Date post: | 09-Jan-2017 |
Category: |
Health & Medicine |
Upload: | seneca-college-ontario-canada |
View: | 211 times |
Download: | 2 times |
Reference: Public Document NCT #: NCT00322439
Sponsor: Amgen Canada Inc.
By: Vivette Escueta, RPh
Presented at AAPS, 2015
Research Director: Professor Peivand Pirouzi
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
ETANERCEPT Medical Biologic Device Amgen Canada Enbrel
TNF Blocker Indicated for Chronic
Moderate to Severe Plaque Psoriasis
Relieve the symptoms of autoimmune disorders
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
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)
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
Phase IV, Prospective, Multicenter, Observational, Surveillance registry
Self-administered dose of etanercept
Evaluated at 6-months interval for 5 years.
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
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
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
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.
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
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
Use of Large database MarketScan registered 48,136 Psoriasis patients
Lack of internal comparator
Rare events may not be detected
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.
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.
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