Plaque Psoriasis PatientsBEFLEXNCT01557283
An Observational Study of the Real Life Management of the Psoriasis Patients Treated With Enbrel According to the New Reimbursement Criteria
An observational study of Plaque Psoriasis Patients, run by Pfizer at 1 site in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis Patients
- What is being tested?
- Enbrel treatment
- How many people
- 140 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2011to Jun 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the detailed description
100 patients will be followed for at least 1 year
- Conditions
- Plaque Psoriasis Patients
- Being tested
- Enbrel treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enbrel treatmentOther
Enbrel SC 50mg once weekly or 25mg twice weekly
| Study group | Role | What they receive |
|---|---|---|
| Plaque psoriasis patients | Plaque psoriasis patients treated with Enbrel after the approval of the new belgian reimbursement criteria Receives: Other: Enbrel treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Weeks of Etanercept Treatment
Average duration of time in weeks for treatment with etanercept was reported.
Measured: Baseline up to end of study (90 weeks)
Secondary outcomes (4)
Number of Weeks of Off-Treatment
Total duration of time in weeks for which participants discontinued etanercept treatment was reported.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline up to end of study (90 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2012 (estimated)
- Study startSep 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Plaque Psoriasis PatientsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557283
- Sponsor's protocol ID
- B1801314
- Other IDs
- BEFLEX
- Acronym
- BEFLEX
- Status last verified
- May 2014
- First submitted
- 30 Sep 2011
- Last updated
- 30 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01557283
- Acronym / sponsor ID
- BEFLEX / B1801314
- Conditions
- Plaque Psoriasis Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 19 Mar 2012 (estimated)
- Results
- Posted 30 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
100 patients will be followed for at least 1 year
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Plaque psoriasis patients | – | Other: Enbrel treatmentPlaque psoriasis patients treated with Enbrel after the approval of the new belgian reimbursement criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enbrel treatmentEnbrel SC 50mg once weekly or 25mg twice weekly | Other | Plaque psoriasis patients |
Primary outcome
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.
4 secondary outcomes
Number of Weeks of Off-Treatment
Time frame: Baseline up to end of study (90 weeks)
Psoriasis Area and Severity Index (PASI) Score
Time frame: Start and end of cycle 1, 2, 3
Percentage of Body Surface Area (BSA) Affected by Psoriasis
Time frame: Start and end of cycle 1, 2, 3
Number of Participants With Reasons for Treatmant Discontinuation
Time frame: Baseline up to end of study (90 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plaque Psoriasis Patients, run by Pfizer at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Weeks of Etanercept Treatment (time frame: Baseline up to end of study (90 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2014.