An Observational Study of the Real Life Management of the Psoriasis Patients Treated With Enbrel According to the New Reimbursement Criteria (BEFLEX)
This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01557283
First received: September 30, 2011
Last updated: May 14, 2013
Last verified: May 2013
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Plaque Psoriasis Patients |
Other: Enbrel treatment |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Average treatment duration of patients with Enbrel expressed as a number of weeks/year. [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of patients who receive continuous treatment [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]
- Number of patients who receive intermittent treatment [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]
- Number of weeks off treatment [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
Detailed Description:
100 patients will be followed for at least 1 year
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| 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.
Criteria
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01557283 History of Changes |
| Other Study ID Numbers: | B1801314, BEFLEX |
| Study First Received: | September 30, 2011 |
| Last Updated: | May 14, 2013 |
| Health Authority: | Belgium: Institutional Review Board |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases TNFR-Fc fusion protein Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gastrointestinal Agents Immunologic Factors Immunosuppressive Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013