeFrame: Change from Baseline through month 60
measure: Mean change for Dermatology Life Quality Index (DLQI) score
timeFrame: Change from Baseline through month 60
measure: Mean change for Psoriasis Epidemiology Screening Tool (PEST) score
timeFrame: Change from Baseline through month 60
measure: Mean change for direct and indirect cost associated to Psoriasis
timeFrame: Change from Baseline through month 60
Other outcomes:
Locations:
city: Adrogue
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Ciudad Autonoma de Bs As
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Ciudad Autonoma de Bs As
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Ciudad Autonoma de Bs As
country: Argentina
facility: Novartis Investigative Site
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Calgary
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Edmonton
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Edmonton
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Nanaimo
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Surrey
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Surrey
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Vancouver
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Victoria
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Victoria
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Brandon
country: Canada
facility: Novartis Investigative Site
state: Manitoba
city: Winnepeg
country: Canada
facility: Novartis Investigative Site
state: Manitoba
city: Winnipeg
country: Canada
facility: Novartis Investigative Site
state: Manitoba
city: Winnipeg
country: Canada
facility: Novartis Investigative Site
state: Manitoba
city: Fredericton
country: Canada
facility: Novartis Investigative Site
state: New Brunswick
city: Rothesay
country: Canada
facility: Novartis Investigative Site
state: New Brunswick
city: Saint John S
country: Canada
facility: Novartis Investigative Site
state: Newfoundland and Labrador
city: St Johns
country: Canada
facility: Novartis Investigative Site
state: Newfoundland and Labrador
city: St Johns
country: Canada
facility: Novartis Investigative Site
state: Newfoundland and Labrador
city: St Johns
country: Canada
facility: Novartis Investigative Site
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Novartis Investigative Site
state: Nova Scotia
city: Kentville
country: Canada
facility: Novartis Investigative Site
state: Nova Scotia
city: Barrie
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Cobourg
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Hamilton
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Hamilton
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Hamilton
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: London
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: London
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: London
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Markham
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Mississauga
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Mississauga
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Nepean
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: New Market
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Newmarket
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Niagara Falls
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: North Bay
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: North York
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Ottawa
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Peterborough
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Richmond Hill
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Stoney Creek
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Sudbury
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Waterloo
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Waterloo
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Laval
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Saint Jerome
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Sainte Hyacinthe
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Verdun
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Saskatoon
country: Canada
facility: Novartis Investigative Site
state: Saskatchewan
city: San Jose
country: Costa Rica
facility: Novartis Investigative Site
city: Santiago De Los Caballeros
country: Dominican Republic
facility: Novartis Investigative Site
city: Santo Domingo
country: Dominican Republic
facility: Novartis Investigative Site
city: Guatemala City
country: Guatemala
facility: Novartis Investigative Site
state: Ciudad DE Guatemala
city: Guatemala City
country: Guatemala
facility: Novartis Investigative Site
city: Mexicali
country: Mexico
facility: Novartis Investigative Site
state: Baja California
city: Del Tlalpan
country: Mexico
facility: Novartis Investigative Site
state: Ciudad De Mexico
city: Toluca
country: Mexico
facility: Novartis Investigative Site
state: Estado De Mexico
city: Guadalajara
country: Mexico
facility: Novartis Investigative Site
state: Jalisco
city: San Pedro Garza Garcia
country: Mexico
facility: Novartis Investigative Site
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Novartis Investigative Site
state: Nuevo León
city: Aguascalientes
country: Mexico
facility: Novartis Investigative Site
city: Guadalajara Jalisco
country: Mexico
facility: Novartis Investigative Site
city: Mexico City
country: Mexico
facility: Novartis Investigative Site
city: Panama
country: Panama
facility: Novartis Investigative Site
Study officials:
References:
citation: 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.