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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02230969




Registration number
NCT02230969
Ethics application status
Date submitted
29/08/2014
Date registered
3/09/2014
Date last updated
22/04/2020

Titles & IDs
Public title
Plegridy Observational Program
Scientific title
Plegridy™ (Peginterferon ß-1a) Real World Effectiveness and Safety Observational Program
Secondary ID [1] 0 0
105MS401
Universal Trial Number (UTN)
Trial acronym
POP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsing Forms of Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety as measured by the incidence proportion of SAEs
Timepoint [1] 0 0
Up to 5 years
Primary outcome [2] 0 0
Safety as measured by the incidence rate of SAEs
Timepoint [2] 0 0
Up to 5 years
Primary outcome [3] 0 0
Clinical no evidence of disease activity (NEDA) as measured by the proportion of participants with no relapses
Timepoint [3] 0 0
Up to 5 years
Primary outcome [4] 0 0
Clinical NEDA as measured by the proportion of participants with no disability progression
Timepoint [4] 0 0
Up to 5 years
Secondary outcome [1] 0 0
Prescription and utilization patterns as measured by prescribed dosing frequency
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [2] 0 0
Prescription and utilization patterns as measured by duration of Plegridy use
Timepoint [2] 0 0
Up to 5 years
Secondary outcome [3] 0 0
Prescription and utilization patterns as measured by the primary reason for discontinuation of Plegridy
Timepoint [3] 0 0
Up to 5 years
Secondary outcome [4] 0 0
Relapse activity as measured by annualized relapse rate (ARR)
Timepoint [4] 0 0
Up to 5 years
Secondary outcome [5] 0 0
Relapse activity as measured by time to first relapse
Timepoint [5] 0 0
Up to 5 years
Secondary outcome [6] 0 0
Relapse activity as measured by the proportion of participants with relapse
Timepoint [6] 0 0
Up to 5 years
Secondary outcome [7] 0 0
Relapse activity as measured by the distribution of the number of relapses
Timepoint [7] 0 0
Up to 5 years
Secondary outcome [8] 0 0
Disability progression as measured by the proportion of participants with sustained progression for at least six months - 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.
Timepoint [8] 0 0
Up to 5 years
Secondary outcome [9] 0 0
Disability progression as measured by the time to sustained disability progression for at least six months
Timepoint [9] 0 0
Up to 5 years
Secondary outcome [10] 0 0
Incidence proportion of non-serious AEs leading to treatment discontinuation
Timepoint [10] 0 0
Up to 5 years
Secondary outcome [11] 0 0
Incidence rate of non-serious AEs leading to treatment discontinuation
Timepoint [11] 0 0
Up to 5 years
Secondary outcome [12] 0 0
Impact of the severity of FLS on the ability to successfully manage symptoms via prophylaxis as measured by the participant-reported FLS-VAS
Timepoint [12] 0 0
Up to 5 years
Secondary outcome [13] 0 0
Changes in FLS assessment and FLS-VAS over time
Timepoint [13] 0 0
Baseline to 5 years
Secondary outcome [14] 0 0
Changes in EuroQoL EQ-5D, 3-level (EQ-5D-3L) score over time - 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.
Timepoint [14] 0 0
Baseline to 5 years
Secondary outcome [15] 0 0
Treatment adherence as measured by changes in adherence over time as reported in the treatment adherence questionnaires - 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.
Timepoint [15] 0 0
Baseline to 5 years
Secondary outcome [16] 0 0
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
Timepoint [16] 0 0
Up to 5 years

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Research Site - Camperdown
Recruitment hospital [2] 0 0
Research Site - New Lambton Heights
Recruitment hospital [3] 0 0
Research Site - Auchenflower
Recruitment hospital [4] 0 0
Research Site - Bedford Park
Recruitment hospital [5] 0 0
Research Site - Fitzroy
Recruitment hospital [6] 0 0
Research Site - Heidelberg
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [3] 0 0
4066 - Auchenflower
Recruitment postcode(s) [4] 0 0
5042 - Bedford Park
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Kentucky
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Maine
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Herault
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Catanzaro
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Firenze
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Messina
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Hoorn
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Ayrshire
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Cornwall
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Greater London
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Greater Manchester
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Highland Region
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United Kingdom
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Leicestershire
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United Kingdom
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Strathclyde
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United Kingdom
State/province [95] 0 0
Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biogen
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02230969
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Biogen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications