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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 926
- Locations
- 1
- Primary Endpoint
- Duration of Drug-Free Interval Prior to Treatment Cycle 2
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
A
Patients with moderate to severe plaque psoriasis
Intervention: etanercept (Enbrel®) (Drug)
Outcomes
Primary Outcomes
Duration of Drug-Free Interval Prior to Treatment Cycle 2
Time Frame: Cycle 1 Week 24 up to Cycle 2 Week 0
Average duration of participant's drug-free interval between the end of treatment Cycle 1 and Cycle 2 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.
Duration of Drug-Free Interval Prior to Treatment Cycle 5
Time Frame: Cycle 4 Week 24 up to Cycle 5 Week 0
Average duration of participant's drug-free interval between the end of treatment Cycle 4 and Cycle 5 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.
Duration of Drug-Free Interval Prior to Treatment Cycle 6
Time Frame: Cycle 5 Week 24 up to Cycle 6 Week 0
Average duration of participant's drug-free interval between the end of treatment Cycle 5 and Cycle 6 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.
Duration of Drug-Free Interval Prior to Treatment Cycle 3
Time Frame: Cycle 2 Week 24 up to Cycle 3 Week 0
Average duration of participant's drug-free interval between the end of treatment Cycle 2 and Cycle 3 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.
Duration of Drug-Free Interval Prior to Treatment Cycle 4
Time Frame: Cycle 3 Week 24 up to Cycle 4 Week 0
Average duration of participant's drug-free interval between the end of treatment Cycle 3 and Cycle 4 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.
Secondary Outcomes
- Psoriasis Area and Severity Index (PASI) Score(Week 0, 12, 24 of Cycle 1 to 6)
- Percentage of Body Surface Area (BSA) Affected by Psoriasis(Week 0, 12, 24 of Cycle 1 to 6)
- Static Physician Global Assessment (sPGA) of Disease Activity(Week 0, 12, 24 of Cycle 1 to 6)
- Physician Global Assessment of Efficacy(Week 24 of Cycle 1 to 6)
- Patient Global Assessment of Efficacy(Week 24 of Cycle 1 to 6)
- Number of Injections Per Year(Year 1, 2, 3, 4, 5)
- Cumulative Dose of Etanercept Per Year(Year 1, 2, 3, 4, 5)
- Percentage of Time on Treatment in First Year(Year 1)
- Percentage of Time on Treatment Over Entire Period(Cycle 1 up to Cycle 6)
- Patient's Global Assessment of Disease Activity (PatGA)(Week 0, 12, 24 of Cycle 1 to 6)
- Dermatology Life Quality Index (DLQI) Score(Week 0, 12, 24 of Cycle 1 to 6)
- Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)(Week 0, 12, 24 of Cycle 1 to 6)
- Number of Participants With at Least 1 Concomitant Medication(Cycle 1 Week 0 up to Cycle 6 Week 24)
- Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)(Week 0, 12, 24 of Cycle 1 to 6)
- Annual Costs for Treatment With Etanercept(Year 1, 2, 3, 4, 5)
- Average Cost of Treatment by Disease Severity(Year 1, 2, 3, 4, 5)
- Amount of Annual Cost for Participants Arising From Out-of-Pocket Payment and Concomitant Medications(Prior to study, Year 1, 2, 3, 4, 5)
- Effect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)(Week 0, 12, 24 of Cycle 1 to 6)
- Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score(Week 0, 12, 24 of Cycle 1 to 6)
- Effect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)(Week 0, 12, 24 of Cycle 1 to 6)
- Participant Perception of Drug-Free Interval: Length of Drug-Free Interval(Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5)
- Participant Perception of Drug-Free Interval: Reason for Returning to Practice(Before Cycle 2, 3, 4, 5, 6)
- Participant Perception of Drug-Free Interval: Liking of Drug-Free Interval(Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5)
- Participant Perception of Drug-Free Interval: Duration(Before Cycle 2, 3, 4, 5, 6)
- Participant Perception of Drug-Free Interval: Relapse of Symptoms(Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5)
- Participant Perception of Drug-Free Interval: Effective Therapy After Drug-Free Interval(Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5)
- Participant Perception of Drug-Free Interval: Disease Activity(Before Cycle 2, 3, 4, 5, 6)
- Participant Perception of Drug-Free Interval: Satisfaction With Skin Condition(Before Cycle 2, 3, 4, 5, 6)
- Participant Perception of Drug-Free Interval: Risk for Adverse Drug Reactions(Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5)
- Participant Perception of Drug-Free Interval: Reminder of Disease(Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5)
- Participant Perception of Drug-Free Interval: Comfort in Everyday Life(Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5)
- Participant Perception of Drug-Free Interval: Preference to Continuous Therapy(Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5)
- Participant Perception of Drug-Free Interval: Recommendation of Therapy(Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5)
- Criteria for Treatment Resumption(Before Cycle 2, 3, 4, 5, 6)
- Number of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs)(Cycle 1 Week 0 up to 30 days after end of study (where end of study was Cycle 6 Week 24))