A Registry of Patients With Moderate to Severe Plaque Psoriasis

NCT02786186 | Completed FDA Drug

• 1 other identifier: CAIN457ACA02
• Study Type: observational
• Target: 2,376
• Locations: 1 country
• Sites: 13

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.

Conditions

Psoriasis

Keywords

Psoriasis; Plaque Psoriasis; Chronic Plaque Psoriasis; Cosentyx; Secukinumab; Moderate to severe plaque psoriasis; PURE registry; Registry

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Incidence of all adverse events in the study cohorts as measured by: 1. The proportion of patients that experience at least one event; and 2. The number of events per participant

  Change from Baseline through month 60

Secondary Outcomes (8)

• Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response

  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

Study Arms (2)

Secikinumab

Patients treated with secukinumab

Drug: Secikinumab

Approved standard of care

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

Drug: Secikinumab

Interventions

Secikinumab DRUG

Also known as: AIN457

Approved standard of care; Secikinumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with moderate to severe plaque psoriasis

You may qualify if:

• \- Patients able to give written informed consent
• \- Patients at least 18 years of age at time of informed consent signature
• \- 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.
• \- 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.
• \- Treatments prescribed in accordance to the product monograph and regional regulatory and reimbursement policies
• \- Patients able to understand and communicate with the investigator and comply with the requirements of the study.

You may not qualify if:

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (13)

Novartis Investigative Site

Edmonton, Alberta, T6G 1C3, Canada

Location

Novartis Investigative Site

Nanaimo, British Columbia, V9T 1W1, Canada

Location

Novartis Investigative Site

Surrey, British Columbia, V3R 6A7, Canada

Location

Novartis Investigative Site

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Novartis Investigative Site

Brandon, Manitoba, R7A 0L5, Canada

Location

Novartis Investigative Site

Winnepeg, Manitoba, R3M1Z9, Canada

Location

Novartis Investigative Site

Winnipeg, Manitoba, R3C 0N2, Canada

Location

Novartis Investigative Site

Fredericton, New Brunswick, E3B 1G9, Canada

Location

Novartis Investigative Site

St. John's, Newfoundland and Labrador, A1A 4Y3, Canada

Location

Novartis Investigative Site

St. John's, Newfoundland and Labrador, A1C 2H5, Canada

Location

Novartis Investigative Site

Hamilton, Ontario, L8N 3Z5, Canada

Location

Novartis Investigative Site

London, Ontario, N6A 3H7, Canada

Location

Novartis Investigative Site

Nepean, Ontario, K2G 6E2, Canada

Location

Related Publications (2)

• 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.

  PMID: 36496547 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.

  PMID: 31226985 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: May 30, 2016
• Study Start: December 23, 2015
• Primary Completion: January 22, 2026
• Study Completion: January 22, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

CA (13)