An Observational Study of the Real Life Management of the Psoriasis Patients Treated With Enbrel According to the New Reimbursement Criteria

NCT01557283 | Completed Results

• 2 other identifiers: B1801314BEFLEX
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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

Conditions

Plaque Psoriasis Patients

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (4)

• Number of Weeks of Off-Treatment

  Baseline up to end of study (90 weeks)

• Psoriasis Area and Severity Index (PASI) Score

  Start and end of cycle 1, 2, 3

• Percentage of Body Surface Area (BSA) Affected by Psoriasis

  Start and end of cycle 1, 2, 3

• Number of Participants With Reasons for Treatmant Discontinuation

  Baseline up to end of study (90 weeks)

Other Outcomes (2)

• Number of Participants Who Received Continuous Treatment

  Baseline up to end of study (90 weeks)

• Number of Participants Who Received Intermittent Treatment

  Baseline up to end of study (90 weeks)

Study Arms (1)

Plaque psoriasis patients

Plaque psoriasis patients treated with Enbrel after the approval of the new belgian reimbursement criteria

Other: Enbrel treatment

Interventions

Enbrel treatment OTHER

Enbrel SC 50mg once weekly or 25mg twice weekly

Plaque psoriasis patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• N/A

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Herestraat 49

Leuven, 3000, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2011
• First Posted: March 19, 2012
• Study Start: September 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 30, 2014
• Results First Posted: June 30, 2014

Record last verified: 2014-05

Locations

BE (1)