A Registry of Patients With Moderate to Severe Plaque Psoriasis

Active, not recruiting

• Conditions: Psoriasis
• Interventions: Drug: Secikinumab

• Registration Number: NCT02786186
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-12-23
• Study First Submitted: 2016-05-06
• Study First Submitted QC: 2016-05-25
• Study First Posted: 2016-05-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-22
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2384

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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: 1. The proportion of patients that experience at least one event; and; 2. The number of events per participant

Secondary Outcome Measures

Name	Time	Method
Mean change for Work Productivity and Activity Impairment (WPAI) score	Change from Baseline through month 60
Mean change for Hospital Anxiety and Depression Scale (HADS) score	Change from Baseline through month 60
Mean change for Dermatology Life Quality Index (DLQI) score	Change from Baseline through month 60
Mean change for Psoriasis Symptom Diary (PSD) score	Change from Baseline through month 60
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)
Mean change for Psoriasis Epidemiology Screening Tool (PEST) score	Change from Baseline through month 60
Mean change for direct and indirect cost associated to Psoriasis	Change from Baseline through month 60
Mean change for Treatment Satisfaction Scale (TSS) score	Change from Baseline through month 60

Trial Locations

Locations (1)

Novartis Investigative Site; 🇵🇦 Panama, Panama