An Observational Study of the Real Life Management of the Psoriasis Patients Treated With Enbrel According to the New Reimbursement Criteria
NCT01557283
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Adult Trials: 18+ Years
- 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.
N/A
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | An Observational Study of the Real Life Management of the Psoriasis Patients Treated With Enbrel According to the New Reimbursement Criteria | |||
| 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 | |||
| Brief 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 off treatment | |||
| Detailed Description | 100 patients will be followed for at least 1 year | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Cohort Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| 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. | |||
| Condition | Plaque Psoriasis Patients | |||
| Intervention | Other: Enbrel treatment
Enbrel SC 50mg once weekly or 25mg twice weekly | |||
| Study Groups/Cohorts | Plaque psoriasis patients
Plaque psoriasis patients treated with Enbrel after the approval of the new belgian reimbursement criteria Intervention: Other: Enbrel treatment | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status | Completed | |||
| Actual Enrollment | 140 | |||
| Original Estimated Enrollment | 100 | |||
| Actual Study Completion Date | June 2013 | |||
| Actual Primary Completion Date | June 2013 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria: N/A | |||
| Sex/Gender |
| |||
| Ages | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Belgium | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT01557283 | |||
| Other Study ID Numbers | B1801314 BEFLEX | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | May 2014 | |||