An Observational Study of the Real Life Management of the Psoriasis Patients Treated With Enbrel According to the New Reimbursement Criteria

Completed

• Conditions: Plaque Psoriasis Patients
• Interventions: Other: Enbrel treatment

• Registration Number: NCT01557283
• Lead Sponsor: Pfizer

Brief Summary

With the new reimbursement criteria, we want:

To describe the average treatment duration of patients with Enbrel expressed as a number of weeks/year.

To describe the number of patients who receive continuous treatment To describe the number of patients who receive intermittent treatment To describe the number of weeks off treatment

Detailed Description

100 patients will be followed for at least 1 year

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-30
• Study First Submitted QC: 2012-03-15
• Study First Posted: 2012-03-19
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-05
• Results First Submitted: 2014-05-28
• Results First Submitted QC: 2014-05-28
• Last Update Submitted: 2014-05-28
• Results First Posted: 2014-06-30
• Last Update Posted: 2014-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Patient restarts or is starting treatment with Enbrel for his/her psoriasis in alignment with reimbursement criteria
• Patients ≥18 year
• Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria

N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Plaque psoriasis patients	Enbrel treatment	Plaque psoriasis patients treated with Enbrel after the approval of the new belgian reimbursement criteria

Primary Outcome Measures

Name	Time	Method
Number of Weeks of Etanercept Treatment	Baseline up to end of study (90 weeks)	Average duration of time in weeks for treatment with etanercept was reported.

Secondary Outcome Measures

Name	Time	Method
Number of Weeks of Off-Treatment	Baseline up to end of study (90 weeks)	Total duration of time in weeks for which participants discontinued etanercept treatment was reported.
Psoriasis Area and Severity Index (PASI) Score	Start and end of cycle 1, 2, 3	Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, and legs. For each section, percent (%) area of skin involved was estimated: 0 = 0%, 1 = less than (\<) 10%, 2 = 10 to \<30%, 3 = 30 to \<50%, 4 = 50 to \<70%, 5= 70 to \<90%, 6 = 90 to 100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0 = none to 4 = maximum. Final PASI = sum of severity parameters for each section\*area score\*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease.
Percentage of Body Surface Area (BSA) Affected by Psoriasis	Start and end of cycle 1, 2, 3	Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb = 1 percent (%) of total BSA. Regions of the body were assigned specific number of palms with percentage \[Head and neck = 10% (10 palms), upper extremities = 20% (20 palms), Trunk (axillae and groin) = 30% (30 palms), lower extremities (buttocks) = 40% (40 palms)\]. The total BSA affected was the summation of individual regions affected.
Number of Participants With Reasons for Treatmant Discontinuation	Baseline up to end of study (90 weeks)	Number of participants who discontinued etanercept before completing the study was reported.

Trial Locations

Locations (1)

Herestraat 49; 🇧🇪 Leuven, Belgium