STudy to vAlidate telemetRic ECG Systems for firsT Dose Administration of Fingolimod (START) (START)

A 1-week, Open-label, Multi-center Study to Explore Conduction Abnormalities During First Dose Administration of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis

This study evaluated bradycardiac events during first dose observation of fingolimod in MS patients.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: FTY720

• Study Type: Interventional
• Enrollment (Actual): 6998
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany, 52074
    • Novartis Investigative Site
  • Aachen, Germany, 52062
    • Novartis Investigative Site
  • Aalen, Germany, 73430
    • Novartis Investigative Site
  • Aalen-Wasseralfingen, Germany, 73433
    • Novartis Investigative Site
  • Abensberg, Germany, 93326
    • Novartis Investigative Site
  • Achim, Germany, 28832
    • Novartis Investigative Site
  • Aichach, Germany, 86551
    • Novartis Investigative Site
  • Altenburg, Germany, 04600
    • Novartis Investigative Site
  • Altenholz-Stift, Germany, 24161
    • Novartis Investigative Site
  • Alzenau, Germany, 63755
    • Novartis Investigative Site
  • Andernach, Germany, 56626
    • Novartis Investigative Site
  • Asbach, Germany, 53567
    • Novartis Investigative Site
  • Aschaffenburg, Germany, 63739
    • Novartis Investigative Site
  • Augsburg, Germany, 86179
    • Novartis Investigative Site
  • Bad Berka, Germany, 99437
    • Novartis Investigative Site
  • Bad Hersfeld, Germany, 36251
    • Novartis Investigative Site
  • Bad Homburg, Germany, 61348
    • Novartis Investigative Site
  • Bad Honnef, Germany, 53604
    • Novartis Investigative Site
  • Bad Krozingen, Germany, 79189
    • Novartis Investigative Site
  • Bad Mergentheim, Germany, 97980
    • Novartis Investigative Site
  • Bad Saarow, Germany, 15526
    • Novartis Investigative Site
  • Bad Wildbad, Germany, 75323
    • Novartis Investigative Site
  • Bamberg, Germany, 96052
    • Novartis Investigative Site
  • Bayreuth, Germany, 95445
    • Novartis Investigative Site
  • Berg, Germany, 82335
    • Novartis Investigative Site
  • Bergisch Gladbach, Germany, 51429
    • Novartis Investigative Site
  • Berlin, Germany, 10365
    • Novartis Investigative Site
  • Berlin, Germany, 10713
    • Novartis Investigative Site
  • Berlin, Germany, 14169
    • Novartis Investigative Site
  • Berlin, Germany, 13353
    • Novartis Investigative Site
  • Berlin, Germany, 120999
    • Novartis Investigative Site
  • Berlin, Germany, 12101
    • Novartis Investigative Site
  • Berlin, Germany, 12163
    • Novartis Investigative Site
  • Berlin, Germany, 13347
    • Novartis Investigative Site
  • Berlin, Germany, 14059
    • Novartis Investigative Site
  • Berlin, Germany, 10178
    • Novartis Investigative Site
  • Berlin, Germany, 12351
    • Novartis Investigative Site
  • Berlin, Germany, 13507
    • Novartis Investigative Site
  • Berlin, Germany, 12621
    • Novartis Investigative Site
  • Berlin, Germany, 14163
    • Novartis Investigative Site
  • Berlin, Germany, 10437
    • Novartis Investigative Site
  • Berlin, Germany, 13465
    • Novartis Investigative Site
  • Berlin, Germany, 12587
    • Novartis Investigative Site
  • Bielefeld, Germany, 33647
    • Novartis Investigative Site
  • Bielefeld, Germany, 33602
    • Novartis Investigative Site
  • Boblingen, Germany, 71032
    • Novartis Investigative Site
  • Bochum, Germany, 44791
    • Novartis Investigative Site
  • Bochum, Germany, 44787
    • Novartis Investigative Site
  • Bochum, Germany, 44789
    • Novartis Investigative Site
  • Bochum, Germany, 44795
    • Novartis Investigative Site
  • Bochum, Germany, 44869
    • Novartis Investigative Site
  • Bogen, Germany, 94327
    • Novartis Investigative Site
  • Bonn, Germany, 53111
    • Novartis Investigative Site
  • Borna, Germany, 04552
    • Novartis Investigative Site
  • Bottrop, Germany, 46236
    • Novartis Investigative Site
  • Braunschweig, Germany, 38114
    • Novartis Investigative Site
  • Braunschweig, Germany, 38100
    • Novartis Investigative Site
  • Bremen, Germany, 28755
    • Novartis Investigative Site
  • Bruchsal, Germany, 76646
    • Novartis Investigative Site
  • Buchholz, Germany, 21244
    • Novartis Investigative Site
  • Buchholz in der Nordheide, Germany, 21244
    • Novartis Investigative Site
  • Butzbach, Germany, 35510
    • Novartis Investigative Site
  • Celle, Germany, 29223
    • Novartis Investigative Site
  • Chemnitz, Germany, 09117
    • Novartis Investigative Site
  • Delbrueck, Germany, 33129
    • Novartis Investigative Site
  • Dessau, Germany, 06846
    • Novartis Investigative Site
  • Dillingen, Germany, 66763
    • Novartis Investigative Site
  • Dillingen, Germany, 89407
    • Novartis Investigative Site
  • Dortmund, Germany, 44137
    • Novartis Investigative Site
  • Dortmund, Germany, 44135
    • Novartis Investigative Site
  • Dresden, Germany, 01307
    • Novartis Investigative Site
  • Dresden, Germany, 01067
    • Novartis Investigative Site
  • Duesseldorf, Germany, 40225
    • Novartis Investigative Site
  • Duesseldorf, Germany, 40479
    • Novartis Investigative Site
  • Düren, Germany, 52351
    • Novartis Investigative Site
  • Düsseldorf, Germany, 40211
    • Novartis Investigative Site
  • Düsseldorf, Germany, 40625
    • Novartis Investigative Site
  • Eberswalde, Germany, 16225
    • Novartis Investigative Site
  • Eisenach, Germany, 99817
    • Novartis Investigative Site
  • Eltville, Germany, 65343
    • Novartis Investigative Site
  • Emden, Germany, 26721
    • Novartis Investigative Site
  • Emmendingen, Germany, 79312
    • Novartis Investigative Site
  • Erbach, Germany, 64711
    • Novartis Investigative Site
  • Erfurt, Germany, 99089
    • Novartis Investigative Site
  • Erfurt, Germany, 99096
    • Novartis Investigative Site
  • Erlangen, Germany, 91054
    • Novartis Investigative Site
  • Eschwege, Germany, 37269
    • Novartis Investigative Site
  • Essen, Germany, 45147
    • Novartis Investigative Site
  • Essen, Germany, 45138
    • Novartis Investigative Site
  • Essen, Germany, 45131
    • Novartis Investigative Site
  • Essen, Germany, 45257
    • Novartis Investigative Site
  • Frankfurt, Germany, 60590
    • Novartis Investigative Site
  • Frankfurt, Germany, 60313
    • Novartis Investigative Site
  • Frankfurt am Main, Germany, 60313
    • Novartis Investigative Site
  • Frankfurt am Main, Germany, 60594
    • Novartis Investigative Site
  • Freiburg, Germany, 79098
    • Novartis Investigative Site
  • Freiburg, Germany, 79106
    • Novartis Investigative Site
  • Friedrichshafen, Germany, 88048
    • Novartis Investigative Site
  • Fulda, Germany, 36043
    • Novartis Investigative Site
  • Fulda, Germany, 36037
    • Novartis Investigative Site
  • Geldern, Germany, 47608
    • Novartis Investigative Site
  • Gelnhausen, Germany, 63571
    • Novartis Investigative Site
  • Gelsenkirchen, Germany, 45879
    • Novartis Investigative Site
  • Gilching, Germany, 82205
    • Novartis Investigative Site
  • Gladenbach, Germany, 35075
    • Novartis Investigative Site
  • Gottingen, Germany, 37075
    • Novartis Investigative Site
  • Greifswald, Germany, 17475
    • Novartis Investigative Site
  • Grevenbroich, Germany, 41515
    • Novartis Investigative Site
  • Griesheim, Germany, 64347
    • Novartis Investigative Site
  • Guetersloh, Germany, 33332
    • Novartis Investigative Site
  • Gummersbach, Germany, 51643
    • Novartis Investigative Site
  • Göttingen, Germany, 37073
    • Novartis Investigative Site
  • Haar, Germany, 85540
    • Novartis Investigative Site
  • Hagen, Germany, 58095
    • Novartis Investigative Site
  • Halle (Saale), Germany, 06120
    • Novartis Investigative Site
  • Halle S, Germany, 06120
    • Novartis Investigative Site
  • Hamburg, Germany, 20354
    • Novartis Investigative Site
  • Hamburg, Germany, 20099
    • Novartis Investigative Site
  • Hamburg, Germany, 22083
    • Novartis Investigative Site
  • Hamburg, Germany, 20249
    • Novartis Investigative Site
  • Hamburg, Germany, 22179
    • Novartis Investigative Site
  • Hamburg, Germany, 22297
    • Novartis Investigative Site
  • Hamburg, Germany, 22523
    • Novartis Investigative Site
  • Hannover, Germany, 30625
    • Novartis Investigative Site
  • Hannover, Germany, 30161
    • Novartis Investigative Site
  • Hannover, Germany, 30171
    • Novartis Investigative Site
  • Heidelberg, Germany, 69120
    • Novartis Investigative Site
  • Heidenheim, Germany, 89518
    • Novartis Investigative Site
  • Herdecke, Germany, 58313
    • Novartis Investigative Site
  • Herford, Germany, 32049
    • Novartis Investigative Site
  • Herford, Germany, 32052
    • Novartis Investigative Site
  • Hildesheim, Germany, 31134
    • Novartis Investigative Site
  • Homburg, Germany, 66421
    • Novartis Investigative Site
  • Hoppegarten, Germany, 15366
    • Novartis Investigative Site
  • Ibbenbueren, Germany, 49477
    • Novartis Investigative Site
  • Idar-Oberstein, Germany, 55743
    • Novartis Investigative Site
  • Isselburg-Anholt, Germany, 46419
    • Novartis Investigative Site
  • Itzehoe, Germany, 25524
    • Novartis Investigative Site
  • Jena, Germany, 07740
    • Novartis Investigative Site
  • Jena, Germany, 07743
    • Novartis Investigative Site
  • Juelich, Germany, 52428
    • Novartis Investigative Site
  • Kaiserslautern, Germany, 67655
    • Novartis Investigative Site
  • Kaltenkirchen, Germany, 24568
    • Novartis Investigative Site
  • Kandel, Germany, 76870
    • Novartis Investigative Site
  • Karlstadt, Germany, 97753
    • Novartis Investigative Site
  • Kassel, Germany, 34121
    • Novartis Investigative Site
  • Kiel, Germany, 24105
    • Novartis Investigative Site
  • Klingenmünster, Germany, 76889
    • Novartis Investigative Site
  • Koeln, Germany, 51109
    • Novartis Investigative Site
  • Koeln-Longerich, Germany, 50737
    • Novartis Investigative Site
  • Koln, Germany, 50935
    • Novartis Investigative Site
  • Korbach, Germany, 34497
    • Novartis Investigative Site
  • Krefeld, Germany, 47800
    • Novartis Investigative Site
  • Krefeld, Germany, 47805
    • Novartis Investigative Site
  • Köln, Germany, 50674
    • Novartis Investigative Site
  • Königsbrück, Germany, 01936
    • Novartis Investigative Site
  • Landshut, Germany, 84028
    • Novartis Investigative Site
  • Lappersdorf, Germany, 93138
    • Novartis Investigative Site
  • Leipzig, Germany, 04103
    • Novartis Investigative Site
  • Leipzig, Germany, 04275
    • Novartis Investigative Site
  • Leipzig, Germany, 04157
    • Novartis Investigative Site
  • Leipzig, Germany, 04299
    • Novartis Investigative Site
  • Leverkusen, Germany, 51375
    • Novartis Investigative Site
  • Lohr am Main, Germany, 79816
    • Novartis Investigative Site
  • Lubeck, Germany, 23538
    • Novartis Investigative Site
  • Ludwigshafen, Germany, 67063
    • Novartis Investigative Site
  • Ludwigshafen, Germany, 67059
    • Novartis Investigative Site
  • Luenen, Germany, 44534
    • Novartis Investigative Site
  • Luneburg, Germany, 21335
    • Novartis Investigative Site
  • Lutherstadt Eisleben, Germany, 06295
    • Novartis Investigative Site
  • Magdeburg, Germany, 39120
    • Novartis Investigative Site
  • Magdeburg, Germany, 39104
    • Novartis Investigative Site
  • Mannheim, Germany, 66163
    • Novartis Investigative Site
  • Mannheim, Germany, 68159
    • Novartis Investigative Site
  • Mannheim, Germany, 68161
    • Novartis Investigative Site
  • Marburg, Germany, 35039
    • Novartis Investigative Site
  • Meisenheim, Germany, 55590
    • Novartis Investigative Site
  • Minden, Germany, 32423
    • Novartis Investigative Site
  • Minden, Germany, 32429
    • Novartis Investigative Site
  • Mittweida, Germany, 09648
    • Novartis Investigative Site
  • Mosbach, Germany, 74821
    • Novartis Investigative Site
  • Muenchen, Germany, 81675
    • Novartis Investigative Site
  • Muenchen, Germany, 80331
    • Novartis Investigative Site
  • Muenster, Germany, 48149
    • Novartis Investigative Site
  • Mönchengladbach, Germany, 41239
    • Novartis Investigative Site
  • Mönchengladbach, Germany, 41063
    • Novartis Investigative Site
  • Mülheim, Germany, 45481
    • Novartis Investigative Site
  • München, Germany, 81829
    • Novartis Investigative Site
  • Münster, Germany, 48147
    • Novartis Investigative Site
  • Nagold, Germany, 72202
    • Novartis Investigative Site
  • Naumburg, Germany, 06618
    • Novartis Investigative Site
  • Neu-Ulm, Germany, 89231
    • Novartis Investigative Site
  • Neuburg an der Donau, Germany, 86633
    • Novartis Investigative Site
  • Neuruppin, Germany, 16816
    • Novartis Investigative Site
  • Neusaess, Germany, 86356
    • Novartis Investigative Site
  • Neustadt An Der Weinstraße, Germany, 67433
    • Novartis Investigative Site
  • Nordhausen, Germany, 99734
    • Novartis Investigative Site
  • Nürnberg, Germany, 90461
    • Novartis Investigative Site
  • Offenbach, Germany, 63069
    • Novartis Investigative Site
  • Oldenburg, Germany, 26122
    • Novartis Investigative Site
  • Oldenburg I. Holstein, Germany, 23758
    • Novartis Investigative Site
  • Osnabrueck, Germany, 49076
    • Novartis Investigative Site
  • Osnabrück, Germany, 49074
    • Novartis Investigative Site
  • Osnabrück, Germany, 49076
    • Novartis Investigative Site
  • Osnabrück, Germany, 49078
    • Novartis Investigative Site
  • Paderborn, Germany, 33098
    • Novartis Investigative Site
  • Papenburg, Germany, 26871
    • Novartis Investigative Site
  • Pforzheim, Germany, 75172
    • Novartis Investigative Site
  • Potsdam, Germany, 14471
    • Novartis Investigative Site
  • Prien, Germany, 83209
    • Novartis Investigative Site
  • Quakenbrueck, Germany, 49610
    • Novartis Investigative Site
  • Querfurt, Germany, 06268
    • Novartis Investigative Site
  • Ravensburg, Germany, 88212
    • Novartis Investigative Site
  • Recklinghausen, Germany, 45657
    • Novartis Investigative Site
  • Regensburg, Germany, 93059
    • Novartis Investigative Site
  • Remscheid, Germany, 42853
    • Novartis Investigative Site
  • Rostock, Germany, 18057
    • Novartis Investigative Site
  • Rüdersdorf, Germany, 15562
    • Novartis Investigative Site
  • Saarbruecken, Germany, 66113
    • Novartis Investigative Site
  • Saint Ingbert, Germany, 66386
    • Novartis Investigative Site
  • Sande, Germany, 26452
    • Novartis Investigative Site
  • Schwalmstadt-Treysa, Germany, 34613
    • Novartis Investigative Site
  • Schwerin, Germany, 19057
    • Novartis Investigative Site
  • Siegen, Germany, 57076
    • Novartis Investigative Site
  • Singen, Germany, 78224
    • Novartis Investigative Site
  • Sinsheim, Germany, 74889
    • Novartis Investigative Site
  • Solingen, Germany, 42719
    • Novartis Investigative Site
  • Stade, Germany, 21682
    • Novartis Investigative Site
  • Stadtroda, Germany, 07646
    • Novartis Investigative Site
  • Stralsund, Germany, 18439
    • Novartis Investigative Site
  • Stuttgart, Germany, 70174
    • Novartis Investigative Site
  • Stuttgart, Germany, 70178
    • Novartis Investigative Site
  • Stuttgart, Germany, 70182
    • Novartis Investigative Site
  • Stuttgart, Germany, 70176
    • Novartis Investigative Site
  • Telgte, Germany, 48291
    • Novartis Investigative Site
  • Teupitz, Germany, 15755
    • Novartis Investigative Site
  • Troisdorf, Germany, 53844
    • Novartis Investigative Site
  • Tübingen, Germany, 72076
    • Novartis Investigative Site
  • Ulm, Germany, 89081
    • Novartis Investigative Site
  • Ulm, Germany, 89073
    • Novartis Investigative Site
  • Unterhaching, Germany, 82008
    • Novartis Investigative Site
  • Wasserburg, Germany, 83512
    • Novartis Investigative Site
  • Wendlingen, Germany, 73240
    • Novartis Investigative Site
  • Wermsdorf, Germany, 04779
    • Novartis Investigative Site
  • Westerstede, Germany, 26655
    • Novartis Investigative Site
  • Westerstede/Oldenburg, Germany, 26655
    • Novartis Investigative Site
  • Wiesbaden, Germany, 65191
    • Novartis Investigative Site
  • Wiesbaden, Germany, 65183
    • Novartis Investigative Site
  • Wolfratshausen, Germany, 82515
    • Novartis Investigative Site
  • Wuppertal, Germany, 42283
    • Novartis Investigative Site
  • Wuppertal, Germany, 42103
    • Novartis Investigative Site
  • Würzburg, Germany, 97070
    • Novartis Investigative Site
  • Würzburg, Germany, 97080
    • Novartis Investigative Site
  • Zwickau, Germany, 08060
    • Novartis Investigative Site
  • Öhringen, Germany, 74613
    • Novartis Investigative Site
  • Baden-Wuerttemberg
    • Ostfildern, Baden-Wuerttemberg, Germany, 73760
      • Novartis Investigative Site
  • Bavaria
    • Munich, Bavaria, Germany, 81241
      • Novartis Investigative Site
  • Nordrhein-Westfalen
    • Koeln, Nordrhein-Westfalen, Germany, 50937
      • Novartis Investigative Site
  • Schleswig Holstein
    • Flensburg, Schleswig Holstein, Germany, 24939
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• Subjects with relapsing remitting MS.
• Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy.
• Patients who had been previously on 2nd line therapies. It was understood that these patients satisfied the above mentioned criteria listed under a. in the past.

This also included patients, who were previously treated with fingolimod (regardless of whether or not they had already been treated within the START study) but discontinued treatment due to medical reasons.

- or patients with rapidly evolving severe RRMS (e.g. > 2 relapses with disease progression in one year and > 1 Gd-enhancing lesion or with a significant increase in T2 lesions compared to a recent MRI).

Key Exclusion Criteria:

• immunocompromised patients
• active infections
• pregnant or nursing women, women of childbearing potential unless using 2 reliable forms of contraception
• presence of malignancy (other than localized basal cell carcinoma of the skin).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fingolimod; Fingolimod 0.5 mg by mouth once daily for 7 days.	Drug: FTY720; Other Names: 0.5 mg gelatin capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants With 2nd or 3rd Degree Atrioventricular (AV) Block	AV Blocks/Heart block is an abnormal heart rhythm where the heart beats too slowly; the electrical signals that tell the heart to contract are partially intermittent (Type 2:1) or slowed (1st and 2nd degree) or blocked (3rd degree) between the upper chambers (atria) and the lower chambers (ventricles). In 2nd degree AV Blocks, electrical impulses are intermittent (type 2:1) or delayed w/ each subsequent heartbeat (Mobitz type I) until a beat fails to reach the ventricles entirely. This type of block often is physiologic and observed in a highly relaxed state & during sleep. In 2nd degree AV Blocks type II, the atria electrical impulses are unable to reach the ventricles, a more serious condition. In 3rd degree AV Blocks (complete heart block), none of the electrical impulses reach either the atria or the ventricles. Patients can experience simultaneously both types of 2nd or 3rd degree AV Blocks without any symptoms.	baseline, during 6 hour monitoring post first dose observation
Number of Patients With Heart Rate Below 45 Beats Per Minute (BPM)	Number of patients with heart rate below 45 beats bpm in ECG during first dose observation	baseline during 6 hour monitoring post dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Prolonged QTc Interval (Friderica)	Number of patients with conduction abnormalities such as QT prolongation, first degree AV block during treatment initiation. The QT interval is a period between the activation and the regeneration of ventricular contraction. A prolonged QT interval can be a potential marker of cardiac arrhythmias. Two patients of the safety analysis set discontinued the study without having received treatment, but safety information was collected on these two patients.	baseline post-dose
Number of Participants With Bradyarrhythmic Electrocardiogram (ECG) Events	The number of participants with bradyarrhythmic electrocardiogram (ECG) events was assessed. Bradyarrhythmic ECG events are defined as QTc Fridericia time > 450 ms for males and > 470 ms for females.	up to day 7
Number of Patients With Cardiac Adverse Events	The number of participants with the occurrence of subsequent cardiac adverse events (AEs) and serious cardiac AEs during study was assessed. Cardiac events were defined as the following Medical Dictionary for Regulatory Activities (MedDRA) preferred terms: angina pectoris, chest discomfort, dizziness, dyspnoea, dyspnoea exertional, fatigue, palpitations, syncope, vertigo, vertigo positional and vision blurred.	7 days

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

General Publications

• Limmroth V, Ziemssen T, Lang M, Richter S, Wagner B, Haas J, Schmidt S, Gerbershagen K, Lassek C, Klotz L, Hoffmann O, Albert C, Schuh K, Baier-Ebert M, Wendt G, Schieb H, Hoyer S, Dechend R, Haverkamp W. Electrocardiographic assessments and cardiac events after fingolimod first dose - a comprehensive monitoring study. BMC Neurol. 2017 Jan 18;17(1):11. doi: 10.1186/s12883-016-0789-7.

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2012
• Primary Completion (Actual): December 12, 2016
• Study Completion (Actual): December 12, 2016

Study Registration Dates

• First Submitted: April 23, 2012
• First Submitted That Met QC Criteria: April 24, 2012
• First Posted (Estimate): April 25, 2012

Study Record Updates

• Last Update Posted (Actual): September 23, 2019
• Last Update Submitted That Met QC Criteria: August 21, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; MS; Fingolimod; Gilenya; ECG; Bradyarrythmia; conduction abnormalities; first dose observation
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Immunosuppressive Agents; Immunologic Factors; Sphingosine 1 Phosphate Receptor Modulators; Fingolimod Hydrochloride
• Other Study ID Numbers: CFTY720DDE17