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

Novartis

Status: Active, not recruiting

Conditions: Psoriasis

Treatments: Drug: Secikinumab

Study type: Observational

Funder types: Industry

Identifiers

NCT02786186

CAIN457ACA02

Details and patient eligibility

About

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.

Full 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).

Enrollment: 2,384 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

2,384 participants in 2 patient groups

Secikinumab

Description:

Patients treated with secukinumab

Treatment:

Drug: Secikinumab

Approved standard of care

Description:

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

Treatment:

Drug: Secikinumab