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OpenTrials
Completed

NCT Number: NCT01557283

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Herestraat 49

Leuven, 3000, Belgium

About this study

100 patients will be followed for at least 1 year

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enbrel treatment

Other

Enbrel SC 50mg once weekly or 25mg twice weekly

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Acronym: BEFLEX

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 19, 2012
Registry last updated
Jun 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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