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PURE: A Registry of Patients With Moderate to Severe Plaque Psoriasis

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02786186
Collaborator
(none)
2,362
Enrollment
81
Locations
120.3
Anticipated Duration (Months)
29.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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).

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
2362 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Registry of Patients With Moderate to Severe Chronic Plaque Psoriasis in Canada and Latin AmErica (LACan)
Actual Study Start Date :
Dec 23, 2015
Anticipated Primary Completion Date :
Dec 30, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Secikinumab

Patients treated with secukinumab

Drug: Secikinumab
Other Names:
  • AIN457

    		•
    Approved standard of care

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

    Drug: Secikinumab
    Other Names:
  • AIN457

    		•

    Outcome Measures

    Primary Outcome Measures

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

    1. Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response [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 [Change from Baseline through month 60]

    3. Mean change for Hospital Anxiety and Depression Scale (HADS) score [Change from Baseline through month 60]

    4. Mean change for Psoriasis Symptom Diary (PSD) score [Change from Baseline through month 60]

    5. Mean change for Treatment Satisfaction Scale (TSS) score [Change from Baseline through month 60]

    6. Mean change for Dermatology Life Quality Index (DLQI) score [Change from Baseline through month 60]

    7. Mean change for Psoriasis Epidemiology Screening Tool (PEST) score [Change from Baseline through month 60]

    8. Mean change for direct and indirect cost associated to Psoriasis [Change from Baseline through month 60]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Investigative Site Adrogué Buenos Aires Argentina B1846DTL
    2 Novartis Investigative Site Caba Buenos Aires Argentina C1024AAO
    3 Novartis Investigative Site Caba Buenos Aires Argentina C1181ACH
    4 Novartis Investigative Site Caba Buenos Aires Argentina
    5 Novartis Investigative Site Ciudad Autonoma de Bs As Buenos Aires Argentina C1055AAF
    6 Novartis Investigative Site Ciudad Autonoma de Bs As Buenos Aires Argentina C1425BEA
    7 Novartis Investigative Site Buenos Aires Argentina C1425DKG
    8 Novartis Investigative Site Ciudad Autonoma de Bs As Argentina C1428AAF
    9 Novartis Investigative Site São Paulo SP Brazil 01532000
    10 Novartis Investigative Site Calgary Alberta Canada T3A 2N1
    11 Novartis Investigative Site Edmonton Alberta Canada T5K 1X3
    12 Novartis Investigative Site Edmonton Alberta Canada T6G 1C3
    13 Novartis Investigative Site Nanaimo British Columbia Canada V9T 1W1
    14 Novartis Investigative Site Surrey British Columbia Canada V3R 6A7
    15 Novartis Investigative Site Surrey British Columbia Canada V3V 0C6
    16 Novartis Investigative Site Vancouver British Columbia Canada V5Z 4E8
    17 Novartis Investigative Site Victoria British Columbia Canada V8V 3M9
    18 Novartis Investigative Site Victoria British Columbia Canada V9A 3N7
    19 Novartis Investigative Site Brandon Manitoba Canada R7A 0L5
    20 Novartis Investigative Site Winnepeg Manitoba Canada R3M 1Z9
    21 Novartis Investigative Site Winnipeg Manitoba Canada R3C 0N2
    22 Novartis Investigative Site Winnipeg Manitoba Canada R3M 3Z4
    23 Novartis Investigative Site Fredericton New Brunswick Canada E3B 1G9
    24 Novartis Investigative Site Rothesay New Brunswick Canada E2E 5N4
    25 Novartis Investigative Site Saint John S Newfoundland and Labrador Canada A1C 2H5
    26 Novartis Investigative Site Saint John S Newfoundland and Labrador Canada A1E 1V4
    27 Novartis Investigative Site St Johns Newfoundland and Labrador Canada A1A 4Y3
    28 Novartis Investigative Site St. John's Newfoundland and Labrador Canada A1A 5E8
    29 Novartis Investigative Site Halifax Nova Scotia Canada B3H 1Z2
    30 Novartis Investigative Site Kentville Nova Scotia Canada B4N 4K9
    31 Novartis Investigative Site Barrie Ontario Canada L4M 7G1
    32 Novartis Investigative Site Cobourg Ontario Canada K9A 4J9
    33 Novartis Investigative Site Hamilton Ontario Canada L8N 1V6
    34 Novartis Investigative Site Hamilton Ontario Canada L8N 3Z5
    35 Novartis Investigative Site Hamilton Ontario Canada L9B 1K5
    36 Novartis Investigative Site Kingston Ontario Canada K7L 1B7
    37 Novartis Investigative Site London Ontario Canada N6A 2C2
    38 Novartis Investigative Site London Ontario Canada N6A 3H7
    39 Novartis Investigative Site London Ontario Canada N6H 5L5
    40 Novartis Investigative Site Markham Ontario Canada L3P 1A8
    41 Novartis Investigative Site Mississauga Ontario Canada L4W 0C2
    42 Novartis Investigative Site Mississauga Ontario Canada L5H 1G9
    43 Novartis Investigative Site Nepean Ontario Canada K2G 6E2
    44 Novartis Investigative Site New Market Ontario Canada L3Y 5G8
    45 Novartis Investigative Site Newmarket Ontario Canada L3Y 6P5
    46 Novartis Investigative Site Niagara Falls Ontario Canada L2H 1H5
    47 Novartis Investigative Site North Bay Ontario Canada P1B 3Z7
    48 Novartis Investigative Site North York Ontario Canada M3B 3N1
    49 Novartis Investigative Site Ottawa Ontario Canada K1Y 4E9
    50 Novartis Investigative Site Peterborough Ontario Canada K9J 5K2
    51 Novartis Investigative Site Richmond Hill Ontario Canada L4C 9M7
    52 Novartis Investigative Site Stoney Creek Ontario Canada L8G 1H1
    53 Novartis Investigative Site Sudbury Ontario Canada P3C 1X8
    54 Novartis Investigative Site Toronto Ontario Canada M2M 4J5
    55 Novartis Investigative Site Toronto Ontario Canada M3H 5Y8
    56 Novartis Investigative Site Toronto Ontario Canada M4W 2N2
    57 Novartis Investigative Site Waterloo Ontario Canada N1H 1B1
    58 Novartis Investigative Site Waterloo Ontario Canada N2J 1C4
    59 Novartis Investigative Site Laval Quebec Canada H7N 6L2
    60 Novartis Investigative Site Montreal Quebec Canada H1A 1B9
    61 Novartis Investigative Site Montreal Quebec Canada H3B 3C3
    62 Novartis Investigative Site Montreal Quebec Canada H3H 1V4
    63 Novartis Investigative Site Saint Jerome Quebec Canada J7Z 3B8
    64 Novartis Investigative Site Sainte-Hyacinthe Quebec Canada J2S 66
    65 Novartis Investigative Site Verdun Quebec Canada H4G 3E7
    66 Novartis Investigative Site Saskatoon Saskatchewan Canada S7K O6O
    67 Novartis Investigative Site San Jose San Jose, Costa Rica Costa Rica 10203
    68 Novartis Investigative Site Santiago De Los Caballeros Dominican Republic 51000
    69 Novartis Investigative Site Santo Domingo Dominican Republic 10103
    70 Novartis Investigative Site Guatemala City Ciudad DE Guatemala Guatemala 01010
    71 Novartis Investigative Site Guatemala City Guatemala 01011
    72 Novartis Investigative Site Mexicali Baja California Mexico 21100
    73 Novartis Investigative Site Del Tlalpan Ciudad De Mexico Mexico 14389
    74 Novartis Investigative Site Toluca Estado De Mexico Mexico 50120
    75 Novartis Investigative Site Guadalajara Jalisco Mexico 44636
    76 Novartis Investigative Site San Pedro Garza Garcia Nuevo Leon Mexico 66220
    77 Novartis Investigative Site Monterrey Nuevo León Mexico 64460
    78 Novartis Investigative Site Aguascalientes Mexico 20127
    79 Novartis Investigative Site Guadalajara Jalisco Mexico 44610
    80 Novartis Investigative Site Mexico City Mexico 01030
    81 Novartis Investigative Site Panama Panama

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT02786186
    Other Study ID Numbers:
    • CAIN457ACA02
    First Posted:
    May 30, 2016
    Last Update Posted:
    Jul 22, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Novartis Pharmaceuticals
    Psoriasis
    Plaque Psoriasis
    Chronic Plaque Psoriasis
    Cosentyx
    Secukinumab
    Moderate to severe plaque psoriasis
    PURE registry
    Registry
    Additional relevant MeSH terms:
    Psoriasis

    Study Results

    No Results Posted as of Jul 22, 2022