Plegridy Observational Program

Relapsing Forms of Multiple Sclerosis Clinical Trial

— POP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02230969
• Other study ID #: 105MS401
• Status: Completed
• Start date: November 12, 2014
• Est. completion date: January 20, 2022

Study information

• Verified date: September 2022
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1208
• Est. completion date: January 20, 2022
• Est. primary completion date: January 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Relapsing Forms of Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• peginterferon beta-1a
Administered as specified in the treatment arm

Locations

Country	Name	City	State
Australia	Research Site	Auchenflower	Queensland
Australia	Research Site	Bedford Park	South Australia
Australia	Research Site	Camperdown	New South Wales
Australia	Research Site	Fitzroy	Victoria
Australia	Research Site	Heidelberg	Victoria
Australia	Research Site	New Lambton Heights	New South Wales
Austria	Research Site	Linz
Austria	Research Site	Vienna
Canada	Research Site	Barrie	Ontario
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Cambridge	Ontario
Canada	Research Site	Gatineau	Quebec
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Saint John	New Brunswick
Canada	Research Site	Sydney	Nova Scotia
Canada	Research Site	Toronto	Ontario
Denmark	Research Site	Esbjerg
Denmark	Research site	Glostrup
Denmark	Research Site	Sonderborg
France	Research Site	Gonesse
France	Research Site	La Seyne sur Mer	Var
France	Research Site	Le Mans cedex 9	Sarthe
France	Research Site	Mantes La Jolie cedex	Yvelines
France	Research Site	Montpellier	Herault
France	Research Site	Nimes	Gard
France	Research Site	Poitiers cedex	Vienne
France	Research Site	Rennes cedex 09	Ille Et Vilaine
France	Research Site	Saint Malo cedex	Ille Et Vilaine
France	Research Site	Toulouse cedex 9	Haute Garonne
Germany	Research Site	Aachen	Nordrhein Westfalen
Germany	Research Site	Aalen	Baden Wuerttemberg
Germany	Research Site	Altenburg	Thueringen
Germany	Research Site	Bad Homburg	Hessen
Germany	Research Site	Bamberg	Bayern
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Bonn	Nordrhein Westfalen
Germany	Research Site	Butzbach	Hessen
Germany	Research Site	Chemnitz	Sachsen
Germany	Research Site	Duesseldorf	Nordrhein Westfalen
Germany	Research Site	Erfurt	Thueringen
Germany	Research Site	Frankfurt	Hessen
Germany	Research Site	Freiburg	Baden Wuerttemberg
Germany	Research Site	Gelnhausen	Hessen
Germany	Research Site	Gottingen	Niedersachsen
Germany	Research Site	Hamburg
Germany	Research Site	Hamburg
Germany	Research Site	Heidenheim	Baden Wuerttemberg
Germany	Research Site	Itzehoe	Schleswig Holstein
Germany	Research Site	Jena	Thueringen
Germany	Research Site	Kandel	Rheinland Pfalz
Germany	Research Site	Kassel	Hessen
Germany	Research Site	Kiel	Schleswig Holstein
Germany	Research Site	Koeln	Nordrhein Westfalen
Germany	Research Site	Ladenburg	Baden Wuerttemberg
Germany	Research Site	Leipzig	Sachsen
Germany	Research Site	Ludwigshafen	Rheinland Pfalz
Germany	Research Site	Muenchen	Bayern
Germany	Research Site	Pforzheim	Baden Wuerttemberg
Germany	Research Site	Regensburg	Bayern
Germany	Research Site	Regensburg	Bayern
Germany	Research Site	Ruedersdorf	Brandenburg
Germany	Research Site	Sande	Niedersachsen
Germany	Research Site	Siegen	Nordrhein Westfalen
Germany	Research Site	Stade	Niedersachsen
Germany	Research Site	Stadtroda	Thueringen
Germany	Research Site	Stuttgart	Baden Wuerttemberg
Ireland	Research Site	Dublin
Italy	Research Site	Bergamo
Italy	Research Site	Cagliari
Italy	Research Site	Catanzaro
Italy	Research Site	Firenze
Italy	Research Site	Genova
Italy	Research Site	Messina
Italy	Research Site	Milano
Italy	Research Site	Napoli
Italy	Research Site	Roma
Italy	Research Site	Roma
Italy	Research Site	Roma
Netherlands	Research Site	Blaricum
Netherlands	Research Site	Breda
Netherlands	Research Site	Hoorn
Portugal	Research Site	Guimarães
Portugal	Research Site	Setúbal
Spain	Research Site	Cadiz
Spain	Research Site	Cordoba
Spain	Research Site	Málaga
Spain	Research Site	Sevilla
Spain	Research Site	Sevilla
Switzerland	Research Site	Aarau
Switzerland	Research Site	Basel
Switzerland	Research Site	Bern
Switzerland	Research Site	Luzern
United Kingdom	Research Site	Glasgow	Strathclyde
United Kingdom	Research Site	Inverness	Highland Region
United Kingdom	Research Site	Irvine	Ayrshire
United Kingdom	Research Site	Leicester	Leicestershire
United Kingdom	Research Site	London	Greater London
United Kingdom	Research Site	Salford	Greater Manchester
United Kingdom	Research Site	Swansea
United Kingdom	Research Site	Truro	Cornwall
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Atlanta	Georgia
United States	Research Site	Basalt	Colorado
United States	Research Site	Bedford	Texas
United States	Research Site	Berkeley	California
United States	Research Site	Boston	Massachusetts
United States	Research Site	Buffalo	New York
United States	Research Site	California City	California
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Colorado Springs	Colorado
United States	Research Site	Dayton	Ohio
United States	Research Site	Dayton	Ohio
United States	Research Site	Delray Beach	Florida
United States	Research Site	Des Moines	Iowa
United States	Research Site	Freehold	New Jersey
United States	Research Site	Gilbert	Arizona
United States	Research Site	Golden Valley	Minnesota
United States	Research Site	Great Falls	Montana
United States	Research Site	Hanford	California
United States	Research Site	Hickory	North Carolina
United States	Research Site	Homewood	Alabama
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Iowa City	Iowa
United States	Research Site	Knoxville	Tennessee
United States	Research Site	Lebanon	New Hampshire
United States	Research Site	Lexington	Massachusetts
United States	Research Site	Louisville	Kentucky
United States	Research Site	Milwaukee	Wisconsin
United States	Research Site	New Hyde Park	New York
United States	Research Site	New Orleans	Louisiana
United States	Research Site	New York	New York
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Orange	California
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Port Royal	South Carolina
United States	Research Site	Portland	Oregon
United States	Research Site	Raleigh	North Carolina
United States	Research Site	Richmond	Virginia
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Salt Lake City	Utah
United States	Research Site	Scarborough	Maine
United States	Research Site	Schaumburg	Illinois
United States	Research Site	Scottsdale	Arizona
United States	Research Site	Southfield	Michigan
United States	Research Site	Staten Island	New York
United States	Research Site	Virginia Beach	Virginia
United States	Research Site	Washington	District of Columbia
United States	Research Site	Washington	District of Columbia
United States	Research Site	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  Denmark,  France,  Germany,  Ireland,  Italy,  Netherlands,  Portugal,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety as measured by the incidence proportion of SAEs		Up to 5 years
Primary	Safety as measured by the incidence rate of SAEs		Up to 5 years
Primary	Clinical no evidence of disease activity (NEDA) as measured by the proportion of participants with no relapses		Up to 5 years
Primary	Clinical NEDA as measured by the proportion of participants with no disability progression		Up to 5 years
Secondary	Prescription and utilization patterns as measured by prescribed dosing frequency		Up to 5 years
Secondary	Prescription and utilization patterns as measured by duration of Plegridy use		Up to 5 years
Secondary	Prescription and utilization patterns as measured by the primary reason for discontinuation of Plegridy		Up to 5 years
Secondary	Relapse activity as measured by annualized relapse rate (ARR)		Up to 5 years
Secondary	Relapse activity as measured by time to first relapse		Up to 5 years
Secondary	Relapse activity as measured by the proportion of participants with relapse		Up to 5 years
Secondary	Relapse activity as measured by the distribution of the number of relapses		Up to 5 years
Secondary	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
Secondary	Disability progression as measured by the time to sustained disability progression for at least six months		Up to 5 years
Secondary	Incidence proportion of non-serious AEs leading to treatment discontinuation		Up to 5 years
Secondary	Incidence rate of non-serious AEs leading to treatment discontinuation		Up to 5 years
Secondary	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
Secondary	Changes in FLS assessment and FLS-VAS over time		Baseline to 5 years
Secondary	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
Secondary	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
Secondary	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