A Registry of Patients With Moderate to Severe Plaque Psoriasis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02786186
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Novartis Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Argentina, Brazil, Canada, Costa Rica, Dominican Republic, Guatemala, Mexico
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Additional Details

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).

Arms & Interventions

Arms

: Secikinumab

Patients treated with secukinumab

: Approved standard of care

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

Interventions

Drug: - Secikinumab

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Novartis Investigative Site, Adrogué, Buenos Aires, Argentina

Status

Recruiting

Address

Novartis Investigative Site

Adrogué, Buenos Aires, B1846DTL

Novartis Investigative Site, Caba, Buenos Aires, Argentina

Status

Recruiting

Address

Novartis Investigative Site

Caba, Buenos Aires, C1024AAO

Novartis Investigative Site, Caba, Buenos Aires, Argentina

Status

Withdrawn

Address

Novartis Investigative Site

Caba, Buenos Aires, C1055AAO

Novartis Investigative Site, Caba, Buenos Aires, Argentina

Status

Withdrawn

Address

Novartis Investigative Site

Caba, Buenos Aires, C1062ABK

Novartis Investigative Site, Caba, Buenos Aires, Argentina

Status

Recruiting

Address

Novartis Investigative Site

Caba, Buenos Aires, C1181ACH

Novartis Investigative Site, Caba, Buenos Aires, Argentina

Status

Recruiting

Address

Novartis Investigative Site

Caba, Buenos Aires,

Novartis Investigative Site, Caba, Buenos Aires, Argentina

Status

Withdrawn

Address

Novartis Investigative Site

Caba, Buenos Aires,

Novartis Investigative Site, Ciudad Autonoma de Bs As, Buenos Aires, Argentina

Status

Recruiting

Address

Novartis Investigative Site

Ciudad Autonoma de Bs As, Buenos Aires, C1055AAF

Novartis Investigative Site, Ciudad Autonoma de Bs As, Buenos Aires, Argentina

Status

Recruiting

Address

Novartis Investigative Site

Ciudad Autonoma de Bs As, Buenos Aires, C1425BEA

Novartis Investigative Site, Buenos Aires, Argentina

Status

Recruiting

Address

Novartis Investigative Site

Buenos Aires, , C1425DKG

Novartis Investigative Site, Ciudad Autonoma de Bs As, Argentina

Status

Recruiting

Address

Novartis Investigative Site

Ciudad Autonoma de Bs As, , C1428AAF

Novartis Investigative Site, São Paulo, SP, Brazil

Status

Completed

Address

Novartis Investigative Site

São Paulo, SP, 01532000

Novartis Investigative Site, Calgary, Alberta, Canada

Status

Recruiting

Address

Novartis Investigative Site

Calgary, Alberta, T3A 2N1

Novartis Investigative Site, Edmonton, Alberta, Canada

Status

Recruiting

Address

Novartis Investigative Site

Edmonton, Alberta, T5K 1X3

Novartis Investigative Site, Edmonton, Alberta, Canada

Status

Recruiting

Address

Novartis Investigative Site

Edmonton, Alberta, T6G 1C3

Novartis Investigative Site, Nanaimo, British Columbia, Canada

Status

Recruiting

Address

Novartis Investigative Site

Nanaimo, British Columbia, V9T 1W1

Novartis Investigative Site, Surrey, British Columbia, Canada

Status

Recruiting

Address

Novartis Investigative Site

Surrey, British Columbia, V3R 6A7

Novartis Investigative Site, Surrey, British Columbia, Canada

Status

Recruiting

Address

Novartis Investigative Site

Surrey, British Columbia, V3V 0C6

Novartis Investigative Site, Vancouver, British Columbia, Canada

Status

Recruiting

Address

Novartis Investigative Site

Vancouver, British Columbia, V5Z 4E8

Novartis Investigative Site, Victoria, British Columbia, Canada

Status

Recruiting

Address

Novartis Investigative Site

Victoria, British Columbia, V8V 3M9

Novartis Investigative Site, Victoria, British Columbia, Canada

Status

Terminated

Address

Novartis Investigative Site

Victoria, British Columbia, V9A 3N7

Novartis Investigative Site, Brandon, Manitoba, Canada

Status

Recruiting

Address

Novartis Investigative Site

Brandon, Manitoba, R7A 0L5

Novartis Investigative Site, Winnepeg, Manitoba, Canada

Status

Recruiting

Address

Novartis Investigative Site

Winnepeg, Manitoba, R3M 1Z9

Novartis Investigative Site, Winnipeg, Manitoba, Canada

Status

Recruiting

Address

Novartis Investigative Site

Winnipeg, Manitoba, R3C 0N2

Novartis Investigative Site, Winnipeg, Manitoba, Canada

Status

Recruiting

Address

Novartis Investigative Site

Winnipeg, Manitoba, R3M 3Z4

Novartis Investigative Site, Fredericton, New Brunswick, Canada

Status

Recruiting

Address

Novartis Investigative Site

Fredericton, New Brunswick, E3B 1G9

Novartis Investigative Site, Rothesay, New Brunswick, Canada

Status

Recruiting

Address

Novartis Investigative Site

Rothesay, New Brunswick, E2E 5N4

Novartis Investigative Site, Saint John S, Newfoundland and Labrador, Canada

Status

Recruiting

Address

Novartis Investigative Site

Saint John S, Newfoundland and Labrador, A1C 2H5

Novartis Investigative Site, Saint John S, Newfoundland and Labrador, Canada

Status

Recruiting

Address

Novartis Investigative Site

Saint John S, Newfoundland and Labrador, A1E 1V4

Novartis Investigative Site, St Johns, Newfoundland and Labrador, Canada

Status

Recruiting

Address

Novartis Investigative Site

St Johns, Newfoundland and Labrador, A1A 4Y3

Novartis Investigative Site, St. John's, Newfoundland and Labrador, Canada

Status

Recruiting

Address

Novartis Investigative Site

St. John's, Newfoundland and Labrador, A1A 5E8

Novartis Investigative Site, Halifax, Nova Scotia, Canada

Status

Recruiting

Address

Novartis Investigative Site

Halifax, Nova Scotia, B3H 1Z2

Novartis Investigative Site, Kentville, Nova Scotia, Canada

Status

Recruiting

Address

Novartis Investigative Site

Kentville, Nova Scotia, B4N 4K9

Novartis Investigative Site, Barrie, Ontario, Canada

Status

Recruiting

Address

Novartis Investigative Site

Barrie, Ontario, L4M 7G1

Novartis Investigative Site, Cobourg, Ontario, Canada

Status

Recruiting

Address

Novartis Investigative Site

Cobourg, Ontario, K9A 4J9

Novartis Investigative Site, Hamilton, Ontario, Canada

Status

Recruiting

Address

Novartis Investigative Site

Hamilton, Ontario, L8N 1V6

Novartis Investigative Site, Hamilton, Ontario, Canada

Status

Recruiting

Address

Novartis Investigative Site

Hamilton, Ontario, L8N 3Z5

Novartis Investigative Site, Hamilton, Ontario, Canada

Status

Recruiting

Address

Novartis Investigative Site

Hamilton, Ontario, L9B 1K5

Novartis Investigative Site, London, Ontario, Canada

Status

Recruiting

Address

Novartis Investigative Site

London, Ontario, N6A 3H7

Novartis Investigative Site, London, Ontario, Canada

Status

Recruiting

Address

Novartis Investigative Site

London, Ontario, N6H 5L5

Novartis Investigative Site, Markham, Ontario, Canada

Status

Recruiting

Address

Novartis Investigative Site

Markham, Ontario, L3P 1A8

Novartis Investigative Site, Mississauga, Ontario, Canada

Status

Recruiting

Address

Novartis Investigative Site

Mississauga, Ontario, L4W 0C2

Novartis Investigative Site, Mississauga, Ontario, Canada

Status

Recruiting

Address

Novartis Investigative Site

Mississauga, Ontario, L5H 1G9

Novartis Investigative Site, Nepean, Ontario, Canada

Status

Recruiting

Address

Novartis Investigative Site

Nepean, Ontario, K2G 6E2

Novartis Investigative Site, Newmarket, Ontario, Canada

Status

Recruiting

Address

Novartis Investigative Site

Newmarket, Ontario, L3Y 6P5

Novartis Investigative Site, North Bay, Ontario, Canada

Status

Recruiting

Address

Novartis Investigative Site

North Bay, Ontario, P1B 3Z7

Novartis Investigative Site, Ottawa, Ontario, Canada

Status

Recruiting

Address

Novartis Investigative Site

Ottawa, Ontario, K1Y 4E9

Novartis Investigative Site, Peterborough, Ontario, Canada

Status

Recruiting

Address

Novartis Investigative Site

Peterborough, Ontario, K9J 5K2

Novartis Investigative Site, Richmond Hill, Ontario, Canada

Status

Recruiting

Address

Novartis Investigative Site

Richmond Hill, Ontario, L4C 9M7

Novartis Investigative Site, Stoney Creek, Ontario, Canada

Status

Recruiting

Address

Novartis Investigative Site

Stoney Creek, Ontario, L8G 1H1

Novartis Investigative Site, Sudbury, Ontario, Canada

Status

Recruiting

Address

Novartis Investigative Site

Sudbury, Ontario, P3C 1X8

Novartis Investigative Site, Toronto, Ontario, Canada

Status

Recruiting

Address

Novartis Investigative Site

Toronto, Ontario, M2M 4J5

Novartis Investigative Site, Toronto, Ontario, Canada

Status

Recruiting

Address

Novartis Investigative Site

Toronto, Ontario, M3H 5Y8

Novartis Investigative Site, Toronto, Ontario, Canada

Status

Recruiting

Address

Novartis Investigative Site

Toronto, Ontario, M4W 2N2

Novartis Investigative Site, Waterloo, Ontario, Canada

Status

Recruiting

Address

Novartis Investigative Site

Waterloo, Ontario, N1H 1B1

Novartis Investigative Site, Waterloo, Ontario, Canada

Status

Recruiting

Address

Novartis Investigative Site

Waterloo, Ontario, N2J 1C4

Novartis Investigative Site, Laval, Quebec, Canada

Status

Recruiting

Address

Novartis Investigative Site

Laval, Quebec, H7N 6L2

Novartis Investigative Site, Montreal, Quebec, Canada

Status

Recruiting

Address

Novartis Investigative Site

Montreal, Quebec, H1A 1B9

Novartis Investigative Site, Montreal, Quebec, Canada

Status

Recruiting

Address

Novartis Investigative Site

Montreal, Quebec, H3B 3C3

Novartis Investigative Site, Montreal, Quebec, Canada

Status

Recruiting

Address

Novartis Investigative Site

Montreal, Quebec, H3H 1V4

Novartis Investigative Site, Saint Jerome, Quebec, Canada

Status

Recruiting

Address

Novartis Investigative Site

Saint Jerome, Quebec, J7Z 3B8

Novartis Investigative Site, Sainte-Hyacinthe, Quebec, Canada

Status

Recruiting

Address

Novartis Investigative Site

Sainte-Hyacinthe, Quebec, J2S 66

Novartis Investigative Site, Verdun, Quebec, Canada

Status

Recruiting

Address

Novartis Investigative Site

Verdun, Quebec, H4G 3E7

Novartis Investigative Site, Saskatoon, Saskatchewan, Canada

Status

Completed

Address

Novartis Investigative Site

Saskatoon, Saskatchewan, S7K O6O

Novartis Investigative Site, San José, San Jose, Costa Rica, Costa Rica

Status

Recruiting

Address

Novartis Investigative Site

San José, San Jose, Costa Rica,

Novartis Investigative Site, Santiago De Los Caballeros, Dominican Republic

Status

Recruiting

Address

Novartis Investigative Site

Santiago De Los Caballeros, , 51000

Novartis Investigative Site, Santo Domingo, Dominican Republic

Status

Recruiting

Address

Novartis Investigative Site

Santo Domingo, , 10103

Novartis Investigative Site, Guatemala City, Ciudad DE Guatemala, Guatemala

Status

Recruiting

Address

Novartis Investigative Site

Guatemala City, Ciudad DE Guatemala, 01010

Novartis Investigative Site, Guatemala City, Guatemala

Status

Recruiting

Address

Novartis Investigative Site

Guatemala City, , 01011

Novartis Investigative Site, Mexicali, Baja California, Mexico

Status

Recruiting

Address

Novartis Investigative Site

Mexicali, Baja California, 21100

Novartis Investigative Site, Tijuana, Baja California, Mexico

Status

Recruiting

Address

Novartis Investigative Site

Tijuana, Baja California, 22010

Novartis Investigative Site, Del Tlalpan, Ciudad De Mexico, Mexico

Status

Recruiting

Address

Novartis Investigative Site

Del Tlalpan, Ciudad De Mexico, 14389

Novartis Investigative Site, Toluca, Estado De Mexico, Mexico

Status

Recruiting

Address

Novartis Investigative Site

Toluca, Estado De Mexico, 50120

Novartis Investigative Site, Guadalajara, Jalisco, Mexico

Status

Recruiting

Address

Novartis Investigative Site

Guadalajara, Jalisco, 44636

Novartis Investigative Site, Monterrey, Nuevo Leon, Mexico

Status

Withdrawn

Address

Novartis Investigative Site

Monterrey, Nuevo Leon, 64710

Novartis Investigative Site, San Pedro Garza Garcia, Nuevo Leon, Mexico

Status

Recruiting

Address

Novartis Investigative Site

San Pedro Garza Garcia, Nuevo Leon, 66220

Novartis Investigative Site, Monterrey, Nuevo León, Mexico

Status

Recruiting

Address

Novartis Investigative Site

Monterrey, Nuevo León, 64460

Novartis Investigative Site, Aguascalientes, Mexico

Status

Recruiting

Address

Novartis Investigative Site

Aguascalientes, , 20127

Novartis Investigative Site, Guadalajara Jalisco, Mexico

Status

Recruiting

Address

Novartis Investigative Site

Guadalajara Jalisco, , 44610

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