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NCT Number: NCT02786186

A Registry of Patients With Moderate to Severe Plaque Psoriasis

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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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Edmonton, Alberta, Canada

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • - 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.

Exclusion criteria

  • - 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.

Treatment and study plan

Secikinumab

Drug

Other names: AIN457

Primary outcomes

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

    Time frame: Change from Baseline through month 60

    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

Secondary outcomes

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

    Time frame: Change from Baseline through month 60

    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)

  2. Mean change for Work Productivity and Activity Impairment (WPAI) score

    Time frame: Change from Baseline through month 60

  3. Mean change for Hospital Anxiety and Depression Scale (HADS) score

    Time frame: Change from Baseline through month 60

  4. Mean change for Psoriasis Symptom Diary (PSD) score

    Time frame: Change from Baseline through month 60

  5. Mean change for Treatment Satisfaction Scale (TSS) score

    Time frame: Change from Baseline through month 60

  6. Mean change for Dermatology Life Quality Index (DLQI) score

    Time frame: Change from Baseline through month 60

  7. Mean change for Psoriasis Epidemiology Screening Tool (PEST) score

    Time frame: Change from Baseline through month 60

  8. Mean change for direct and indirect cost associated to Psoriasis

    Time frame: Change from Baseline through month 60

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: PURE

Important dates

Study start
2015
Primary completion
2026
Study completion
2026
First posted
May 30, 2016
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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