Plaque Psoriasis Patients Clinical Trial
— BEFLEXOfficial title:
An Observational Study of the Real Life Management of the Psoriasis Patients Treated With Enbrel According to the New Reimbursement Criteria - Beflex Study
| Verified date | May 2014 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Belgium: Institutional Review Board |
| Study type | Observational |
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
| Status | Completed |
| Enrollment | 140 |
| Est. completion date | June 2013 |
| Est. primary completion date | June 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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: |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Herestraat 49 | Leuven |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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) | No |
| Other | 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) | No |
| Primary | 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) | No |
| Secondary | 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) | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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) | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT06299982 -
An Phase III Study of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Participants With PsO
|
Phase 3 |