Plegridy Observational Program

NCT02230969 | Completed

• 1 other identifier: 105MS401
• Study Type: observational
• Target: 1,208
• Locations: 13 countries
• Sites: 150

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.

Conditions

Relapsing Forms of Multiple Sclerosis

Keywords

peginterferon; relapsing; pegylated; Subcutaneous; Injectable; Multiple Sclerosis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (16)

• 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

Study Arms (1)

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

Interventions

peginterferon beta-1a DRUG

Administered as specified in the treatment arm

Also known as: BIIB017, PEG IFN β-1a, Plegridy, PEGylated Interferon Beta-1a

peginterferon beta-1a

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (152)

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Homewood, Alabama, 35209, United States

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Gilbert, Arizona, 85234, United States

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Scottsdale, Arizona, 85258, United States

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Berkeley, California, 94705, United States

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California City, California, 93449, United States

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Hanford, California, 93230, United States

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Orange, California, 92868, United States

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Basalt, Colorado, 81621, United States

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Colorado Springs, Colorado, 80907, United States

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Washington D.C., District of Columbia, 20007, United States

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Washington D.C., District of Columbia, 20037, United States

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Delray Beach, Florida, 33445, United States

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Atlanta, Georgia, 30327, United States

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Schaumburg, Illinois, 60173, United States

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Indianapolis, Indiana, 46256, United States

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Des Moines, Iowa, 50314, United States

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Iowa City, Iowa, 52242, United States

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Louisville, Kentucky, 40207, United States

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New Orleans, Louisiana, 70121, United States

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Scarborough, Maine, 04074, United States

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Boston, Massachusetts, 02215, United States

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Lexington, Massachusetts, 02421, United States

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Worcester, Massachusetts, 01655, United States

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Southfield, Michigan, 48034, United States

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Golden Valley, Minnesota, 55422, United States

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St Louis, Missouri, 63131, United States

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Great Falls, Montana, 59405, United States

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Lebanon, New Hampshire, 03756, United States

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Freehold, New Jersey, 07728, United States

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Albuquerque, New Mexico, 87131, United States

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Buffalo, New York, 14203, United States

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New Hyde Park, New York, 11042, United States

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New York, New York, 10016, United States

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Staten Island, New York, 10306, United States

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Charlotte, North Carolina, 28203, United States

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Hickory, North Carolina, 28602, United States

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Raleigh, North Carolina, 27607, United States

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Dayton, Ohio, 45417, United States

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Dayton, Ohio, 45459, United States

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Oklahoma City, Oklahoma, 73104, United States

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Oklahoma City, Oklahoma, 73112, United States

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Portland, Oregon, 97225, United States

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Pittsburgh, Pennsylvania, 15212, United States

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Port Royal, South Carolina, 29935, United States

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Knoxville, Tennessee, 37934, United States

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Bedford, Texas, 76021, United States

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Salt Lake City, Utah, 84103, United States

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Richmond, Virginia, 23298, United States

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Virginia Beach, Virginia, 23456, United States

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Milwaukee, Wisconsin, 53215, United States

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Camperdown, New South Wales, 2050, Australia

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New Lambton Heights, New South Wales, 2305, Australia

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Auchenflower, Queensland, 4066, Australia

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Bedford Park, South Australia, 5042, Australia

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Fitzroy, Victoria, 3065, Australia

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Heidelberg, Victoria, 3084, Australia

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Linz, 4021, Austria

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Vienna, 1180, Austria

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Calgary, Alberta, T2N2T9, Canada

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Saint John, New Brunswick, E2K 5S9, Canada

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Halifax, Nova Scotia, B3H4K4, Canada

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Sydney, Nova Scotia, B1P 1P3, Canada

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Barrie, Ontario, L4M5K3, Canada

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Cambridge, Ontario, N1R7L6, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Gatineau, Quebec, J9J 0A5, Canada

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Esbjerg, 6700, Denmark

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Glostrup Municipality, 2600, Denmark

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Sønderborg, 6400, Denmark

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Nîmes, Gard, 30029, France

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Toulouse, Haute Garonne, 31093, France

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Montpellier, Herault, 34295, France

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Rennes, Ille Et Vilaine, 35033, France

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St-Malo, Ille Et Vilaine, 35403, France

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Le Mans, Sarthe, 72037, France

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La Seyne-sur-Mer, Var, 83500, France

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Poitiers, Vienne, 86021, France

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Mantes-la-Jolie, Yvelines, 78201, France

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Gonesse, 95503, France

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Aalen, Baden-Wurttemberg, 73433, Germany

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Freiburg im Breisgau, Baden-Wurttemberg, 79098, Germany

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Heidenheim, Baden-Wurttemberg, 89518, Germany

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Ladenburg, Baden-Wurttemberg, 68526, Germany

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Pforzheim, Baden-Wurttemberg, 75172, Germany

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Stuttgart, Baden-Wurttemberg, 70182, Germany

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Bamberg, Bavaria, 96052, Germany

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Munich, Bavaria, 81825, Germany

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Regensburg, Bavaria, 93053, Germany

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Regensburg, Bavaria, 93095, Germany

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Rüdersdorf, Brandenburg, 15562, Germany

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Bad Homburg, Hesse, 61348, Germany

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Butzbach, Hesse, 35510, Germany

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Frankfurt am Main, Hesse, 60313, Germany

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Gelnhausen, Hesse, 63571, Germany

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Kassel, Hesse, 34121, Germany

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Göttingen, Lower Saxony, 37073, Germany

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Sande, Lower Saxony, 26452, Germany

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Stade, Lower Saxony, 21682, Germany

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Aachen, North Rhine-Westphalia, 52062, Germany

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Bonn, North Rhine-Westphalia, 53127, Germany

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Cologne, North Rhine-Westphalia, 50935, Germany

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Düsseldorf, North Rhine-Westphalia, 40211, Germany

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Siegen, North Rhine-Westphalia, 57076, Germany

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Kandel, Rhineland-Palatinate, 76870, Germany

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Ludwigshafen am Rhein, Rhineland-Palatinate, 67059, Germany

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Chemnitz, Saxony, 09117, Germany

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Leipzig, Saxony, 04229, Germany

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Itzehoe, Schleswig-Holstein, 25524, Germany

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Kiel, Schleswig-Holstein, 24105, Germany

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Altenburg, Thuringia, 04600, Germany

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Erfurt, Thuringia, 99096, Germany

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Jena, Thuringia, 07747, Germany

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Stadtroda, Thuringia, 07646, Germany

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Berlin, 10713, Germany

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Berlin, 12099, Germany

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Berlin, 14169, Germany

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Hamburg, 20249, Germany

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Hamburg, 22179, Germany

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Dublin, DUBLIN 4, Ireland

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Bergamo, 24127, Italy

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Cagliari, 09126, Italy

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Catanzaro, 88100, Italy

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Florence, 50134, Italy

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Genova, 16153, Italy

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Messina, 98121, Italy

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Milan, 20133, Italy

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Napoli, 80138, Italy

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Roma, 00133, Italy

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Roma, 00152, Italy

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Roma, 00189, Italy

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Blaricum, 1261 AN, Netherlands

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Breda, 4818 CK, Netherlands

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Hoorn, 1624 NP, Netherlands

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Guimarães, 4835-044, Portugal

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Setúbal, 2910-446, Portugal

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Cadiz, 11009, Spain

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Córdoba, 14011, Spain

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Málaga, 29010, Spain

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Seville, 41014, Spain

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Seville, 41071, Spain

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Aarau, 5001, Switzerland

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Basel, 4031, Switzerland

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Bern, 3010, Switzerland

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Lucerne, 6000, Switzerland

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Irvine, Ayrshire, KA128SS, United Kingdom

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Truro, Cornwall, TR13LJ, United Kingdom

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London, Greater London, NW3 2QG, United Kingdom

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Salford, Greater Manchester, M6 8HD, United Kingdom

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Inverness, Highland Region, IV2 3UJ, United Kingdom

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Leicester, Leicestershire, LE5 4 PW, United Kingdom

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Glasgow, Strathclyde, G51 4TF, United Kingdom

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Swansea, SA6 6NL, United Kingdom

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MeSH Terms

Conditions

Recurrence; Multiple Sclerosis

Interventions

peginterferon beta-1a

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: September 3, 2014
• Study Start: November 12, 2014
• Primary Completion: January 20, 2022
• Study Completion: January 20, 2022
• Last Updated: September 26, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share

Locations

ES (5); IE (1); NL (3); AU (6); CH (4); DK (3); DE (39); US (50); PT (2); IT (11); FR (10); GB (8); CA (8)