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A Registry of Patients With Moderate to Severe Plaque Psoriasis

NCT ID: NCT02786186

Last Updated: 2024-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

2384 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-23

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Psoriasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Secikinumab

Patients treated with secukinumab

Secikinumab

Intervention Type DRUG

Approved standard of care

Patients treated with other indicated therapies (systemic, phototherapy, or biologic therapy)

Secikinumab

Intervention Type DRUG

Interventions

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Secikinumab

Intervention Type DRUG

Other Intervention Names

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AIN457

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novartis Investigative Site

Adrogué, Buenos Aires, Argentina

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Novartis Investigative Site

Caba, Buenos Aires, Argentina

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CABA, Buenos Aires, Argentina

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CABA, Buenos Aires, Argentina

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Ciudad Autonoma de Bs As, Buenos Aires, Argentina

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Ciudad Autonoma de Bs As, Buenos Aires, Argentina

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Novartis Investigative Site

Buenos Aires, , Argentina

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Ciudad Autonoma de Bs As, , Argentina

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São Paulo, São Paulo, Brazil

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Edmonton, Alberta, Canada

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Nanaimo, British Columbia, Canada

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Surrey, British Columbia, Canada

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Surrey, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Victoria, British Columbia, Canada

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Victoria, British Columbia, Canada

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Brandon, Manitoba, Canada

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Winnepeg, Manitoba, Canada

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Winnipeg, Manitoba, Canada

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Winnipeg, Manitoba, Canada

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Fredericton, New Brunswick, Canada

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Rothesay, New Brunswick, Canada

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St. John's, Newfoundland and Labrador, Canada

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St. John's, Newfoundland and Labrador, Canada

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St. John's, Newfoundland and Labrador, Canada

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St. John's, Newfoundland and Labrador, Canada

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Halifax, Nova Scotia, Canada

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Kentville, Nova Scotia, Canada

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Barrie, Ontario, Canada

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Cobourg, Ontario, Canada

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Greater Sudbury, Ontario, Canada

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Hamilton, Ontario, Canada

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Hamilton, Ontario, Canada

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Hamilton, Ontario, Canada

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London, Ontario, Canada

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London, Ontario, Canada

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London, Ontario, Canada

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Markham, Ontario, Canada

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Mississauga, Ontario, Canada

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Mississauga, Ontario, Canada

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Nepean, Ontario, Canada

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Newmarket, Ontario, Canada

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Newmarket, Ontario, Canada

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Niagara Falls, Ontario, Canada

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North Bay, Ontario, Canada

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North York, Ontario, Canada

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Ottawa, Ontario, Canada

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Peterborough, Ontario, Canada

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Richmond Hill, Ontario, Canada

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Stoney Creek, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Waterloo, Ontario, Canada

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Waterloo, Ontario, Canada

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Laval, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Saint-Jérôme, Quebec, Canada

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Sainte Hyacinthe, Quebec, Canada

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Verdun, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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San José, , Costa Rica

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Santiago de los Caballeros, , Dominican Republic

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Santo Domingo, , Dominican Republic

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Guatemala City, Ciudad de Guatemala, Guatemala

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Guatemala City, , Guatemala

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Mexicali, Estado de Baja California, Mexico

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Guadalajara, Jalisco, Mexico

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Del Tlalpan, Mexico City, Mexico

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Guadalajara Jalisco, Mexico, Mexico

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Monterrey, Nuevo León, Mexico

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San Pedro Garza García, Nuevo León, Mexico

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Toluca, State of Mexico, Mexico

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Aguascalientes, , Mexico

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Mexico City, , Mexico

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Novartis Investigative Site

Panama City, , Panama

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Countries

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Argentina Brazil Canada Costa Rica Dominican Republic Guatemala Mexico Panama

References

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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.

Reference Type DERIVED
PMID: 36496547 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31226985 (View on PubMed)

Other Identifiers

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CAIN457ACA02

Identifier Type: -

Identifier Source: org_study_id

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