Clinical trial NCT00708708: Observational Study Evaluating Etanercept (Enbrel®) In Subjects With Plaque-Type Psoriasis In Usual Care Settings
Official title: A Prospective Non-interventional Study (Nis) Of The Routine Use Of Etanercept In The Long-term Treatment Of Patients With Plaque-type Psoriasis In Everyday Practice: An Efficacy, Safety, And Health Economic Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: Plaque-type psoriasis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-07-02
Enrollment: 926
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with moderate to severe plaque psoriasis

Brief summary: This prospective observational cohort study will assess the average duration of the drug free interval between etanercept treatment cycles in usual care settings in Germany.

Detailed description: Non-interventional study: subjects to be selected according to the usual clinical practice of their physician

Eligibility criteria: Inclusion Criteria:

* Subjects with moderate to severe plaque psoriasis on etanercept treatment according to the Summary of Product Characteristics (SmPC), and applicable local guidelines
* Subjects for whom the decision has already been made to initiate treatment with etanercept

Exclusion Criteria:

* Sepsis or risk of sepsis
* Current or recent infections, including chronic or localized, e.g. tuberculosis (TB) infection
* Vaccination with live vaccine in last 4 weeks, or expected to require such vaccination during the course of the study
* Pre-existing or recent onset CNS demyelinating disease.
* Class III or IV congestive heart failure as defined by the New York Heart Association classification or uncompensated congestive heart failure.
* Previous or ongoing treatment with etanercept
* Participation in other clinical or observational studies.
* Patients with psoriatic arthritis requiring continuous etanercept treatment.

Primary outcomes:
measure: Duration of Drug-Free Interval Prior to Treatment Cycle 2
timeFrame: Cycle 1 Week 24 up to Cycle 2 Week 0
measure: Duration of Drug-Free Interval Prior to Treatment Cycle 3
timeFrame: Cycle 2 Week 24 up to Cycle 3 Week 0
measure: Duration of Drug-Free Interval Prior to Treatment Cycle 4
timeFrame: Cycle 3 Week 24 up to Cycle 4 Week 0
measure: Duration of Drug-Free Interval Prior to Treatment Cycle 5
timeFrame: Cycle 4 Week 24 up to Cycle 5 Week 0
measure: Duration of Drug-Free Interval Prior to Treatment Cycle 6
timeFrame: Cycle 5 Week 24 up to Cycle 6 Week 0
Secondary outcomes:
measure: Psoriasis Area and Severity Index (PASI) Score
timeFrame: Week 0, 12, 24 of Cycle 1 to 6
measure: Percentage of Body Surface Area (BSA) Affected by Psoriasis
timeFrame: Week 0, 12, 24 of Cycle 1 to 6
measure: Static Physician Global Assessment (sPGA) of Disease Activity
timeFrame: Week 0, 12, 24 of Cycle 1 to 6
measure: Physician Global Assessment of Efficacy
timeFrame: Week 24 of Cycle 1 to 6
measure: Patient Global Assessment of Efficacy
timeFrame: Week 24 of Cycle 1 to 6
measure: Number of Injections Per Year
timeFrame: Year 1, 2, 3, 4, 5
measure: Cumulative Dose of Etanercept Per Year
timeFrame: Year 1, 2, 3, 4, 5
measure: Percentage of Time on Treatment in First Year
timeFrame: Year 1
measure: Percentage of Time on Treatment Over Entire Period
timeFrame: Cycle 1 up to Cycle 6
measure: Patient's Global Assessment of Disease Activity (PatGA)
timeFrame: Week 0, 12, 24 of Cycle 1 to 6
measure: Dermatology Life Quality Index (DLQI) Score
timeFrame: Week 0, 12, 24 of Cycle 1 to 6
measure: Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)
timeFrame: Week 0, 12, 24 of Cycle 1 to 6
measure: Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)
timeFrame: Week 0, 12, 24 of Cycle 1 to 6
measure: Number of Participants With at Least 1 Concomitant Medication
timeFrame: Cycle 1 Week 0 up to Cycle 6 Week 24
measure: Annual Costs for Treatment With Etanercept
timeFrame: Year 1, 2, 3, 4, 5
measure: Average Cost of Treatment by Disease Severity
timeFrame: Year 1, 2, 3, 4, 5
measure: Amount of Annual Cost for Participants Arising From Out-of-Pocket Payment and Concomitant Medications
timeFrame: Prior to study, Year 1, 2, 3, 4, 5
measure: Effect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)
timeFrame: Week 0, 12, 24 of Cycle 1 to 6
measure: Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score
timeFrame: Week 0, 12, 24 of Cycle 1 to 6
measure: Effect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)
timeFrame: Week 0, 12, 24 of Cycle 1 to 6
measure: Participant Perception of Drug-Free Interval: Length of Drug-Free Interval
timeFrame: Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5
measure: Participant Perception of Drug-Free Interval: Reason for Returning to Practice
timeFrame: Before Cycle 2, 3, 4, 5, 6
measure: Participant Perception of Drug-Free Interval: Liking of Drug-Free Interval
timeFrame: Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5
measure: Participant Perception of Drug-Free Interval: Duration
timeFrame: Before Cycle 2, 3, 4, 5, 6
measure: Participant Perception of Drug-Free Interval: Relapse of Symptoms
timeFrame: Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5
measure: Participant Perception of Drug-Free Interval: Effective Therapy After Drug-Free Interval
timeFrame: Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5
measure: Participant Perception of Drug-Free Interval: Disease Activity
timeFrame: Before Cycle 2, 3, 4, 5, 6
measure: Participant Perception of Drug-Free Interval: Satisfaction With Skin Condition
timeFrame: Before Cycle 2, 3, 4, 5, 6
measure: Participant Perception of Drug-Free Interval: Risk for Adverse Drug Reactions
timeFrame: Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5
measure: Participant Perception of Drug-Free Interval: Reminder of Disease
timeFrame: Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5
measure: Participant Perception of Drug-Free Interval: Comfort in Everyday Life
timeFrame: Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5
measure: Participant Perception of Drug-Free Interval: Preference to Continuous Therapy
timeFrame: Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5
measure: Participant Perception of Drug-Free Interval: Recommendation of Therapy
timeFrame: Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5
measure: Criteria for Treatment Resumption
timeFrame: Before Cycle 2, 3, 4, 5, 6
measure: Number of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs)
timeFrame: Cycle 1 Week 0 up to 30 days after end of study (where end of study was Cycle 6 Week 24)
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: Westfaelische Wilhelms-Universitaet Muenster, Zentr. f. Derm
state: NRW
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Luger T, Schopf RE, Schwanke A, Langhammer S, Meng T, Loschmann PA. An observational study to evaluate the long-term outcomes of treatment with etanercept in patients with plaque-type psoriasis. J Eur Acad Dermatol Venereol. 2016 Oct;30(10):1730-1741. doi: 10.1111/jdv.13673. Epub 2016 Jun 14.