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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02230969
Registration number
NCT02230969
Ethics application status
Date submitted
29/08/2014
Date registered
3/09/2014
Titles & IDs
Public title
Plegridy Observational Program
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Scientific title
Plegridy™ (Peginterferon ß-1a) Real World Effectiveness and Safety Observational Program
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Secondary ID [1]
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105MS401
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Universal Trial Number (UTN)
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Trial acronym
POP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Relapsing Forms of Multiple Sclerosis
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0
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Drugs - peginterferon beta-1a
peginterferon beta-1a - Plegridy will not be supplied for this study. The study will collect data in an observational manner from participants who are prescribed Plegridy by physicians, according to the approved label in the respective country.
Treatment: Drugs: peginterferon beta-1a
Administered as specified in the treatment arm
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Intervention code [1]
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0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Safety as measured by the incidence proportion of SAEs
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Assessment method [1]
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0
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Timepoint [1]
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Up to 5 years
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Primary outcome [2]
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Safety as measured by the incidence rate of SAEs
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Assessment method [2]
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0
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Timepoint [2]
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Up to 5 years
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Primary outcome [3]
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Clinical no evidence of disease activity (NEDA) as measured by the proportion of participants with no relapses
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Assessment method [3]
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0
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Timepoint [3]
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Up to 5 years
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Primary outcome [4]
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Clinical NEDA as measured by the proportion of participants with no disability progression
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Assessment method [4]
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0
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Timepoint [4]
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Up to 5 years
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Secondary outcome [1]
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Prescription and utilization patterns as measured by prescribed dosing frequency
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Assessment method [1]
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0
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Timepoint [1]
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Up to 5 years
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Secondary outcome [2]
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0
Prescription and utilization patterns as measured by duration of Plegridy use
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Assessment method [2]
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0
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Timepoint [2]
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0
Up to 5 years
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Secondary outcome [3]
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0
Prescription and utilization patterns as measured by the primary reason for discontinuation of Plegridy
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Assessment method [3]
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0
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Timepoint [3]
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Up to 5 years
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Secondary outcome [4]
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0
Relapse activity as measured by annualized relapse rate (ARR)
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Assessment method [4]
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0
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Timepoint [4]
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0
Up to 5 years
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Secondary outcome [5]
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Relapse activity as measured by time to first relapse
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Assessment method [5]
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0
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Timepoint [5]
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Up to 5 years
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Secondary outcome [6]
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0
Relapse activity as measured by the proportion of participants with relapse
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Assessment method [6]
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0
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Timepoint [6]
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Up to 5 years
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Secondary outcome [7]
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0
Relapse activity as measured by the distribution of the number of relapses
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Assessment method [7]
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0
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Timepoint [7]
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Up to 5 years
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Secondary outcome [8]
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Disability progression as measured by the proportion of participants with sustained progression for at least six months
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Assessment method [8]
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Disability progression measured by the Expanded Disability Status Scale (EDSS). The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist. Participants with confirmed progression of disability in EDSS physical functional system scores will be defined as those who meet one of the following criteria: an increase of = 1 point from baseline system score of = 1 or an increase of = 2 points from baseline system score of 0 in at least 2 physical functional systems, or an increase of = 2 points from baseline system score of = 1 or an increase of = 3 points from baseline system score of 0 in any 1 physical functional system. Worsening must be confirmed on a subsequent examination using the same criterion in the same functional system(s) at least 6 months later.
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Timepoint [8]
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Up to 5 years
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Secondary outcome [9]
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Disability progression as measured by the time to sustained disability progression for at least six months
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Assessment method [9]
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Timepoint [9]
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Up to 5 years
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Secondary outcome [10]
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Incidence proportion of non-serious AEs leading to treatment discontinuation
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Assessment method [10]
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0
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Timepoint [10]
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Up to 5 years
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Secondary outcome [11]
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Incidence rate of non-serious AEs leading to treatment discontinuation
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Assessment method [11]
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0
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Timepoint [11]
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Up to 5 years
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Secondary outcome [12]
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Impact of the severity of FLS on the ability to successfully manage symptoms via prophylaxis as measured by the participant-reported FLS-VAS
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Assessment method [12]
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Timepoint [12]
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Up to 5 years
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Secondary outcome [13]
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Changes in FLS assessment and FLS-VAS over time
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Assessment method [13]
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Timepoint [13]
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Baseline to 5 years
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Secondary outcome [14]
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Changes in EuroQoL EQ-5D, 3-level (EQ-5D-3L) score over time
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Assessment method [14]
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The EQ-5D-3L is a standardized instrument for use as a measure of health outcome. It is a health questionnaire that consists of 2 pages - the EQ-5D descriptive system (page 2) and the EQ visual analogue scale (EQ VAS) (page 3). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems.
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Timepoint [14]
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Baseline to 5 years
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Secondary outcome [15]
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Treatment adherence as measured by changes in adherence over time as reported in the treatment adherence questionnaires
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Assessment method [15]
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Where pen/syringe collection is locally allowed, treatment adherence will also be assessed by the proportion of used auto-injector pens/pre-filled syringes out of the total number of pens/syringes prescribed.
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Timepoint [15]
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Baseline to 5 years
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Secondary outcome [16]
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Frequency of MS-related and non-MS-related physician visits, specialists' visits, use of physiotherapy, hospitalizations and lengths of stay, and emergency room/department visits
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Assessment method [16]
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Timepoint [16]
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Up to 5 years
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Eligibility
Key inclusion criteria
Key
* Patient with MS who is newly, or is currently, prescribed Plegridy according to local label including patients who participated in Study 105MS302 (NCT01332019) or Study 105MS303 (NCT01939002).
* Patient willing and able to complete patient-reported outcomes (PRO) with minimal assistance.
Key
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Concurrent enrollment in any clinical trial of an investigational product. Participation in non-interventional study can be allowed as long as this participation does not interfere with this protocol or is likely to affect the subject's ability to comply with the protocol.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/11/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
20/01/2022
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Sample size
Target
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Accrual to date
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Final
1208
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Research Site - Camperdown
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Research Site - New Lambton Heights
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2050 - Camperdown
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2305 - New Lambton Heights
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4066 - Auchenflower
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5042 - Bedford Park
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3065 - Fitzroy
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Recruitment postcode(s) [6]
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3084 - Heidelberg
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Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Biogen
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Ethics approval
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Summary
Brief summary
The primary objectives of the study are to determine the incidence of serious adverse events (SAEs) in participants with relapsing forms of multiple sclerosis (MS) in routine clinical practice and to assess the overall long-term clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine clinical practice. The secondary objectives of this study in this study population are to describe Plegridy prescription and utilization adherence patterns in routine clinical practice; to assess the specific long-term clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine clinical practice; to monitor the safety and tolerability of Plegridy in routine clinical practice by assessing the incidence of adverse events (AEs) of flu-like symptoms (FLS), injection site reactions (ISRs), and AEs (including laboratory abnormalities) leading to treatment discontinuation; to assess the effect of FLS on participant-reported effectiveness of, and satisfaction with, prophylactic management using a FLS-Visual Analog Scale (FLS-VAS); to evaluate the change in health-related quality of life (HRQoL), FLS, FLS-VAS, healthcare resource consumption, and treatment adherence over time.
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Trial website
https://clinicaltrials.gov/study/NCT02230969
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Medical Director
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Address
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Biogen
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://vivli.org/
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02230969