Plegridy Observational Program

Study Overview
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Brief Summary
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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.

Official Title
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Plegridy™ (Peginterferon β-1a) Real World Effectiveness and Safety Observational Program

Conditions
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Relapsing Forms of Multiple Sclerosis

Intervention / Treatment
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* Drug: peginterferon beta-1a


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| peginterferon beta-1a<br>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. | Drug: peginterferon beta-1a<br>* Administered as specified in the treatment arm<br>* Other names: PEGylated Interferon Beta-1a;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as measured by the incidence proportion of SAEs |  | Up to 5 years | 
| Safety as measured by the incidence rate of SAEs |  | Up to 5 years | 
| Clinical no evidence of disease activity (NEDA) as measured by the proportion of participants with no relapses |  | Up to 5 years | 
| Clinical NEDA as measured by the proportion of participants with no disability progression |  | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prescription and utilization patterns as measured by prescribed dosing frequency |  | Up to 5 years | 
| Prescription and utilization patterns as measured by duration of Plegridy use |  | Up to 5 years | 
| Prescription and utilization patterns as measured by the primary reason for discontinuation of Plegridy |  | Up to 5 years | 
| Relapse activity as measured by annualized relapse rate (ARR) |  | Up to 5 years | 
| Relapse activity as measured by time to first relapse |  | Up to 5 years | 
| Relapse activity as measured by the proportion of participants with relapse |  | Up to 5 years | 
| Relapse activity as measured by the distribution of the number of relapses |  | Up to 5 years | 
| 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. | Up to 5 years | 
| Disability progression as measured by the time to sustained disability progression for at least six months |  | Up to 5 years | 
| Incidence proportion of non-serious AEs leading to treatment discontinuation |  | Up to 5 years | 
| Incidence rate of non-serious AEs leading to treatment discontinuation |  | Up to 5 years | 
| Impact of the severity of FLS on the ability to successfully manage symptoms via prophylaxis as measured by the participant-reported FLS-VAS |  | Up to 5 years | 
| Changes in FLS assessment and FLS-VAS over time |  | Baseline to 5 years | 
| 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. | Baseline to 5 years | 
| 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. | Baseline to 5 years | 
| 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 |  | Up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peginterferon, relapsing, pegylated, Subcutaneous, Injectable, Multiple Sclerosis