Multiple Sclerosis Clinical Trial

Plegridy Observational Program

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.

View Eligibility Criteria

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

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

1208

Study ID:

NCT02230969

Recruitment Status:

Completed

Sponsor:

Biogen

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There are 152 Locations for this study

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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 District of Columbia, 20007, United States
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Washington 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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Saint 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, T2N2T, Canada
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Saint John New Brunswick, E2K 5, Canada
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Halifax Nova Scotia, B3H4K, Canada
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Sydney Nova Scotia, B1P 1, Canada
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Barrie Ontario, L4M5K, Canada
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Cambridge Ontario, N1R7L, Canada
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Toronto Ontario, M4N 3, Canada
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Gatineau Quebec, J9J 0, Canada
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Esbjerg , 6700, Denmark
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Glostrup , 2600, Denmark
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Sonderborg , 6400, Denmark
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Nimes Gard, 30029, France
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Toulouse cedex 9 Haute Garonne, 31093, France
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Montpellier Herault, 34295, France
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Rennes cedex 09 Ille Et Vilaine, 35033, France
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Saint Malo cedex Ille Et Vilaine, 35403, France
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Le Mans cedex 9 Sarthe, 72037, France
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La Seyne sur Mer Var, 83500, France
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Poitiers cedex Vienne, 86021, France
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Mantes La Jolie cedex Yvelines, 78201, France
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Gonesse , 95503, France
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Aalen Baden Wuerttemberg, 73433, Germany
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Freiburg Baden Wuerttemberg, 79098, Germany
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Heidenheim Baden Wuerttemberg, 89518, Germany
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Ladenburg Baden Wuerttemberg, 68526, Germany
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Pforzheim Baden Wuerttemberg, 75172, Germany
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Stuttgart Baden Wuerttemberg, 70182, Germany
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Bamberg Bayern, 96052, Germany
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Muenchen Bayern, 81825, Germany
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Regensburg Bayern, 93053, Germany
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Regensburg Bayern, 93095, Germany
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Ruedersdorf Brandenburg, 15562, Germany
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Bad Homburg Hessen, 61348, Germany
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Butzbach Hessen, 35510, Germany
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Frankfurt Hessen, 60313, Germany
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Gelnhausen Hessen, 63571, Germany
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Kassel Hessen, 34121, Germany
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Gottingen Niedersachsen, 37073, Germany
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Sande Niedersachsen, 26452, Germany
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Stade Niedersachsen, 21682, Germany
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Aachen Nordrhein Westfalen, 52062, Germany
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Bonn Nordrhein Westfalen, 53127, Germany
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Duesseldorf Nordrhein Westfalen, 40211, Germany
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Koeln Nordrhein Westfalen, 50935, Germany
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Siegen Nordrhein Westfalen, 57076, Germany
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Kandel Rheinland Pfalz, 76870, Germany
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Ludwigshafen Rheinland Pfalz, 67059, Germany
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Chemnitz Sachsen, 09117, Germany
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Leipzig Sachsen, 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 Thueringen, 04600, Germany
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Erfurt Thueringen, 99096, Germany
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Jena Thueringen, 07747, Germany
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Stadtroda Thueringen, 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 , DUBLI, 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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Firenze , 50134, Italy
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Genova , 16153, Italy
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Messina , 98121, Italy
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Milano , 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 , Netherlands
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Breda , 4818 , Netherlands
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Hoorn , 1624 , Netherlands
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Guimarães , 4835-, Portugal
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Setúbal , 2910-, Portugal
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Cadiz , 11009, Spain
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Cordoba , 14011, Spain
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Málaga , 29010, Spain
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Sevilla , 41014, Spain
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Sevilla , 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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Luzern , 6000, Switzerland
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Irvine Ayrshire, KA128, United Kingdom
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Truro Cornwall, TR13L, United Kingdom
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London Greater London, NW3 2, United Kingdom
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Salford Greater Manchester, M6 8H, United Kingdom
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Inverness Highland Region, IV2 3, United Kingdom
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Leicester Leicestershire, LE5 4, United Kingdom
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Glasgow Strathclyde, G51 4, United Kingdom
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Swansea , SA6 6, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

1208

Study ID:

NCT02230969

Recruitment Status:

Completed

Sponsor:


Biogen

How clear is this clinincal trial information?

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