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2015 Vivette Escueta enbrel pharmacoepidemiological study protocol - AAPS presentation
1. Reference: Public Document NCT #: NCT00322439
Sponsor: Amgen Canada Inc.
By: Vivette Escueta, RPh
Presented at AAPS, 2015
Research Director: Professor Peivand Pirouzi
2. I. Introduction
II. Study Objectives and
Endpoints
III. Study Design
IV. Study Population
V. Study Treatment and
Duration
VI. Study Procedures
VII. Data Analysis
VIII. Data Collection and
Management
IX. Adverse Event Reporting
X. Strengths and Limitations
XI. Quality Control and
Quality Assurance
XII. Ethics
XIII. Communication and
Publication of Study
XIV. References
3. ETANERCEPT
Medical Biologic Device
Amgen Canada
Enbrel
TNF Blocker
Indicated for Chronic
Moderate to Severe Plaque
Psoriasis
Relieve the symptoms of
autoimmune disorders
4. ETANERCEPT
Medical Biologic Device
Amgen Canada
Enbrel
TNF Blocker
Indicated for Chronic
Moderate to Severe Plaque
Psoriasis
Relieve the symptoms of
autoimmune disorders
First approved for RA
(USA, 1998)
Approval 2004 (US) and
2005 (Canada)
Administered SQ
Pre-filled syringe
Pre-filled autoinjector
Multiple-use Vial
5. The study is a long-term analysis of Safety
5 years observational and surveillance registry
2500 patients assessments across research sites in US
and CANADA
Needed to detect rare adverse events in a broader
patient population
Malignancies, Lymphomas, Nonmelanoma Skin Cancer
(NMSC)
6. To Assess the long-term safety and effectiveness of
Etanercept (Enbrel)
Determine incidence rates of SAE and SIE
Compare Rates of SAE, SIE and EMIs according to:
Prior exposure to systemic therapies or phototherapy
Exposure to Enbrel therapy
Presence of certain co-morbid disorders
Evaluate incidence rate of EMIs for participating subjects
Evaluate Effectiveness outcomes
7. Phase IV, Prospective, Multicenter, Observational,
Surveillance registry
Self-administered dose of etanercept
Evaluated at 6-months interval for 5 years.
8. Inclusion Criteria
Patients with Plaque
Psoriasis
On Enbrel therapy
Prior exposure to any TNF
Inhibitor
Patients for whom Enbrel
is contraindicated
Patients currently enrolled
in or has not yet completed
at least 30 days since
ending their
investigational drug study
Exclusion Criteria
9. Participants receive etanercept treatment at the dose
and regimen determined by the investigator
Evaluated every 6 months for 5 years
Participants may:
discontinue therapy
Switch to another anti-psoriatic therapies
Discontinue any or all treatments
10. 375 sites (37 Canada, 338 USA)
2500 Patients
Assessment of SAE, SIE and EMI throughout the study and 30 days
after.
SPGA at baseline, year 3 and year 5
DLQI at Baseline, Year 3 and Year 5
EQ-5D at baseline, Year 3 and Year 5
BSA at baseline Year 3 and Year 5
Incidence proportions for SAE, SIE and EMIs collected from a large US
administrative health claim database
Truven Health MarketScan Commercial Claims and Encounters and
MarketScan Medicare Supplemental Database
11. MarketScan collect enrollment data, medical claims and lab and
prescription data.
Criteria:
18 years or older and 90 years or younger
Between January 1, 2006 to December 31, 2006 (enrollment period)
12 months of continuous enrollment before their index date to
describe their medical and treatment history (baseline period)
Incidence rates calculated and age-and sex-standardized to the
study population for each outcome of interest at 95% confidence
intervals.
12. Descriptive Statistics for baseline characteristics and
outcome measures
Kaplan-Meier Methodology for primary analysis of
safety end points
Cumulative Incidences: 2 methods:
Include all time from first dose of etanercept to start
date of the first event occurrence
Excluding time intervals and corresponding events
when patient is not exposed
13. Adverse events will be collected from scheduled visits
Telephone reminders for visits
Retention packages
Reimbursements for each site for the effort to remind
patients
In case of patient transfers
Telephone calls
Telephone visits
14. Use of Large database
MarketScan registered 48,136 Psoriasis patients
Lack of internal comparator
Rare events may not be detected
15. The Sponsor will not have access to health register records
at the level of the individual patient
Investigators are responsible for following site standard
protocol to ensure data quality and integrity,
including archiving of statistical programs,
documentation of data cleaning
validity for created variables,
description of available data.
Records will be retained on each site however all copies of
the data and results will be made available to the sponsor.
16. In compliance with the Declaration of Helsinki
Follow Good Pharmacoepidemiology Practice, Good
Clinical Practice, Good Epidemiological Practice
Informed Consents and Protocol approval from IRB
All patients provided with IC prior
conducting/participating in study.
17. American Academy of Dermatology Work Group, Menter, A., Korman, N.J., Elmets, C.A.,
Feldman, S.R., Gelfand, J.M., Gordon, K.B. et al. Guidelines of care for the
management of psoriasis and psoriatic arthritis, section 6. Guidelines of care for
the treatment of psoriasis and psoriatic arthritis: case-based presentations and
evidence-based conclusions. J Am Acad Dermatol. 2011; 65: 137–174
Enbrel (etanercept) [full prescribing information]. Immunex Corp, Thousand Oaks,
CA; 2011
Kimball, A.B., Pariser, D., Yamauchi, P.S., Menter, A., Teller, C.F., Shi, Y. et al. OBSERVE-
5, an observational post-marketing safety surveillance registry of etanercept for
the treatment of psoriasis: a model for studying new psoriasis therapies. Psoriasis
Forum. 2010; 16: 3–7
Kimball, A.B., Pariser, D., Yamauchi, P.S., Menter, A., Teller, C.F., Shi, Y. et al. OBSERVE-5
interim analysis: an observational postmarketing safety registry of etanercept for
the treatment of psoriasis.J Am Acad Dermatol. 2013; 68: 756–764