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

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

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

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis Patients
• Intervention / Treatment: Other: Enbrel treatment

Detailed Description

100 patients will be followed for at least 1 year

• Study Type: Observational
• Enrollment (Actual): 140

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Herestraat 49

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All subjects enrolled should meet the usual prescribing criteria for Enbrel as per local reimbursement criteria and should be entered into the study at the investigator's discretion. It is requested to include patients in a consecutive manner as much as possible.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Weeks of Off-Treatment	Total duration of time in weeks for which participants discontinued etanercept treatment was reported.	Baseline up to end of study (90 weeks)
Psoriasis Area and Severity Index (PASI) Score	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.	Start and end of cycle 1, 2, 3
Percentage of Body Surface Area (BSA) Affected by Psoriasis	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.	Start and end of cycle 1, 2, 3
Number of Participants With Reasons for Treatmant Discontinuation	Number of participants who discontinued etanercept before completing the study was reported.	Baseline up to end of study (90 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Received Continuous Treatment	Number of participants who were treated continuously with etanercept without any treatment discontinuation as per dermatologist's discretion was reported.	Baseline up to end of study (90 weeks)
Number of Participants Who Received Intermittent Treatment	Number of participants who received etanercept treatment in cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation was reported.	Baseline up to end of study (90 weeks)

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: September 30, 2011
• First Submitted That Met QC Criteria: March 15, 2012
• First Posted (Estimate): March 19, 2012

Study Record Updates

• Last Update Posted (Estimate): June 30, 2014
• Last Update Submitted That Met QC Criteria: May 28, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Etanercept
• Other Study ID Numbers: B1801314; BEFLEX