Long-Term, Prospective, Observational Cohort Study of Safety and Effectiveness of Pediatric Psoriasis Patients Treated With Etanercept in a Naturalistic Setting: A Post-Authorization Safety Study (PASS)
Phase 4
4 Years
17 Years
4 Years
17 Years
Open (Enrolling)
Both
Psoriasis
Both
Psoriasis
Trial Information
Long-Term, Prospective, Observational Cohort Study of Safety and Effectiveness of Pediatric Psoriasis Patients Treated With Etanercept in a Naturalistic Setting: A Post-Authorization Safety Study (PASS)
Non-probability sample
Inclusion Criteria:
- 17 years of age or younger
- Diagnosed with plaque psoriasis by a dermatologist.
- Prior to enrollment, there must be a clinical decision to initiate etanercept for the
treatment of plaque psoriasis and etanercept must then be initiated.
- Actively being treated with etanercept, regardless of length of treatment prior to
enrollment
- Willing to provide written informed consent
Exclusion Criteria:
- Prior therapy with etanercept or other biologic agent
- History of malignancy
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Number of SAEs including serious infections and malignancy
Outcome Time Frame:
Five year follow-up. Follow-up every 3 months for the first 2 years and 6 monthly for the next 3 yr
Safety Issue:
Yes
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
0881X1-4654
NCT ID:
NCT01100034
Start Date:
November 2010
Completion Date:
June 2018
Related Keywords:
- Psoriasis
- pediatric psoriasis
- etanercept
- PASS
- safety
- effectiveness
- Psoriasis
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