Herestraat 49
Leuven, 3000, Belgium
NCT Number: NCT01557283
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
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Leuven, 3000, Belgium
100 patients will be followed for at least 1 year
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
N/A
Enbrel SC 50mg once weekly or 25mg twice weekly
Time frame: Baseline up to end of study (90 weeks)
Average duration of time in weeks for treatment with etanercept was reported.
Time frame: Baseline up to end of study (90 weeks)
Total duration of time in weeks for which participants discontinued etanercept treatment was reported.
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.
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.
Time frame: Baseline up to end of study (90 weeks)
Number of participants who discontinued etanercept before completing the study was reported.
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.
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.
Pfizer
Industry
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
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.
Published trials that share one or more normalized conditions with this study.
NCT06842199
Plaque Psoriasis Patients
Hefei, Anhui, China
View Trial Details