Relapsing Forms of Multiple SclerosisPOPNCT02230969
Plegridy Observational Program
An observational study of Relapsing Forms of Multiple Sclerosis, run by Biogen at 152 sites in 14 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsing Forms of Multiple Sclerosis
- What is being tested?
- peginterferon beta-1a
- How many people
- 1,208 participants
- Where
- 152 sitesin 14 countries
- Study dates
- 12 Nov 2014to 20 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
152 sites in 14 countries.
152 sites in 14 countries
United States50 sites
Research Site
Albuquerque, New Mexico, 87131
Research Site
Atlanta, Georgia, 30327
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Basalt, Colorado, 81621
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Bedford, Texas, 76021
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Berkeley, California, 94705
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Boston, Massachusetts, 02215
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Buffalo, New York, 14203
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California City, California, 93449
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Charlotte, North Carolina, 28203
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Colorado Springs, Colorado, 80907
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Dayton, Ohio, 45417
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Dayton, Ohio, 45459
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Delray Beach, Florida, 33445
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Des Moines, Iowa, 50314
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Freehold, New Jersey, 07728
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Gilbert, Arizona, 85234
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Golden Valley, Minnesota, 55422
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Great Falls, Montana, 59405
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Hanford, California, 93230
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Hickory, North Carolina, 28602
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Homewood, Alabama, 35209
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Indianapolis, Indiana, 46256
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Iowa City, Iowa, 52242
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Knoxville, Tennessee, 37934
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Lebanon, New Hampshire, 03756
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Lexington, Massachusetts, 02421
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Louisville, Kentucky, 40207
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Milwaukee, Wisconsin, 53215
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New Hyde Park, New York, 11042
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New Orleans, Louisiana, 70121
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New York, New York, 10016
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Oklahoma City, Oklahoma, 73104
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Oklahoma City, Oklahoma, 73112
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Orange, California, 92868
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Pittsburgh, Pennsylvania, 15212
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Port Royal, South Carolina, 29935
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Portland, Oregon, 97225
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Raleigh, North Carolina, 27607
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Richmond, Virginia, 23298
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Salt Lake City, Utah, 84103
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Scarborough, Maine, 04074
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Schaumburg, Illinois, 60173
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Scottsdale, Arizona, 85258
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Southfield, Michigan, 48034
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St Louis, Missouri, 63131
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Staten Island, New York, 10306
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Virginia Beach, Virginia, 23456
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Washington D.C., District of Columbia, 20007
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Washington D.C., District of Columbia, 20037
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Worcester, Massachusetts, 01655
Germany39 sites
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Aachen, North Rhine-Westphalia, 52062
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Aalen, Baden-Wurttemberg, 73433
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Altenburg, Thuringia, 04600
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Bad Homburg, Hesse, 61348
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Bamberg, Bavaria, 96052
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Berlin, 10713
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Berlin, 12099
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Berlin, 14169
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Bonn, North Rhine-Westphalia, 53127
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Butzbach, Hesse, 35510
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Chemnitz, Saxony, 09117
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Cologne, North Rhine-Westphalia, 50935
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Düsseldorf, North Rhine-Westphalia, 40211
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Erfurt, Thuringia, 99096
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Frankfurt am Main, Hesse, 60313
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Freiburg im Breisgau, Baden-Wurttemberg, 79098
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Gelnhausen, Hesse, 63571
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Göttingen, Lower Saxony, 37073
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Hamburg, 20249
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Hamburg, 22179
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Heidenheim, Baden-Wurttemberg, 89518
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Itzehoe, Schleswig-Holstein, 25524
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Jena, Thuringia, 07747
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Kandel, Rhineland-Palatinate, 76870
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Kassel, Hesse, 34121
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Kiel, Schleswig-Holstein, 24105
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Ladenburg, Baden-Wurttemberg, 68526
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Leipzig, Saxony, 04229
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Ludwigshafen am Rhein, Rhineland-Palatinate, 67059
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Munich, Bavaria, 81825
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Pforzheim, Baden-Wurttemberg, 75172
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Regensburg, Bavaria, 93053
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Regensburg, Bavaria, 93095
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Rüdersdorf, Brandenburg, 15562
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Sande, Lower Saxony, 26452
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Siegen, North Rhine-Westphalia, 57076
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Stade, Lower Saxony, 21682
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Stadtroda, Thuringia, 07646
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Stuttgart, Baden-Wurttemberg, 70182
Italy11 sites
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Bergamo, 24127
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Cagliari, 09126
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Catanzaro, 88100
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Florence, 50134
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Genova, 16153
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Messina, 98121
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Milan, 20133
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Naples, 80138
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Roma, 00133
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Roma, 00152
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Roma, 00189
France10 sites
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Gonesse, 95503
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La Seyne-sur-Mer, Var, 83500
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Le Mans, Sarthe, 72037
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Mantes-la-Jolie, Yvelines, 78201
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Montpellier, Herault, 34295
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Nîmes, Gard, 30029
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Poitiers, Vienne, 86021
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Rennes, Ille Et Vilaine, 35033
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St-Malo, Ille Et Vilaine, 35403
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Toulouse, Haute Garonne, 31093
Canada8 sites
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Barrie, Ontario, L4M5K3
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Calgary, Alberta, T2N2T9
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Cambridge, Ontario, N1R7L6
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Gatineau, Quebec, J9J 0A5
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Halifax, Nova Scotia, B3H4K4
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Saint John, New Brunswick, E2K 5S9
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Sydney, Nova Scotia, B1P 1P3
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Toronto, Ontario, M4N 3M5
United Kingdom8 sites
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Glasgow, Strathclyde, G51 4TF
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Inverness, Highland Region, IV2 3UJ
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Irvine, Ayrshire, KA128SS
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Leicester, Leicestershire, LE5 4 PW
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London, Greater London, NW3 2QG
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Salford, Greater Manchester, M6 8HD
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Swansea, SA6 6NL
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Truro, Cornwall, TR13LJ
Australia6 sites
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Auchenflower, Queensland, 4066
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Bedford Park, South Australia, 5042
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Camperdown, New South Wales, 2050
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Fitzroy, Victoria, 3065
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Heidelberg, Victoria, 3084
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New Lambton Heights, New South Wales, 2305
Spain5 sites
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Cadiz, 11009
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Córdoba, 14011
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Málaga, 29010
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Seville, 41014
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Seville, 41071
Switzerland4 sites
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Aarau, 5001
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Basel, 4031
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Bern, 3010
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Lucerne, 6000
Denmark3 sites
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Esbjerg, 6700
Research site
Glostrup Municipality, 2600
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Sønderborg, 6400
Netherlands3 sites
Research Site
Blaricum, 1261 AN
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Breda, 4818 CK
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Hoorn, 1624 NP
Portugal2 sites
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Guimarães, 4835-044
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Setúbal, 2910-446
About this study
Official title: 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.
- Conditions
- Relapsing Forms of Multiple Sclerosis
- Being tested
- peginterferon beta-1a
- Keywords
- peginterferon, relapsing, pegylated, Subcutaneous, Injectable, Multiple Sclerosis
- Medical subject headings
- Recurrence, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peginterferon beta-1aDrug
Also called BIIB017, PEG IFN β-1a, Plegridy, PEGylated Interferon Beta-1a
Administered as specified in the treatment arm
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: peginterferon beta-1a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as measured by the incidence proportion of SAEs
Measured: Up to 5 years
Safety as measured by the incidence rate of SAEs
Measured: Up to 5 years
Clinical no evidence of disease activity (NEDA) as measured by the proportion of participants with no relapses
Measured: Up to 5 years
Clinical NEDA as measured by the proportion of participants with no disability progression
Measured: Up to 5 years
Secondary outcomes (16)
Prescription and utilization patterns as measured by prescribed dosing frequency
Measured: Up to 5 years
Prescription and utilization patterns as measured by duration of Plegridy use
Measured: Up to 5 years
Prescription and utilization patterns as measured by the primary reason for discontinuation of Plegridy
Measured: Up to 5 years
Relapse activity as measured by annualized relapse rate (ARR)
Measured: Up to 5 years
Relapse activity as measured by time to first relapse
Measured: Up to 5 years
Relapse activity as measured by the proportion of participants with relapse
Measured: Up to 5 years
Relapse activity as measured by the distribution of the number of relapses
Measured: 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.
Measured: Up to 5 years
Disability progression as measured by the time to sustained disability progression for at least six months
Measured: Up to 5 years
Incidence proportion of non-serious AEs leading to treatment discontinuation
Measured: Up to 5 years
Incidence rate of non-serious AEs leading to treatment discontinuation
Measured: 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
Measured: Up to 5 years
Changes in FLS assessment and FLS-VAS over time
Measured: 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.
Measured: 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.
Measured: 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
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study start12 Nov 2014
- Primary completion20 Jan 2022
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Forms of Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02230969
- Sponsor's protocol ID
- 105MS401
- Acronym
- POP
- Status last verified
- Sep 2022
- First submitted
- 29 Aug 2014
- Last updated
- 26 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plegridy™ (Peginterferon β-1a) Real World Effectiveness and Safety Observational Program
- ClinicalTrials.gov ID
- NCT02230969
- Acronym / sponsor ID
- POP / 105MS401
- Conditions
- Relapsing Forms of Multiple Sclerosis
- Keywords
- peginterferon, relapsing, pegylated, Subcutaneous, Injectable, Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,208 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2014 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 3 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| peginterferon beta-1a | – | Drug: peginterferon beta-1aPlegridy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- 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 (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| peginterferon beta-1aAlso: BIIB017, PEG IFN β-1a, Plegridy, PEGylated Interferon Beta-1aAdministered as specified in the treatment arm | Drug | peginterferon beta-1a |
Primary outcome
Safety as measured by the incidence proportion of SAEs
Time frame: Up to 5 years
Safety as measured by the incidence rate of SAEs
Time frame: Up to 5 years
Clinical no evidence of disease activity (NEDA) as measured by the proportion of participants with no relapses
Time frame: Up to 5 years
Clinical NEDA as measured by the proportion of participants with no disability progression
Time frame: Up to 5 years
16 secondary outcomes
Prescription and utilization patterns as measured by prescribed dosing frequency
Time frame: Up to 5 years
Prescription and utilization patterns as measured by duration of Plegridy use
Time frame: Up to 5 years
Prescription and utilization patterns as measured by the primary reason for discontinuation of Plegridy
Time frame: Up to 5 years
Relapse activity as measured by annualized relapse rate (ARR)
Time frame: Up to 5 years
Relapse activity as measured by time to first relapse
Time frame: Up to 5 years
Relapse activity as measured by the proportion of participants with relapse
Time frame: Up to 5 years
Relapse activity as measured by the distribution of the number of relapses
Time frame: Up to 5 years
Disability progression as measured by the proportion of participants with sustained progression for at least six months
Time frame: Up to 5 years
Disability progression as measured by the time to sustained disability progression for at least six months
Time frame: Up to 5 years
Incidence proportion of non-serious AEs leading to treatment discontinuation
Time frame: Up to 5 years
Incidence rate of non-serious AEs leading to treatment discontinuation
Time frame: 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
Time frame: Up to 5 years
Changes in FLS assessment and FLS-VAS over time
Time frame: Baseline to 5 years
Changes in EuroQoL EQ-5D, 3-level (EQ-5D-3L) score over time
Time frame: Baseline to 5 years
Treatment adherence as measured by changes in adherence over time as reported in the treatment adherence questionnaires
Time frame: 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
Time frame: Up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
152 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing Forms of Multiple Sclerosis, run by Biogen at 152 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 152 sites in United States, Germany, Italy, France, Canada and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as measured by the incidence proportion of SAEs (time frame: Up to 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2022.