Clinical trial NCT02230969: Plegridy Observational Program
Official title: Plegridy™ (Peginterferon β-1a) Real World Effectiveness and Safety Observational Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsing Forms of Multiple Sclerosis
Keywords: peginterferon
relapsing
pegylated
Subcutaneous
Injectable
Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2014-09-03
Enrollment: 1208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety as measured by the incidence proportion of SAEs
timeFrame: Up to 5 years
measure: Safety as measured by the incidence rate of SAEs
timeFrame: Up to 5 years
measure: Clinical no evidence of disease activity (NEDA) as measured by the proportion of participants with no relapses
timeFrame: Up to 5 years
measure: Clinical NEDA as measured by the proportion of participants with no disability progression
timeFrame: Up to 5 years
Secondary outcomes:
measure: Prescription and utilization patterns as measured by prescribed dosing frequency
timeFrame: Up to 5 years
measure: Prescription and utilization patterns as measured by duration of Plegridy use
timeFrame: Up to 5 years
measure: Prescription and utilization patterns as measured by the primary reason for discontinuation of Plegridy
timeFrame: Up to 5 years
measure: Relapse activity as measured by annualized relapse rate (ARR)
timeFrame: Up to 5 years
measure: Relapse activity as measured by time to first relapse
timeFrame: Up to 5 years
measure: Relapse activity as measured by the proportion of participants with relapse
timeFrame: Up to 5 years
measure: Relapse activity as measured by the distribution of the number of relapses
timeFrame: Up to 5 years
measure: Disability progression as measured by the proportion of participants with sustained progression for at least six months
timeFrame: Up to 5 years
measure: Disability progression as measured by the time to sustained disability progression for at least six months
timeFrame: Up to 5 years
measure: Incidence proportion of non-serious AEs leading to treatment discontinuation
timeFrame: Up to 5 years
measure: Incidence rate of non-serious AEs leading to treatment discontinuation
timeFrame: Up to 5 years
measure: Impact of the severity of FLS on the ability to successfully manage symptoms via prophylaxis as measured by the participant-reported FLS-VAS
timeFrame: Up to 5 years
measure: Changes in FLS assessment and FLS-VAS over time
timeFrame: Baseline to 5 years
measure: Changes in EuroQoL EQ-5D, 3-level (EQ-5D-3L) score over time
timeFrame: Baseline to 5 years
measure: Treatment adherence as measured by changes in adherence over time as reported in the treatment adherence questionnaires
timeFrame: Baseline to 5 years
measure: 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
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Research Site
state: Alabama
city: Gilbert
country: United States
facility: Research Site
state: Arizona
city: Scottsdale
country: United States
facility: Research Site
state: Arizona
city: Berkeley
country: United States
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state: California
city: California City
country: United States
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state: California
city: Hanford
country: United States
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state: California
city: Orange
country: United States
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state: California
city: Basalt
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state: Colorado
city: Colorado Springs
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state: Colorado
city: Washington
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state: District of Columbia
city: Washington
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state: District of Columbia
city: Delray Beach
country: United States
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state: Florida
city: Atlanta
country: United States
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state: Georgia
city: Schaumburg
country: United States
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state: Illinois
city: Indianapolis
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state: Indiana
city: Des Moines
country: United States
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state: Iowa
city: Iowa City
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state: Iowa
city: Louisville
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state: Kentucky
city: New Orleans
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state: Louisiana
city: Scarborough
country: United States
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state: Maine
city: Boston
country: United States
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state: Massachusetts
city: Lexington
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state: Massachusetts
city: Worcester
country: United States
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state: Massachusetts
city: Southfield
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state: Michigan
city: Golden Valley
country: United States
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state: Minnesota
city: Saint Louis
country: United States
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state: Missouri
city: Great Falls
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state: Montana
city: Lebanon
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state: New Hampshire
city: Freehold
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state: New Jersey
city: Albuquerque
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state: New Mexico
city: Buffalo
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state: New York
city: New Hyde Park
country: United States
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state: New York
city: New York
country: United States
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state: New York
city: Staten Island
country: United States
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state: New York
city: Charlotte
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state: North Carolina
city: Hickory
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state: North Carolina
city: Raleigh
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state: North Carolina
city: Dayton
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state: Ohio
city: Dayton
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state: Ohio
city: Oklahoma City
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city: Oklahoma City
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city: Portland
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city: Pittsburgh
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city: Port Royal
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state: South Carolina
city: Knoxville
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city: Bedford
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city: Salt Lake City
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city: Richmond
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city: Virginia Beach
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city: Milwaukee
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city: Camperdown
country: Australia
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city: New Lambton Heights
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city: Auchenflower
country: Australia
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state: Queensland
city: Bedford Park
country: Australia
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state: South Australia
city: Fitzroy
country: Australia
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state: Victoria
city: Heidelberg
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state: Victoria
city: Linz
country: Austria
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country: Austria
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city: Calgary
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state: Alberta
city: Saint John
country: Canada
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state: New Brunswick
city: Halifax
country: Canada
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city: Sydney
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city: Barrie
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state: Ontario
city: Cambridge
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city: Toronto
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city: Gatineau
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state: Quebec
city: Esbjerg
country: Denmark
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city: Glostrup
country: Denmark
facility: Research site
city: Sonderborg
country: Denmark
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city: Nimes
country: France
facility: Research Site
state: Gard
city: Toulouse cedex 9
country: France
facility: Research Site
state: Haute Garonne
city: Montpellier
country: France
facility: Research Site
state: Herault
city: Rennes cedex 09
country: France
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state: Ille Et Vilaine
city: Saint Malo cedex
country: France
facility: Research Site
state: Ille Et Vilaine
city: Le Mans cedex 9
country: France
facility: Research Site
state: Sarthe
city: La Seyne sur Mer
country: France
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state: Var
city: Poitiers cedex
country: France
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state: Vienne
city: Mantes La Jolie cedex
country: France
facility: Research Site
state: Yvelines
city: Gonesse
country: France
facility: Research Site
city: Aalen
country: Germany
facility: Research Site
state: Baden Wuerttemberg
city: Freiburg
country: Germany
facility: Research Site
state: Baden Wuerttemberg
city: Heidenheim
country: Germany
facility: Research Site
state: Baden Wuerttemberg
city: Ladenburg
country: Germany
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state: Baden Wuerttemberg
city: Pforzheim
country: Germany
facility: Research Site
state: Baden Wuerttemberg
city: Stuttgart
country: Germany
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state: Baden Wuerttemberg
city: Bamberg
country: Germany
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state: Bayern
city: Muenchen
country: Germany
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state: Bayern
city: Regensburg
country: Germany
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state: Bayern
city: Regensburg
country: Germany
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state: Bayern
city: Ruedersdorf
country: Germany
facility: Research Site
state: Brandenburg
city: Bad Homburg
country: Germany
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city: Butzbach
country: Germany
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state: Hessen
city: Frankfurt
country: Germany
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state: Hessen
city: Gelnhausen
country: Germany
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city: Kassel
country: Germany
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state: Hessen
city: Gottingen
country: Germany
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city: Sande
country: Germany
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city: Stade
country: Germany
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state: Niedersachsen
city: Aachen
country: Germany
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state: Nordrhein Westfalen
city: Bonn
country: Germany
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state: Nordrhein Westfalen
city: Duesseldorf
country: Germany
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state: Nordrhein Westfalen
city: Koeln
country: Germany
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state: Nordrhein Westfalen
city: Siegen
country: Germany
facility: Research Site
state: Nordrhein Westfalen
city: Kandel
country: Germany
facility: Research Site
state: Rheinland Pfalz
city: Ludwigshafen
country: Germany
facility: Research Site
state: Rheinland Pfalz
city: Chemnitz
country: Germany
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state: Sachsen
city: Leipzig
country: Germany
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state: Sachsen
city: Itzehoe
country: Germany
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state: Schleswig Holstein
city: Kiel
country: Germany
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state: Schleswig Holstein
city: Altenburg
country: Germany
facility: Research Site
state: Thueringen
city: Erfurt
country: Germany
facility: Research Site
state: Thueringen
city: Jena
country: Germany
facility: Research Site
state: Thueringen
city: Stadtroda
country: Germany
facility: Research Site
state: Thueringen
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Dublin
country: Ireland
facility: Research Site
city: Bergamo
country: Italy
facility: Research Site
city: Cagliari
country: Italy
facility: Research Site
city: Catanzaro
country: Italy
facility: Research Site
city: Firenze
country: Italy
facility: Research Site
city: Genova
country: Italy
facility: Research Site
city: Messina
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Blaricum
country: Netherlands
facility: Research Site
city: Breda
country: Netherlands
facility: Research Site
city: Hoorn
country: Netherlands
facility: Research Site
city: Guimarães
country: Portugal
facility: Research Site
city: Setúbal
country: Portugal
facility: Research Site
city: Cadiz
country: Spain
facility: Research Site
city: Cordoba
country: Spain
facility: Research Site
city: Málaga
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Aarau
country: Switzerland
facility: Research Site
city: Basel
country: Switzerland
facility: Research Site
city: Bern
country: Switzerland
facility: Research Site
city: Luzern
country: Switzerland
facility: Research Site
city: Irvine
country: United Kingdom
facility: Research Site
state: Ayrshire
city: Truro
country: United Kingdom
facility: Research Site
state: Cornwall
city: London
country: United Kingdom
facility: Research Site
state: Greater London
city: Salford
country: United Kingdom
facility: Research Site
state: Greater Manchester
city: Inverness
country: United Kingdom
facility: Research Site
state: Highland Region
city: Leicester
country: United Kingdom
facility: Research Site
state: Leicestershire
city: Glasgow
country: United Kingdom
facility: Research Site
state: Strathclyde
city: Swansea
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: