Plegridy Observational Program (POP)

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

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.

Study Overview

• Status: Completed
• Conditions: Relapsing Forms of Multiple Sclerosis
• Intervention / Treatment: Drug: peginterferon beta-1a

• Study Type: Observational
• Enrollment (Actual): 1208

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Research Site
    • New Lambton Heights, New South Wales, Australia, 2305
      • Research Site
  • Queensland
    • Auchenflower, Queensland, Australia, 4066
      • Research Site
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Research Site
  • Victoria
    • Fitzroy, Victoria, Australia, 3065
      • Research Site
    • Heidelberg, Victoria, Australia, 3084
      • Research Site
• Austria
  • Linz, Austria, 4021
    • Research Site
  • Vienna, Austria, 1180
    • Research Site
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N2T9
      • Research Site
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2K 5S9
      • Research Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H4K4
      • Research Site
    • Sydney, Nova Scotia, Canada, B1P 1P3
      • Research Site
  • Ontario
    • Barrie, Ontario, Canada, L4M5K3
      • Research Site
    • Cambridge, Ontario, Canada, N1R7L6
      • Research Site
    • Toronto, Ontario, Canada, M4N 3M5
      • Research Site
  • Quebec
    • Gatineau, Quebec, Canada, J9J 0A5
      • Research Site
• Denmark
  • Esbjerg, Denmark, 6700
    • Research Site
  • Glostrup, Denmark, 2600
    • Research Site
  • Sonderborg, Denmark, 6400
    • Research Site
• France
  • Gonesse, France, 95503
    • Research Site
  • Gard
    • Nimes, Gard, France, 30029
      • Research Site
  • Haute Garonne
    • Toulouse cedex 9, Haute Garonne, France, 31093
      • Research Site
  • Herault
    • Montpellier, Herault, France, 34295
      • Research Site
  • Ille Et Vilaine
    • Rennes cedex 09, Ille Et Vilaine, France, 35033
      • Research Site
    • Saint Malo cedex, Ille Et Vilaine, France, 35403
      • Research Site
  • Sarthe
    • Le Mans cedex 9, Sarthe, France, 72037
      • Research Site
  • Var
    • La Seyne sur Mer, Var, France, 83500
      • Research Site
  • Vienne
    • Poitiers cedex, Vienne, France, 86021
      • Research Site
  • Yvelines
    • Mantes La Jolie cedex, Yvelines, France, 78201
      • Research Site
• Germany
  • Berlin, Germany, 10713
    • Research Site
  • Berlin, Germany, 14169
    • Research Site
  • Berlin, Germany, 12099
    • Research Site
  • Hamburg, Germany, 20249
    • Research Site
  • Hamburg, Germany, 22179
    • Research Site
  • Baden Wuerttemberg
    • Aalen, Baden Wuerttemberg, Germany, 73433
      • Research Site
    • Freiburg, Baden Wuerttemberg, Germany, 79098
      • Research Site
    • Heidenheim, Baden Wuerttemberg, Germany, 89518
      • Research Site
    • Ladenburg, Baden Wuerttemberg, Germany, 68526
      • Research Site
    • Pforzheim, Baden Wuerttemberg, Germany, 75172
      • Research Site
    • Stuttgart, Baden Wuerttemberg, Germany, 70182
      • Research Site
  • Bayern
    • Bamberg, Bayern, Germany, 96052
      • Research Site
    • Muenchen, Bayern, Germany, 81825
      • Research Site
    • Regensburg, Bayern, Germany, 93095
      • Research Site
    • Regensburg, Bayern, Germany, 93053
      • Research Site
  • Brandenburg
    • Ruedersdorf, Brandenburg, Germany, 15562
      • Research Site
  • Hessen
    • Bad Homburg, Hessen, Germany, 61348
      • Research Site
    • Butzbach, Hessen, Germany, 35510
      • Research Site
    • Frankfurt, Hessen, Germany, 60313
      • Research Site
    • Gelnhausen, Hessen, Germany, 63571
      • Research Site
    • Kassel, Hessen, Germany, 34121
      • Research Site
  • Niedersachsen
    • Gottingen, Niedersachsen, Germany, 37073
      • Research Site
    • Sande, Niedersachsen, Germany, 26452
      • Research Site
    • Stade, Niedersachsen, Germany, 21682
      • Research Site
  • Nordrhein Westfalen
    • Aachen, Nordrhein Westfalen, Germany, 52062
      • Research Site
    • Bonn, Nordrhein Westfalen, Germany, 53127
      • Research Site
    • Duesseldorf, Nordrhein Westfalen, Germany, 40211
      • Research Site
    • Koeln, Nordrhein Westfalen, Germany, 50935
      • Research Site
    • Siegen, Nordrhein Westfalen, Germany, 57076
      • Research Site
  • Rheinland Pfalz
    • Kandel, Rheinland Pfalz, Germany, 76870
      • Research Site
    • Ludwigshafen, Rheinland Pfalz, Germany, 67059
      • Research Site
  • Sachsen
    • Chemnitz, Sachsen, Germany, 09117
      • Research Site
    • Leipzig, Sachsen, Germany, 04229
      • Research Site
  • Schleswig Holstein
    • Itzehoe, Schleswig Holstein, Germany, 25524
      • Research Site
    • Kiel, Schleswig Holstein, Germany, 24105
      • Research Site
  • Thueringen
    • Altenburg, Thueringen, Germany, 04600
      • Research Site
    • Erfurt, Thueringen, Germany, 99096
      • Research Site
    • Jena, Thueringen, Germany, 07747
      • Research Site
    • Stadtroda, Thueringen, Germany, 07646
      • Research Site
• Ireland
  • Dublin, Ireland, DUBLIN 4
    • Research Site
• Italy
  • Bergamo, Italy, 24127
    • Research Site
  • Cagliari, Italy, 09126
    • Research Site
  • Catanzaro, Italy, 88100
    • Research Site
  • Firenze, Italy, 50134
    • Research Site
  • Genova, Italy, 16153
    • Research Site
  • Messina, Italy, 98121
    • Research Site
  • Milano, Italy, 20133
    • Research Site
  • Napoli, Italy, 80138
    • Research Site
  • Roma, Italy, 00152
    • Research Site
  • Roma, Italy, 00189
    • Research Site
  • Roma, Italy, 00133
    • Research Site
• Netherlands
  • Blaricum, Netherlands, 1261 AN
    • Research Site
  • Breda, Netherlands, 4818 CK
    • Research Site
  • Hoorn, Netherlands, 1624 NP
    • Research Site
• Portugal
  • Guimarães, Portugal, 4835-044
    • Research Site
  • Setúbal, Portugal, 2910-446
    • Research Site
• Spain
  • Cadiz, Spain, 11009
    • Research Site
  • Cordoba, Spain, 14011
    • Research Site
  • Málaga, Spain, 29010
    • Research Site
  • Sevilla, Spain, 41014
    • Research Site
  • Sevilla, Spain, 41071
    • Research Site
• Switzerland
  • Aarau, Switzerland, 5001
    • Research Site
  • Basel, Switzerland, 4031
    • Research Site
  • Bern, Switzerland, 3010
    • Research Site
  • Luzern, Switzerland, 6000
    • Research Site
• United Kingdom
  • Swansea, United Kingdom, SA6 6NL
    • Research Site
  • Ayrshire
    • Irvine, Ayrshire, United Kingdom, KA128SS
      • Research Site
  • Cornwall
    • Truro, Cornwall, United Kingdom, TR13LJ
      • Research Site
  • Greater London
    • London, Greater London, United Kingdom, NW3 2QG
      • Research Site
  • Greater Manchester
    • Salford, Greater Manchester, United Kingdom, M6 8HD
      • Research Site
  • Highland Region
    • Inverness, Highland Region, United Kingdom, IV2 3UJ
      • Research Site
  • Leicestershire
    • Leicester, Leicestershire, United Kingdom, LE5 4 PW
      • Research Site
  • Strathclyde
    • Glasgow, Strathclyde, United Kingdom, G51 4TF
      • Research Site
• United States
  • Alabama
    • Homewood, Alabama, United States, 35209
      • Research Site
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Research Site
    • Scottsdale, Arizona, United States, 85258
      • Research Site
  • California
    • Berkeley, California, United States, 94705
      • Research Site
    • California City, California, United States, 93449
      • Research Site
    • Hanford, California, United States, 93230
      • Research Site
    • Orange, California, United States, 92868
      • Research Site
  • Colorado
    • Basalt, Colorado, United States, 81621
      • Research Site
    • Colorado Springs, Colorado, United States, 80907
      • Research Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Research Site
    • Washington, District of Columbia, United States, 20037
      • Research Site
  • Florida
    • Delray Beach, Florida, United States, 33445
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States, 30327
      • Research Site
  • Illinois
    • Schaumburg, Illinois, United States, 60173
      • Research Site
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Research Site
  • Iowa
    • Des Moines, Iowa, United States, 50314
      • Research Site
    • Iowa City, Iowa, United States, 52242
      • Research Site
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Research Site
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Research Site
  • Maine
    • Scarborough, Maine, United States, 04074
      • Research Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Research Site
    • Lexington, Massachusetts, United States, 02421
      • Research Site
    • Worcester, Massachusetts, United States, 01655
      • Research Site
  • Michigan
    • Southfield, Michigan, United States, 48034
      • Research Site
  • Minnesota
    • Golden Valley, Minnesota, United States, 55422
      • Research Site
  • Missouri
    • Saint Louis, Missouri, United States, 63131
      • Research Site
  • Montana
    • Great Falls, Montana, United States, 59405
      • Research Site
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Research Site
  • New Jersey
    • Freehold, New Jersey, United States, 07728
      • Research Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • Research Site
  • New York
    • Buffalo, New York, United States, 14203
      • Research Site
    • New Hyde Park, New York, United States, 11042
      • Research Site
    • New York, New York, United States, 10016
      • Research Site
    • Staten Island, New York, United States, 10306
      • Research Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Research Site
    • Hickory, North Carolina, United States, 28602
      • Research Site
    • Raleigh, North Carolina, United States, 27607
      • Research Site
  • Ohio
    • Dayton, Ohio, United States, 45417
      • Research Site
    • Dayton, Ohio, United States, 45459
      • Research Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Research Site
    • Oklahoma City, Oklahoma, United States, 73104
      • Research Site
  • Oregon
    • Portland, Oregon, United States, 97225
      • Research Site
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Research Site
  • South Carolina
    • Port Royal, South Carolina, United States, 29935
      • Research Site
  • Tennessee
    • Knoxville, Tennessee, United States, 37934
      • Research Site
  • Texas
    • Bedford, Texas, United States, 76021
      • Research Site
  • Utah
    • Salt Lake City, Utah, United States, 84103
      • Research Site
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Research Site
    • Virginia Beach, Virginia, United States, 23456
      • Research Site
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study will be conducted in participants with relapsing forms of MS who are newly or currently prescribed Plegridy as prescribed under routine clinical practice and participants who participated in Study 105MS302 (NCT01332019) or Study 105MS303 (NCT01939002).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: peginterferon beta-1a; Administered as specified in the treatment arm; Other Names: Plegridy; PEG IFN β-1a; BIIB017; PEGylated Interferon Beta-1a

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Biogen

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2014
• Primary Completion (Actual): January 20, 2022
• Study Completion (Actual): January 20, 2022

Study Registration Dates

• First Submitted: August 29, 2014
• First Submitted That Met QC Criteria: August 29, 2014
• First Posted (Estimate): September 3, 2014

Study Record Updates

• Last Update Posted (Actual): September 26, 2022
• Last Update Submitted That Met QC Criteria: September 23, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Subcutaneous; peginterferon; relapsing; Injectable; pegylated
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Physiological Effects of Drugs; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Immunologic Factors; Adjuvants, Immunologic; Interferons; Interferon beta-1a; Interferon-beta
• Other Study ID Numbers: 105MS401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/