Clinical trial NCT00322439: Observational Safety Study of Etanercept (Enbrel) for Treatment of Psoriasis
Official title: Observational Post-Marketing Safety Surveillance Registry of Enbrel (Etanercept) for Treatment of Psoriasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: plaque Psoriasis patients
TNF-inhibitor naïve
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2006-05-08
Enrollment: 2511
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with plaque psoriasis, who are currently receiving Enbrel or who are intending to start or restart Enbrel therapy at multi-centers.

Brief summary: This is an observational safety study tracking psoriasis patients on etanercept (Enbrel) for 5 years.

Detailed description: This is a prospective, multi-center, observational surveillance registry to evaluate data on the long-term safety of etanercept (Enbrel) use in the treatment of psoriasis.

Eligibility criteria: Inclusion Criteria:

* Patients with plaque psoriasis

Exclusion Criteria:

* Prior exposure to any tumor necrosis factor (TNF)-inhibitor
* Patients for whom Enbrel is contraindicated
* Patients currently enrolled in or has not yet completed at least 30 days since ending other investigational drug study.

Primary outcomes:
measure: Five-year Cumulative Incidence of Serious Adverse Events and Serious Infectious Events
timeFrame: 5 years
Secondary outcomes:
measure: Five-year Cumulative Incidence for Events of Medical Interest (EMIs)
timeFrame: 5 years
measure: Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear)
timeFrame: Baseline and at 3 and 5 years
measure: Percentage of Participants With a Patient's Global Assessment of Psoriasis Score of 0 or 1
timeFrame: Baseline and at 3 and 5 years
measure: Percentage of Participants With a Dermatology Life Quality Index (DLQI) Response
timeFrame: Baseline, Year 3 and Year 5
measure: Euroqol-5D (EQ-5D) Total Score
timeFrame: Baseline, Year 3 and Year 5
measure: Euroqol-5D (EQ-5D) Visual Analog Scale (VAS)
timeFrame: Baseline, Year 3 and Year 5
measure: Healthcare Resource Use
timeFrame: Baseline, Year 3 and Year 5
measure: Work Productivity and Activity Impairment (WPAI)
timeFrame: Baseline, Year 3 and Year 5
measure: Percentage of Body Surface Area Affected by Psoriasis
timeFrame: Baseline, Year 3 and Year 5
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Kimball AB, Pariser D, Yamauchi PS, Menter A, Teller CF, Shi Y, Creamer K, McCroskery P, Kricorian G, Gelfand JM. OBSERVE-5, an Observational Post-Marketing SafetySurveillance Registry of Etanercept for the treatment of Psoriasis: A Model for Studying New Psoriasis Therapies. Psoriasis Forum. 2010;16(3):3-7.
citation: Kimball AB, Pariser D, Yamauchi PS, Menter A, Teller CF, Shi Y, Yong M, Creamer K, Hooper M, Aras G, Kricorian G, Gelfand JM. OBSERVE-5 interim analysis: an observational postmarketing safety registry of etanercept for the treatment of psoriasis. J Am Acad Dermatol. 2013 May;68(5):756-64. doi: 10.1016/j.jaad.2012.10.055. Epub 2013 Jan 26.
citation: Kimball AB, Rothman KJ, Kricorian G, Pariser D, Yamauchi PS, Menter A, Teller CF, Aras G, Accortt NA, Hooper M, Rice KC, Gelfand JM. OBSERVE-5: observational postmarketing safety surveillance registry of etanercept for the treatment of psoriasis final 5-year results. J Am Acad Dermatol. 2015 Jan;72(1):115-22. doi: 10.1016/j.jaad.2014.08.050. Epub 2014 Sep 26.
citation: Kimball AB, Schenfeld J, Accortt NA, Anthony MS, Rothman KJ, Pariser D. Incidence rates of malignancies and hospitalized infectious events in patients with psoriasis with or without treatment and a general population in the U.S.A.: 2005-09. Br J Dermatol. 2014 Feb;170(2):366-73. doi: 10.1111/bjd.12744.