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Tolerability and Safety and Health Outcomes in Relapsing Multiple Sclerosis (MS) Patients

Primary Purpose

Relapsing Multiple Sclerosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
FTY720
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing Multiple Sclerosis focused on measuring Relapsing multiple sclerosis, MS, safety, tolerability, health outcomes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-65 years of age, must have relapsing MS

Exclusion Criteria:

  • Patients with a type of MS that is not relapsing
  • Patients with history of chronic immune disease
  • Patients with a history of certain cancers
  • Diabetic patients with certain eye disorders
  • Patients who are on certain immunosuppressive medications or heart medications
  • Patients with certain heart conditions
  • Patients with certain lung conditions

Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

  • Novartis Investigative Site
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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FTY720

Arm Description

Outcomes

Primary Outcome Measures

Evaluate the safety and tolerability profile of FTY720 in patients with relapsing forms of MS

Secondary Outcome Measures

Incidence of macular edema
Incidence of bradyarrhythmic electrocardiograms (ECGs)
Patient reported outcomes indices in multiple sclerosis (PRIMUS), short form health survey-12, and treatment satisfaction questionnaire for medication (TSQM-9)

Full Information

First Posted
May 19, 2010
Last Updated
February 21, 2017
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT01127750
Brief Title
Tolerability and Safety and Health Outcomes in Relapsing Multiple Sclerosis (MS) Patients
Official Title
A 4-month, Open-label, Multi-center Study to Explore Tolerability and Safety and Health Outcomes of FTY720 in Patients With Relapsing Forms of Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis

4. Oversight

5. Study Description

Brief Summary
This study will assess tolerability and safety and health outcomes in relapsing MS patients taking FTY720.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Multiple Sclerosis
Keywords
Relapsing multiple sclerosis, MS, safety, tolerability, health outcomes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2417 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FTY720
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
FTY720
Primary Outcome Measure Information:
Title
Evaluate the safety and tolerability profile of FTY720 in patients with relapsing forms of MS
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Incidence of macular edema
Time Frame
4 months
Title
Incidence of bradyarrhythmic electrocardiograms (ECGs)
Time Frame
4 months
Title
Patient reported outcomes indices in multiple sclerosis (PRIMUS), short form health survey-12, and treatment satisfaction questionnaire for medication (TSQM-9)
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-65 years of age, must have relapsing MS Exclusion Criteria: Patients with a type of MS that is not relapsing Patients with history of chronic immune disease Patients with a history of certain cancers Diabetic patients with certain eye disorders Patients who are on certain immunosuppressive medications or heart medications Patients with certain heart conditions Patients with certain lung conditions Other protocol-defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Box Hill
ZIP/Postal Code
3128
Country
Australia
Facility Name
Novartis Investigative Site
City
Heidelberg
ZIP/Postal Code
3084
Country
Australia
Facility Name
Novartis Investigative Site
City
Kogarah
ZIP/Postal Code
2217
Country
Australia
Facility Name
Novartis Investigative Site
City
Liverpool
ZIP/Postal Code
2170
Country
Australia
Facility Name
Novartis Investigative Site
City
Woodville South
ZIP/Postal Code
5011
Country
Australia
Facility Name
Novartis Investigational Site
City
Linz
ZIP/Postal Code
A-4020
Country
Austria
Facility Name
Novartis Investigational Site
City
Vienna
ZIP/Postal Code
1010
Country
Austria
Facility Name
Novartis Investigational Site
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Novartis Investigational Site
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Novartis Investigational Site
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Novartis Investigational Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Novartis Investigational Site
City
Charleroi
ZIP/Postal Code
6000
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Belgium
Facility Name
Novartis Investigational Site
City
Leuven
ZIP/Postal Code
3000
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Belgium
Facility Name
Novartis Investigational Site
City
Melsbroek
ZIP/Postal Code
1820
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Belgium
Facility Name
Novartis Investigational Site
City
Overpelt
ZIP/Postal Code
3900
Country
Belgium
Facility Name
Novartis Investigational Site
City
Sijsele
ZIP/Postal Code
8340
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Belgium
Facility Name
Novartis Investigational Site
City
Tinlot
ZIP/Postal Code
4557
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Belgium
Facility Name
Novartis Investigational Site
City
Wilrijk
ZIP/Postal Code
2610
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Belgium
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Novartis Investigational Site
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Montreal
ZIP/Postal Code
H2L 4M1
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Canada
Facility Name
Novartis Investigational Site
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Quebec
ZIP/Postal Code
G1J 1Z4
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Canada
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Novartis Investigational Site
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Victoria
ZIP/Postal Code
V8R 1J8
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Canada
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Novartis Investigational Site
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Praha 2
ZIP/Postal Code
128 02
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Czech Republic
Facility Name
Novartis Investigational Site
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Teplice
ZIP/Postal Code
415 29
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Czech Republic
Facility Name
Novartis Investigational Site
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Copenhagen
ZIP/Postal Code
2100
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Denmark
Facility Name
Novartis Investigational Site
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Århus
ZIP/Postal Code
DK-8000
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Denmark
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Novartis Investigational Site
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Helsinki
ZIP/Postal Code
00100
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Finland
Facility Name
Novartis Investigational Site
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Turku
ZIP/Postal Code
20520
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Finland
Facility Name
Novartis Investigational Site
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Aachen
ZIP/Postal Code
52062
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Germany
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Novartis Investigative Site
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Aachen
ZIP/Postal Code
52062
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Germany
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Novartis Investigational Site
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Aalen
ZIP/Postal Code
73430
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Germany
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Novartis Investigational Site
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Abensberg
ZIP/Postal Code
93326
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Germany
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Novartis Investigational Site
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Achim
ZIP/Postal Code
28832
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Germany
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Novartis Investigational Site
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Alzenau
ZIP/Postal Code
63755
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Germany
Facility Name
Novartis Investigational Site
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Aschaffenburg
ZIP/Postal Code
63739
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Germany
Facility Name
Novartis Investigational Site
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Attenberg
ZIP/Postal Code
04600
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Germany
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Novartis Investigational Site
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Augsburg
ZIP/Postal Code
86156
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Germany
Facility Name
Novartis Investigational Site
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Bad Honnef
ZIP/Postal Code
53604
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Germany
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Novartis Investigational Site
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Bad Krozingen
ZIP/Postal Code
79189
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Germany
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Novartis Investigative Site
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Bad Mergentheim
ZIP/Postal Code
97980
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Germany
Facility Name
Novartis Investigational Site
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Bad Neustadt / Saale
ZIP/Postal Code
97616
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Germany
Facility Name
Novartis Investigational Site
City
Bamberg
ZIP/Postal Code
96047
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Germany
Facility Name
Novartis Investigational Site
City
Bamberg
ZIP/Postal Code
96049
Country
Germany
Facility Name
Novartis Investigative Site
City
Bayreuth
ZIP/Postal Code
95445
Country
Germany
Facility Name
Novartis Investigative Site
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Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10178
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10625
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10713
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10785
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10961
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
12103
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
12163
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
12351
Country
Germany
Facility Name
Novarris Investigative Site
City
Berlin
ZIP/Postal Code
13088
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Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13347
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Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13439
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Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13507
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
14163
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Germany
Facility Name
Novartis Investigative Site
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Bielefeld
ZIP/Postal Code
33602
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Germany
Facility Name
Novartis Investigative Site
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Bielefeld
ZIP/Postal Code
33617
Country
Germany
Facility Name
Novartis Investigative Site
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Bielefeld
ZIP/Postal Code
33647
Country
Germany
Facility Name
Novartis Investigative Site
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Boblingen
ZIP/Postal Code
71034
Country
Germany
Facility Name
Novartis Investigational Site
City
Bochum
ZIP/Postal Code
44787
Country
Germany
Facility Name
Novartis Investigative Site
City
Bochum
ZIP/Postal Code
44789
Country
Germany
Facility Name
Novartis Investigational Site
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Novaratis Investigative Site
City
Bochum
ZIP/Postal Code
44892
Country
Germany
Facility Name
Novartis Investigational Site
City
Bogen
ZIP/Postal Code
94327
Country
Germany
Facility Name
Novartis Investigative Site
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Novartis Investigative Site
City
Bonn
ZIP/Postal Code
53117
Country
Germany
Facility Name
Novartis Investigational Site
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Braunschweig
ZIP/Postal Code
38126
Country
Germany
Facility Name
Novartis Investigational Site
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Buchholz
ZIP/Postal Code
21244
Country
Germany
Facility Name
Novartis Investigational Site
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Chemnitz
ZIP/Postal Code
09117
Country
Germany
Facility Name
Novartis Investigational Site
City
Dillingen
ZIP/Postal Code
89407
Country
Germany
Facility Name
Novartis Investigative Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Novartis Investigative Site
City
Düsseldorf
ZIP/Postal Code
40211
Country
Germany
Facility Name
Novartis Investigational Site
City
Eisenach
ZIP/Postal Code
99817
Country
Germany
Facility Name
Novartis Investigative Site
City
Emden
ZIP/Postal Code
26721
Country
Germany
Facility Name
Novartis Investigational Site
City
Emmendingen
ZIP/Postal Code
79312
Country
Germany
Facility Name
Novartis Investigative Site
City
Erbach
ZIP/Postal Code
64711
Country
Germany
Facility Name
Novartis Investigational Site
City
Erfurt
ZIP/Postal Code
99089
Country
Germany
Facility Name
Novartis Investigational Site
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Novartis Investigative Site
City
Essen
ZIP/Postal Code
103949
Country
Germany
Facility Name
Novartis Investigational Site
City
Essen
ZIP/Postal Code
45131
Country
Germany
Facility Name
Novartis Investigative Site
City
Essen
ZIP/Postal Code
45138
Country
Germany
Facility Name
Novartis Investigational Site
City
Frankfurt
ZIP/Postal Code
60488
Country
Germany
Facility Name
Novartis Investigational Site
City
Frankfurt
ZIP/Postal Code
60528
Country
Germany
Facility Name
Novartis Investigative Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Novartis Investigational Site
City
Greifswald
ZIP/Postal Code
17487
Country
Germany
Facility Name
Novartis Investigational Site
City
Grevenbroich
ZIP/Postal Code
41515
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
20249
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
20354
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
22083
Country
Germany
Facility Name
Novartis Investigational Site
City
Hamburg
ZIP/Postal Code
22087
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
22179
Country
Germany
Facility Name
Novartis Investigational Site
City
Hamburg
ZIP/Postal Code
22291
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
22297
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
22523
Country
Germany
Facility Name
Novartis Investigative Site
City
Hannover
ZIP/Postal Code
30161
Country
Germany
Facility Name
Novartis Investigative Site
City
Hannover
ZIP/Postal Code
30559
Country
Germany
Facility Name
Novartis Investigative Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Novartis Investigative Site
City
Heidelburg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Novartis Investigational Site
City
Herborn
ZIP/Postal Code
35745
Country
Germany
Facility Name
Novartis Investigational Site
City
Herdecke
ZIP/Postal Code
58313
Country
Germany
Facility Name
Novartis Investigational Site
City
Herne
ZIP/Postal Code
44651
Country
Germany
Facility Name
Novartis Investigational Site
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Facility Name
Novartis Investigational Site
City
Itzehoe
ZIP/Postal Code
25524
Country
Germany
Facility Name
Novartis Investigational Site
City
Jena
ZIP/Postal Code
07740
Country
Germany
Facility Name
Novartis Investigational Site
City
Jena
ZIP/Postal Code
07743
Country
Germany
Facility Name
Novartis Investigational Site
City
Kaltenkirchen
ZIP/Postal Code
24568
Country
Germany
Facility Name
Novartis Investigative Site
City
Kandel
ZIP/Postal Code
76870
Country
Germany
Facility Name
Novartis Investigational Site
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
Facility Name
Novartis Investigational Site
City
Karlstadt
ZIP/Postal Code
97753
Country
Germany
Facility Name
Novartis Investigational Site
City
Kassel
ZIP/Postal Code
34121
Country
Germany
Facility Name
Novartis Investigative Site
City
Koeln
ZIP/Postal Code
51109
Country
Germany
Facility Name
Novartis Investigative Site
City
Koln
ZIP/Postal Code
50924
Country
Germany
Facility Name
Novartis Investigative Site
City
Koln
ZIP/Postal Code
50935
Country
Germany
Facility Name
Neuroscience Research of the Berkshires
City
Krefeld
ZIP/Postal Code
47805
Country
Germany
Facility Name
Novartis Investigational Site
City
Landshut
ZIP/Postal Code
84028
Country
Germany
Facility Name
Novartis Investigational Site
City
Lappersdorf
ZIP/Postal Code
93138
Country
Germany
Facility Name
Novartis Investigational Site
City
Leipzig
ZIP/Postal Code
04275
Country
Germany
Facility Name
Novartis Investigative Site
City
Lengerich
ZIP/Postal Code
49525
Country
Germany
Facility Name
Novartis Investigational Site
City
Lohr am Main
ZIP/Postal Code
79816
Country
Germany
Facility Name
Novartis Investigational Site
City
Ludwigshafen
ZIP/Postal Code
67059
Country
Germany
Facility Name
Novartis Investigative Site
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Facility Name
Novartis Investigative Site
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Novartis Investigative Site
City
Mainz
ZIP/Postal Code
55101
Country
Germany
Facility Name
Novartis Investigational Site
City
Mannheim
ZIP/Postal Code
68159
Country
Germany
Facility Name
Novartis Investigational Site
City
Marburg
ZIP/Postal Code
35033
Country
Germany
Facility Name
Novartis Investigational Site
City
Marburg
ZIP/Postal Code
35039
Country
Germany
Facility Name
Novartis Investigational Site
City
Mittweida
ZIP/Postal Code
09648
Country
Germany
Facility Name
Novartis Investigational Site
City
Muenchen
ZIP/Postal Code
80331
Country
Germany
Facility Name
Novartis Investigational Site
City
Muenchen
ZIP/Postal Code
81377
Country
Germany
Facility Name
Novartis Investigational Site
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Novartis Investigational Site
City
Munchen
ZIP/Postal Code
81829
Country
Germany
Facility Name
Novartis Investigational Site
City
Mönchengladbach
ZIP/Postal Code
41063
Country
Germany
Facility Name
Novartis Investigational Site
City
München
ZIP/Postal Code
81241
Country
Germany
Facility Name
Novartis Investigational Site
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Novartis Investigative Site
City
München
ZIP/Postal Code
81825
Country
Germany
Facility Name
Novartis Investigational Site
City
Nagold
ZIP/Postal Code
72202
Country
Germany
Facility Name
Novartis Investigational Site
City
Neu-Ulm
ZIP/Postal Code
89231
Country
Germany
Facility Name
Novartis Investigational Site
City
Neuburg
ZIP/Postal Code
86633
Country
Germany
Facility Name
Novartis Investigational Site
City
Neuruppin
ZIP/Postal Code
16816
Country
Germany
Facility Name
Novartis Investigational Site
City
Nurnberg
ZIP/Postal Code
90461
Country
Germany
Facility Name
Novartis Investigative Site
City
Oldenburg
ZIP/Postal Code
26122
Country
Germany
Facility Name
Novartis Investigational Site
City
Osnabrück
ZIP/Postal Code
49076
Country
Germany
Facility Name
Novartis Investigational Site
City
Ostfildern
ZIP/Postal Code
73760
Country
Germany
Facility Name
Novartis Investigational Site
City
Pforzheim
ZIP/Postal Code
75172
Country
Germany
Facility Name
Novartis Investigational Site
City
Potsdam
ZIP/Postal Code
14467
Country
Germany
Facility Name
Novartis Investigational Site
City
Potsdam
ZIP/Postal Code
14471
Country
Germany
Facility Name
Novartis Investigational Site
City
Prien
ZIP/Postal Code
83209
Country
Germany
Facility Name
Novartis Investigational Site
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Novartis Investigational Site
City
Rostock
ZIP/Postal Code
18147
Country
Germany
Facility Name
Novartis Investigative Site
City
Rudersdorf
ZIP/Postal Code
15562
Country
Germany
Facility Name
Novartis Investigational Site
City
Rösrath
ZIP/Postal Code
51503
Country
Germany
Facility Name
Novartis Investigational Site
City
Schwarzenbruck
ZIP/Postal Code
90592
Country
Germany
Facility Name
Novartis Investigative Site
City
Schwendi
ZIP/Postal Code
88477
Country
Germany
Facility Name
Novartis Investigative Site
City
Siegen
ZIP/Postal Code
57072
Country
Germany
Facility Name
Novartis Investigational Site
City
Sigmaringen
ZIP/Postal Code
72488
Country
Germany
Facility Name
Novartis Investigational Site
City
Sinsheim
ZIP/Postal Code
74889
Country
Germany
Facility Name
Novartis Investigative Site
City
Stade
ZIP/Postal Code
21682
Country
Germany
Facility Name
Novartis Investigational Site
City
Stuttgart
ZIP/Postal Code
70176
Country
Germany
Facility Name
Novartis Investigative Site
City
Stuttgart
ZIP/Postal Code
70178
Country
Germany
Facility Name
Novartis Investigative Site
City
Stuttgart
ZIP/Postal Code
70182
Country
Germany
Facility Name
Novartis Investigational Site
City
Stuttgart
ZIP/Postal Code
70191
Country
Germany
Facility Name
Novartis Investigational Site
City
Teupitz
ZIP/Postal Code
15755
Country
Germany
Facility Name
Novartis Investigational Site
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Novartis Investigative Site
City
Ulm
ZIP/Postal Code
89073
Country
Germany
Facility Name
Novartis Investigational Site
City
Unterhaching
ZIP/Postal Code
82008
Country
Germany
Facility Name
Novartis Investigational Site
City
Wendlingen
ZIP/Postal Code
73240
Country
Germany
Facility Name
Novartis Investigational Site
City
Wermsdorf
ZIP/Postal Code
04779
Country
Germany
Facility Name
Novartis Investigational Site
City
Westerstede
ZIP/Postal Code
26655
Country
Germany
Facility Name
Novartis Investigational Site
City
Wiesbaden
ZIP/Postal Code
65183
Country
Germany
Facility Name
Novartis Investigative Site
City
Wiesbaden
ZIP/Postal Code
65191
Country
Germany
Facility Name
Novartis Investigational Site
City
Wuppertal
ZIP/Postal Code
42283
Country
Germany
Facility Name
Novartis Investigational Site
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Novartis Investigational Site
City
Alexandroupolis
ZIP/Postal Code
68100
Country
Greece
Facility Name
Novartis Investigational Site
City
Athens
ZIP/Postal Code
10675
Country
Greece
Facility Name
Novartis Investigational Site
City
Athens
ZIP/Postal Code
15123
Country
Greece
Facility Name
Novartis Investigational Site
City
Thessaloniki
ZIP/Postal Code
57001
Country
Greece
Facility Name
Novartis Investigational Site
City
Thessaloniki
ZIP/Postal Code
GR 570 10
Country
Greece
Facility Name
Novartis Investigational Site
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Novartis Investigational Site
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
Facility Name
Novartis Investigational Site
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
Facility Name
Novartis Investigational Site
City
Pecs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Novartis Investigational Site
City
Szeged
ZIP/Postal Code
H-6725
Country
Hungary
Facility Name
Novartis Investigational Site
City
Cork
Country
Ireland
Facility Name
Novartis Investigational Site
City
Dublin 4
Country
Ireland
Facility Name
Novartis Investigational Site
City
Dublin 9
Country
Ireland
Facility Name
Novartis Investigative Site
City
Acquaviva delle Fonti
ZIP/Postal Code
70021
Country
Italy
Facility Name
Novartis Investigative SIte
City
Asti
ZIP/Postal Code
14100
Country
Italy
Facility Name
Novartis Investigative Site
City
Bergamo
ZIP/Postal Code
24128
Country
Italy
Facility Name
Novartis Investigative Site
City
Bologna
ZIP/Postal Code
40139
Country
Italy
Facility Name
Novartis Investigative Site
City
Cagliari
ZIP/Postal Code
09126
Country
Italy
Facility Name
Novartis Investigative Site
City
Catania
ZIP/Postal Code
95122
Country
Italy
Facility Name
Novartis Investigational Site
City
Foggia
ZIP/Postal Code
71100
Country
Italy
Facility Name
Novartis Investigative Site
City
Foggia
ZIP/Postal Code
71100
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Novartis Investigative Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Novartis Investigational Site
City
Napoli
ZIP/Postal Code
80132
Country
Italy
Facility Name
Novartis Investigational Site
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Facility Name
Novartis Investigative Site
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
Novartis Investigative Site
City
Pozzilli
ZIP/Postal Code
86077
Country
Italy
Facility Name
Novartis Investigative Site
City
Ravenna
ZIP/Postal Code
48100
Country
Italy
Facility Name
Novartis Investigational Site
City
Roma
ZIP/Postal Code
00135
Country
Italy
Facility Name
Novartis Investigational Site
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Novartis Investigational Site
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Novartis Investigational Site
City
Roma
ZIP/Postal Code
00185
Country
Italy
Facility Name
Novartis Investigative Site
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Novartis Investigative Site
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Novartis Investigative Site
City
Verona
ZIP/Postal Code
37134
Country
Italy
Facility Name
Novartis Investigative Site
City
Vicenza
ZIP/Postal Code
36100
Country
Italy
Facility Name
Novartis Investigative Site
City
Viterbo
ZIP/Postal Code
01100
Country
Italy
Facility Name
Novartis Investigational Site
City
Amsterdam
ZIP/Postal Code
1061 AE
Country
Netherlands
Facility Name
Novartis Investigational Site
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Novartis Investigational Site
City
Blaricum
ZIP/Postal Code
1261 AN
Country
Netherlands
Facility Name
Novartis Investigational Site
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
Novartis Investigational Site
City
Enschede
ZIP/Postal Code
7513 ER
Country
Netherlands
Facility Name
Novartis Investigational Site
City
Gouda
ZIP/Postal Code
2800 BB
Country
Netherlands
Facility Name
Novartis Investigational Site
City
Tilburg
ZIP/Postal Code
5022 GC
Country
Netherlands
Facility Name
Novartis Investigational Site
City
Lillehammer
ZIP/Postal Code
2609
Country
Norway
Facility Name
Novartis Investigational Site
City
Molde
ZIP/Postal Code
6407
Country
Norway
Facility Name
Novartis Investigational Site
City
Stavanger
ZIP/Postal Code
4868
Country
Norway
Facility Name
Novartis Investigational Site
City
Bydgoszcz
ZIP/Postal Code
85-681
Country
Poland
Facility Name
Novartis Investigational Site
City
Katowice
ZIP/Postal Code
40-594
Country
Poland
Facility Name
Novartis Investigational Site
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Novartis Investigational Site
City
Amadora
ZIP/Postal Code
2720-276
Country
Portugal
Facility Name
Novartis Investigational Site
City
Coimbra
ZIP/Postal Code
3041-853
Country
Portugal
Facility Name
Novartis Investigational Site
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Novartis Investigational Site
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Novartis Investigational Site
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Novartis Investigational Site
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Novartis Investigational Site
City
Kazan
ZIP/Postal Code
420021
Country
Russian Federation
Facility Name
Novartis Investigational Site
City
Kazan
ZIP/Postal Code
420097
Country
Russian Federation
Facility Name
Novartis Investigational Site
City
Moscow
ZIP/Postal Code
121356
Country
Russian Federation
Facility Name
Novartis Investigational Site
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
Novartis Investigational Site
City
Moscow
ZIP/Postal Code
127018
Country
Russian Federation
Facility Name
Novartis Investigational Site
City
Nizhny Novgorod
ZIP/Postal Code
603018
Country
Russian Federation
Facility Name
Novartis Investigational Site
City
Nizhny Novgorod
ZIP/Postal Code
603155
Country
Russian Federation
Facility Name
Novartis Investigational Site
City
S.-Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
Novartis Investigational Site
City
Samara
ZIP/Postal Code
443095
Country
Russian Federation
Facility Name
Novartis Investigational Site
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
Novartis Investigational Site
City
St. Petersburg
ZIP/Postal Code
197376
Country
Russian Federation
Facility Name
Novartis Investigational Site
City
Banska Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
Facility Name
Novartis Investigational Site
City
Bratislava
ZIP/Postal Code
82606
Country
Slovakia
Facility Name
Novartis Investigational Site
City
Trnava
ZIP/Postal Code
917 75
Country
Slovakia
Facility Name
Novartis Investigational Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Novartis Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Novartis Investigational Site
City
El Palmar
ZIP/Postal Code
30120
Country
Spain
Facility Name
Novartis Investigational Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Novartis Investigational Site
City
Madrid
Country
Spain
Facility Name
Novartis Investigational Site
City
San Sebastian
ZIP/Postal Code
20014
Country
Spain
Facility Name
Novartis Investigational Site
City
Santa Cruz de Tenerife
ZIP/Postal Code
38009
Country
Spain
Facility Name
Novartis Investigational Site
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Novartis Investigational Site
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Novartis Investigational Site
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Novartis Investigational Site
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Novartis Investigational Site
City
Umea
ZIP/Postal Code
901 85
Country
Sweden
Facility Name
Novartis Investigational Site
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
Facility Name
Novartis Investigational Site
City
Carouge
ZIP/Postal Code
1227
Country
Switzerland
Facility Name
Novartis Investigational Site
City
Geneve
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Novartis Investigational Site
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Novartis Investigational Site
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland
Facility Name
Novartis Investigational Site
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Novartis Investigational Site
City
Zuerich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Novartis Investigational Site
City
Antalya
ZIP/Postal Code
07070
Country
Turkey
Facility Name
Novartis Investigational Site
City
Gaziantep
ZIP/Postal Code
27070
Country
Turkey
Facility Name
Novartis Investigational Site
City
Istanbul
ZIP/Postal Code
34096
Country
Turkey
Facility Name
Novartis Investigational Site
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Novartis Investigational Site
City
Samsun
Country
Turkey
Facility Name
Novartis Investigational Site
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Facility Name
Novartis Investigational Site
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Novartis Investigational Site
City
Brighton
ZIP/Postal Code
BN2 2BE
Country
United Kingdom
Facility Name
Novartis Investigational Site
City
Dundee
Country
United Kingdom
Facility Name
Novartis Investigational Site
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Novartis Investigational Site
City
Essex
ZIP/Postal Code
RM7 0BE
Country
United Kingdom
Facility Name
Novartis Investigational Site
City
Great Yarmouth
ZIP/Postal Code
NR31 6LA
Country
United Kingdom
Facility Name
Novartis Investigational Site
City
Headington
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Novartis Investigational Site
City
Liverpool
ZIP/Postal Code
L9 7LJ
Country
United Kingdom
Facility Name
Novartis Investigational Site
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Novartis Investigational Site
City
London
ZIP/Postal Code
W8 6RF
Country
United Kingdom
Facility Name
Novartis Investigational Site
City
Middlesborough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Facility Name
Novartis Investigational Site
City
Newcastle Upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Novartis Investigational Site
City
Northampton
ZIP/Postal Code
NN1 5BD
Country
United Kingdom
Facility Name
Novartis Investigational Site
City
Norwick
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
Novartis Investigational Site
City
Poole
ZIP/Postal Code
BH15 2JB
Country
United Kingdom
Facility Name
Novartis Investigational Site
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
Novartis Investigational Site
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
Novartis Investigational Site
City
Stoke on Trent
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
Facility Name
Novartis Investigational Site
City
Swindon
ZIP/Postal Code
SN3 6BB
Country
United Kingdom
Facility Name
Novartis Investigational Site
City
Truro
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24221641
Citation
Gold R, Comi G, Palace J, Siever A, Gottschalk R, Bijarnia M, von Rosenstiel P, Tomic D, Kappos L; FIRST Study Investigators. Assessment of cardiac safety during fingolimod treatment initiation in a real-world relapsing multiple sclerosis population: a phase 3b, open-label study. J Neurol. 2014 Feb;261(2):267-76. doi: 10.1007/s00415-013-7115-8. Epub 2013 Nov 13.
Results Reference
result

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Tolerability and Safety and Health Outcomes in Relapsing Multiple Sclerosis (MS) Patients

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