An Observational Study of the Real Life Management of the Psoriasis Patients Treated With Enbrel According to the New Reimbursement Criteria (BEFLEX)
|ClinicalTrials.gov Identifier: NCT01557283|
Recruitment Status : Completed
First Posted : March 19, 2012
Results First Posted : June 30, 2014
Last Update Posted : June 30, 2014
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
|Condition or disease||Intervention/treatment|
|Plaque Psoriasis Patients||Other: Enbrel treatment|
|Study Type :||Observational|
|Actual Enrollment :||140 participants|
|Official Title:||An Observational Study of the Real Life Management of the Psoriasis Patients Treated With Enbrel According to the New Reimbursement Criteria - Beflex Study|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
Plaque psoriasis patients
Plaque psoriasis patients treated with Enbrel after the approval of the new belgian reimbursement criteria
Other: Enbrel treatment
Enbrel SC 50mg once weekly or 25mg twice weekly
- Number of Weeks of Etanercept Treatment [ Time Frame: Baseline up to end of study (90 weeks) ]Average duration of time in weeks for treatment with etanercept was reported.
- Number of Weeks of Off-Treatment [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline up to end of study (90 weeks) ]Number of participants who discontinued etanercept before completing the study was reported.
- Number of Participants Who Received Continuous Treatment [ Time Frame: Baseline up to end of study (90 weeks) ]Number of participants who were treated continuously with etanercept without any treatment discontinuation as per dermatologist's discretion was reported.
- Number of Participants Who Received Intermittent Treatment [ Time Frame: Baseline up to end of study (90 weeks) ]Number of participants who received etanercept treatment in cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation was reported.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01557283
|Leuven, Belgium, 3000|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|