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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022066-28 | EudraCT Number |
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The purpose of this study is to investigate which changes in immunological biomarkers under treatment with fingolimod in patients with relapsing-remitting multiple sclerosis can be detected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fingolimod | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fingolimod | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of Cluster of Differentiation (CD)4+ naive T cells (C-C Chemokine Receptor Type 7+(CCR7+CD45RA+) | 6 Months | |
| Change from baseline of CD8+ naïve T cells (CCR7+CD45RA+) | 6 months | |
| Change from baseline of CD4+ central memory T cells (CCR7+CD45RA-) | 6 months | |
| Change from baseline of CD8+ central memory T cells (CCR7+CD45RA-) | 6 months | |
| Change from baseline of CD8+ effector memory T-cells (CCR7-CD45RA-) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of B-lymphocytes | 6 months | |
| Change from baseline of monocytes | 6 months | |
| Change from baseline of Natural Killer cells |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Ostfildern | Baden-Wurttemberg | 73760 | Germany | ||
| Novartis Investigative Site |
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| 6 months |
| Altenholz-Stift |
| Germany |
| 24161 |
| Germany |
| Novartis Investigative Site | Andernach | Germany | 56626 | Germany |
| Novartis Investigative Site | Celle | Germany | 29223 | Germany |
| Novartis Investigative Site | Dortmund | Germany | 44135 | Germany |
| Novartis Investigative Site | Göttingen | Germany | 37073 | Germany |
| Novartis Investigative Site | Kastellaun | Germany | 56288 | Germany |
| Novartis Investigative Site | Kiel | Germany | 24105 | Germany |
| Novartis Investigative Site | Krefeld | Germany | 47800 | Germany |
| Novartis Investigative Site | Leipzig | Germany | 04299 | Germany |
| Novartis Investigative Site | Leverkusen | Germany | 51375 | Germany |
| Novartis Investigative Site | Mönchengladbach | Germany | 41239 | Germany |
| Novartis Investigative Site | Aalen | 73430 | Germany |
| Novartis Investigative Site | Abensberg | 93326 | Germany |
| Novartis Investigative Site | Alzenau in Unterfranken | 63755 | Germany |
| Novartis Investigative Site | Aschaffenburg | 63739 | Germany |
| Novartis Investigative Site | Bad Mergentheim | 97980 | Germany |
| Novartis Investigative Site | Bamberg | 96052 | Germany |
| Novartis Investigative Site | Berg | 82335 | Germany |
| Novartis Investigative Site | Berlin | 10437 | Germany |
| Novartis Investigative Site | Berlin | 10713 | Germany |
| Novartis Investigative Site | Berlin | 12165 | Germany |
| Novartis Investigative Site | Berlin | 13347 | Germany |
| Novartis Investigative Site | Bielefeld | 33611 | Germany |
| Novartis Investigative Site | Bochum | 44787 | Germany |
| Novartis Investigative Site | Bochum | 44789 | Germany |
| Novartis Investigative Site | Bochum | 44791 | Germany |
| Novartis Investigative Site | Böblingen | 71032 | Germany |
| Novartis Investigative Site | Bremen | 28755 | Germany |
| Novartis Investigative Site | Dresden | 01307 | Germany |
| Novartis Investigative Site | Düsseldorf | 40225 | Germany |
| Novartis Investigative Site | Erbach im Odenwald | 64711 | Germany |
| Novartis Investigative Site | Erlangen | 91054 | Germany |
| Novartis Investigative Site | Frankfurt | 60313 | Germany |
| Novartis Investigative Site | Fulda | 36043 | Germany |
| Novartis Investigative Site | Grevenbroich | 41515 | Germany |
| Novartis Investigative Site | Hamburg | 20249 | Germany |
| Novartis Investigative Site | Hamburg | 22083 | Germany |
| Novartis Investigative Site | Hennigsdorf | 16761 | Germany |
| Novartis Investigative Site | Jena | 07740 | Germany |
| Novartis Investigative Site | Klingenmünster | 76889 | Germany |
| Novartis Investigative Site | Lappersdorf | 93138 | Germany |
| Novartis Investigative Site | Leipzig | 04157 | Germany |
| Novartis Investigative Site | Leverkusen | 51375 | Germany |
| Novartis Investigative Site | Merzig | 66663 | Germany |
| Novartis Investigative Site | München | 81829 | Germany |
| Novartis Investigative Site | Neuburg am Inn | 86633 | Germany |
| Novartis Investigative Site | Osnabrück | 49076 | Germany |
| Novartis Investigative Site | Regensburg | 93053 | Germany |
| Novartis Investigative Site | Schwendi | 88477 | Germany |
| Novartis Investigative Site | Siegen | 57076 | Germany |
| Novartis Investigative Site | Singen | 78224 | Germany |
| Novartis Investigative Site | Stade | 21682 | Germany |
| Novartis Investigative Site | Stadtroda | 07646 | Germany |
| Novartis Investigative Site | Stuttgart | 70178 | Germany |
| Novartis Investigative Site | Troisdorf | 53844 | Germany |
| Novartis Investigative Site | Tübingen | 72076 | Germany |
| Novartis Investigative Site | Ulm | 89073 | Germany |
| Novartis Investigative Site | Unterhaching | 82008 | Germany |
| Novartis Investigative Site | Wermsdorf | 04779 | Germany |
| Novartis Investigative Site | Wolfenbüttel | 38300 | Germany |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068876 | Fingolimod Hydrochloride |
| ID | Term |
|---|---|
| D013110 | Sphingosine |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D011409 | Propylene Glycols |
| D006018 | Glycols |
| D000588 | Amines |
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