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A Registry of Patients With Moderate to Severe Plaque Psoriasis (PURE)

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ClinicalTrials.gov Identifier: NCT02786186
Recruitment Status : Recruiting
First Posted : May 30, 2016
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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
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).


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 60 Months
Official Title: A Registry of Patients With Moderate to Severe Chronic Plaque Psoriasis in Canada and Latin AmErica (LACan)
Actual Study Start Date : December 23, 2015
Estimated Primary Completion Date : December 30, 2024
Estimated Study Completion Date : December 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Group/Cohort
Secikinumab
Patients treated with secukinumab
Approved standard of care
Patients treated with other indicated therapies (systemic, phototherapy, or biologic therapy)



Primary Outcome Measures :
  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:

    1. The proportion of patients that experience at least one event;

      and

    2. 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 [ 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with moderate to severe plaque psoriasis
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786186


Contacts
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Contact: Novartis Pharmaceuticals, RN +41613241111 ext 1286 bernard.bourgault@novartis.com
Contact: Novartis Pharmaceuticals, PhD olivier.chambenoit@novartis.com

Locations
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Argentina
Novartis Investigative Site Recruiting
Caba, Buenos Aires, Argentina, C1024AAO
Novartis Investigative Site Completed
Caba, Buenos Aires, Argentina, C1055AAO
Novartis Investigative Site Completed
Caba, Buenos Aires, Argentina, C1062ABK
Novartis Investigative Site Recruiting
Caba, Buenos Aires, Argentina, C1181ACH
Novartis Investigative Site Recruiting
Caba, Buenos Aires, Argentina
Novartis Investigative Site Completed
Caba, Buenos Aires, Argentina
Novartis Investigative Site Recruiting
Ciudad Autonoma de Bs As, Buenos Aires, Argentina, C1055AAF
Novartis Investigative Site Recruiting
Ciudad Autonoma de Bs As, Buenos Aires, Argentina, C1425BEA
Novartis Investigative Site Recruiting
Buenos Aires, Argentina, C1425DKG
Novartis Investigative Site Recruiting
Ciudad Autonoma de Bs As, Argentina, C1428AAF
Brazil
Novartis Investigative Site Completed
São Paulo, SP, Brazil, 01532000
Canada, Ontario
Novartis Investigative Site Recruiting
Peterborough, Ontario, Canada, K9J 5K2
Novartis Investigative Site Recruiting
Waterloo, Ontario, Canada, N2J 1C4
Costa Rica
Novartis Investigative Site Recruiting
San José, San Jose, Costa Rica, Costa Rica
Guatemala
Novartis Investigative Site Recruiting
Guatemala City, Ciudad DE Guatemala, Guatemala, 01010
Novartis Investigative Site Recruiting
Guatemala City, Guatemala, 01011
Mexico
Novartis Investigative Site Recruiting
Mexicali, Baja California, Mexico, 21100
Novartis Investigative Site Recruiting
Del Tlalpan, Ciudad De Mexico, Mexico, 14389
Novartis Investigative Site Recruiting
Toluca, Estado De Mexico, Mexico, 50120
Novartis Investigative Site Recruiting
Guadalajara, Jalisco, Mexico, 44636
Novartis Investigative Site Recruiting
San Pedro Garza Garcia, Nuevo Leon, Mexico, 66220
Novartis Investigative Site Recruiting
Monterrey, Nuevo León, Mexico, 64460
Novartis Investigative Site Completed
Monterrey, Nuevo León, Mexico, 64710
Novartis Investigative Site Recruiting
Aguascalientes, Mexico, 20127
Novartis Investigative Site Recruiting
Guadalajara Jalisco, Mexico, 44610
Sponsors and Collaborators
Novartis Pharmaceuticals

Additional Information:

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02786186     History of Changes
Other Study ID Numbers: CAIN457ACA02
First Posted: May 30, 2016    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Psoriasis
Plaque Psoriasis
Chronic Plaque Psoriasis
Cosentyx
Secukinumab
Moderate to severe plaque psoriasis
PURE registry
Registry

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases