Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-01-04 @ 1:56 PM
Study NCT ID:
NCT02230969
Status:
COMPLETED
Last Update Posted:
2022-09-26
First Post:
2014-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plegridy Observational Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C428112', 'term': 'peginterferon beta-1a'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1208}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-23', 'studyFirstSubmitDate': '2014-08-29', 'studyFirstSubmitQcDate': '2014-08-29', 'lastUpdatePostDateStruct': {'date': '2022-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'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', 'description': '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.'}, {'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', 'description': '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.'}, {'measure': 'Treatment adherence as measured by changes in adherence over time as reported in the treatment adherence questionnaires', 'timeFrame': 'Baseline to 5 years', 'description': '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.'}, {'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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['peginterferon', 'relapsing', 'pegylated', 'Subcutaneous', 'Injectable', 'Multiple Sclerosis'], 'conditions': ['Relapsing Forms of Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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).', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* 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).\n* Patient willing and able to complete patient-reported outcomes (PRO) with minimal assistance.\n\nKey Exclusion Criteria:\n\n* 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.\n\nNOTE: Other protocol defined Inclusion/Exclusion criteria may apply"}, 'identificationModule': {'nctId': 'NCT02230969', 'acronym': 'POP', 'briefTitle': 'Plegridy Observational Program', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'Plegridy™ (Peginterferon β-1a) Real World Effectiveness and Safety Observational Program', 'orgStudyIdInfo': {'id': '105MS401'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'peginterferon beta-1a', 'description': '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.', 'interventionNames': ['Drug: peginterferon beta-1a']}], 'interventions': [{'name': 'peginterferon beta-1a', 'type': 'DRUG', 'otherNames': ['BIIB017', 'PEG IFN β-1a', 'Plegridy', 'PEGylated Interferon Beta-1a'], 'description': 'Administered as specified in the treatment arm', 'armGroupLabels': ['peginterferon beta-1a']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Homewood', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.47177, 'lon': -86.80082}}, {'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '94705', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '93449', 'city': 'California City', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.1258, 'lon': -117.9859}}, {'zip': '93230', 'city': 'Hanford', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.32745, 'lon': -119.64568}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '81621', 'city': 'Basalt', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.36887, 'lon': -107.03282}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33445', 'city': 'Delray Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 26.46146, 'lon': -80.07282}}, {'zip': '30327', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60173', 'city': 'Schaumburg', 'state': 'Illinois', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.03336, 'lon': -88.08341}}, {'zip': '46256', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '50314', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '40207', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '04074', 'city': 'Scarborough', 'state': 'Maine', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 43.57814, 'lon': -70.32172}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02421', 'city': 'Lexington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.44732, 'lon': -71.2245}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '48034', 'city': 'Southfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.47337, 'lon': -83.22187}}, {'zip': '55422', 'city': 'Golden Valley', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 45.00969, 'lon': -93.34912}}, {'zip': '63131', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '59405', 'city': 'Great Falls', 'state': 'Montana', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 47.50024, 'lon': -111.30081}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '07728', 'city': 'Freehold', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.26011, 'lon': -74.27376}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '11042', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10306', 'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}, {'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28602', 'city': 'Hickory', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.73319, 'lon': -81.3412}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '45417', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '45459', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97225', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '15212', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29935', 'city': 'Port Royal', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.37896, 'lon': -80.69265}}, {'zip': '37934', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '76021', 'city': 'Bedford', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.84402, 'lon': -97.14307}}, {'zip': '84103', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '23456', 'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}, {'zip': '53215', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '2050', 'city': 'Camperdown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': '2305', 'city': 'New Lambton Heights', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -32.92466, 'lon': 151.69364}}, {'zip': '4066', 'city': 'Auchenflower', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -27.47443, 'lon': 152.99213}}, {'zip': '5042', 'city': 'Bedford Park', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -35.02204, 'lon': 138.56815}}, {'zip': '3065', 'city': 'Fitzroy', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -37.79839, 'lon': 144.97833}}, {'zip': '3084', 'city': 'Heidelberg', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -37.75, 'lon': 145.06667}}, {'zip': '4021', 'city': 'Linz', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '1180', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': 'T2N2T9', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'E2K 5S9', 'city': 'Saint John', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 45.27076, 'lon': -66.05616}}, {'zip': 'B3H4K4', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'B1P 1P3', 'city': 'Sydney', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 46.1351, 'lon': -60.1831}}, {'zip': 'L4M5K3', 'city': 'Barrie', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 44.40011, 'lon': -79.66634}}, {'zip': 'N1R7L6', 'city': 'Cambridge', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 43.3601, 'lon': -80.31269}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'J9J 0A5', 'city': 'Gatineau', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 45.47723, 'lon': -75.70164}}, {'zip': '6700', 'city': 'Esbjerg', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.47028, 'lon': 8.45187}}, {'zip': '2600', 'city': 'Glostrup Municipality', 'country': 'Denmark', 'facility': 'Research site', 'geoPoint': {'lat': 55.6666, 'lon': 12.40377}}, {'zip': '6400', 'city': 'Sønderborg', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 54.90896, 'lon': 9.78917}}, {'zip': '30029', 'city': 'Nîmes', 'state': 'Gard', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '31093', 'city': 'Toulouse', 'state': 'Haute Garonne', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '34295', 'city': 'Montpellier', 'state': 'Herault', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '35033', 'city': 'Rennes', 'state': 'Ille Et Vilaine', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '35403', 'city': 'St-Malo', 'state': 'Ille Et Vilaine', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 48.64738, 'lon': -2.00877}}, {'zip': '72037', 'city': 'Le Mans', 'state': 'Sarthe', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'zip': '83500', 'city': 'La Seyne-sur-Mer', 'state': 'Var', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 43.10322, 'lon': 5.87816}}, {'zip': '86021', 'city': 'Poitiers', 'state': 'Vienne', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '78201', 'city': 'Mantes-la-Jolie', 'state': 'Yvelines', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 48.99048, 'lon': 1.7167}}, {'zip': '95503', 'city': 'Gonesse', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 48.98693, 'lon': 2.44892}}, {'zip': '73433', 'city': 'Aalen', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 48.83777, 'lon': 10.0933}}, {'zip': '79098', 'city': 'Freiburg im Breisgau', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '89518', 'city': 'Heidenheim', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 48.67798, 'lon': 10.15162}}, {'zip': '68526', 'city': 'Ladenburg', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.47307, 'lon': 8.60896}}, {'zip': '75172', 'city': 'Pforzheim', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 48.88436, 'lon': 8.69892}}, {'zip': '70182', 'city': 'Stuttgart', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '96052', 'city': 'Bamberg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.89873, 'lon': 10.90067}}, {'zip': '81825', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '93053', 'city': 'Regensburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '93095', 'city': 'Regensburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '15562', 'city': 'Rüdersdorf', 'state': 'Brandenburg', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.46927, 'lon': 13.78631}}, {'zip': '61348', 'city': 'Bad Homburg', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.22683, 'lon': 8.61816}}, {'zip': '35510', 'city': 'Butzbach', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.43395, 'lon': 8.67122}}, {'zip': '60313', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '63571', 'city': 'Gelnhausen', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.20164, 'lon': 9.18742}}, {'zip': '34121', 'city': 'Kassel', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.31667, 'lon': 9.5}}, {'zip': '37073', 'city': 'Göttingen', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'zip': '26452', 'city': 'Sande', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 53.50489, 'lon': 8.01418}}, {'zip': '21682', 'city': 'Stade', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 53.59407, 'lon': 9.47302}}, {'zip': '52062', 'city': 'Aachen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '53127', 'city': 'Bonn', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '50935', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '40211', 'city': 'Düsseldorf', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '57076', 'city': 'Siegen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.87481, 'lon': 8.02431}}, {'zip': '76870', 'city': 'Kandel', 'state': 'Rhineland-Palatinate', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.08277, 'lon': 8.1972}}, {'zip': '67059', 'city': 'Ludwigshafen am Rhein', 'state': 'Rhineland-Palatinate', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.48121, 'lon': 8.44641}}, {'zip': '09117', 'city': 'Chemnitz', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.8357, 'lon': 12.92922}}, {'zip': '04229', 'city': 'Leipzig', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '25524', 'city': 'Itzehoe', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 53.92099, 'lon': 9.51529}}, {'zip': '24105', 'city': 'Kiel', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '04600', 'city': 'Altenburg', 'state': 'Thuringia', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.98763, 'lon': 12.43684}}, {'zip': '99096', 'city': 'Erfurt', 'state': 'Thuringia', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.97734, 'lon': 11.03536}}, {'zip': '07747', 'city': 'Jena', 'state': 'Thuringia', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '07646', 'city': 'Stadtroda', 'state': 'Thuringia', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.85684, 'lon': 11.72677}}, {'zip': '10713', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12099', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14169', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '20249', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '22179', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': 'DUBLIN 4', 'city': 'Dublin', 'country': 'Ireland', 'facility': 'Research Site', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': '24127', 'city': 'Bergamo', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'zip': '09126', 'city': 'Cagliari', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 39.23054, 'lon': 9.11917}}, {'zip': '88100', 'city': 'Catanzaro', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}, {'zip': '50134', 'city': 'Florence', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '16153', 'city': 'Genova', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '98121', 'city': 'Messina', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}, {'zip': '20133', 'city': 'Milan', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '80138', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '00133', 'city': 'Roma', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '00152', 'city': 'Roma', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '00189', 'city': 'Roma', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '1261 AN', 'city': 'Blaricum', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.2725, 'lon': 5.24167}}, {'zip': '4818 CK', 'city': 'Breda', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'zip': '1624 NP', 'city': 'Hoorn', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.6425, 'lon': 5.05972}}, {'zip': '4835-044', 'city': 'Guimarães', 'country': 'Portugal', 'facility': 'Research Site', 'geoPoint': {'lat': 41.44443, 'lon': -8.29619}}, {'zip': '2910-446', 'city': 'Setúbal', 'country': 'Portugal', 'facility': 'Research Site', 'geoPoint': {'lat': 38.5244, 'lon': -8.8882}}, {'zip': '11009', 'city': 'Cadiz', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 36.52672, 'lon': -6.2891}}, {'zip': '14011', 'city': 'Córdoba', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '41014', 'city': 'Seville', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '41071', 'city': 'Seville', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '5001', 'city': 'Aarau', 'country': 'Switzerland', 'facility': 'Research Site', 'geoPoint': {'lat': 47.39254, 'lon': 8.04422}}, {'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Research Site', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Research Site', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': '6000', 'city': 'Lucerne', 'country': 'Switzerland', 'facility': 'Research Site', 'geoPoint': {'lat': 47.05048, 'lon': 8.30635}}, {'zip': 'KA128SS', 'city': 'Irvine', 'state': 'Ayrshire', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 55.6194, 'lon': -4.65508}}, {'zip': 'TR13LJ', 'city': 'Truro', 'state': 'Cornwall', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 50.26526, 'lon': -5.05436}}, {'zip': 'NW3 2QG', 'city': 'London', 'state': 'Greater London', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M6 8HD', 'city': 'Salford', 'state': 'Greater Manchester', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.48771, 'lon': -2.29042}}, {'zip': 'IV2 3UJ', 'city': 'Inverness', 'state': 'Highland Region', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 57.47908, 'lon': -4.22398}}, {'zip': 'LE5 4 PW', 'city': 'Leicester', 'state': 'Leicestershire', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'G51 4TF', 'city': 'Glasgow', 'state': 'Strathclyde', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'SA6 6NL', 'city': 'Swansea', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.62079, 'lon': -3.94323}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biogen'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'ipdSharing': 'YES', 'description': "In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biogen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}