Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001280-49 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective, open-label, multi-center phase IV study to assess response to fingolimod initiation according to coping profile in adult patients with highly active relapsing remitting multiple sclerosis in France.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fingolimod | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fingolimod | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the mean change in Hospital Anxiety Depression Scale (HADS) anxiety sub-score between baseline and Month 4 in RRMS fingolimod treated patient total population, and according to coping profile (task, emotion or avoidance oriented). | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| To assess patient Clinical Global Impression (CGI) and clinician CGI at M4 in total population, and according to coping profile. | 4 months | |
| To evaluate the safety and tolerability of fingolimod 0.5 mg/day (especially initial cardiac effects, liver function and macular edema onset) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Angers | France | 49033 | France | ||
| Novartis Investigative Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 4 months |
| To explore treatment satisfaction with fingolimod in patients with RRMS either naive (rapidly evolving severe RRMS) or who transitioned from previous treatment with Disease Modifying Therapy using the TSQM 9 and according to coping profile | 4 months |
| Agen |
| 47923 |
| France |
| Novartis Investigative Site | Amiens | 80054 | France |
| Novartis Investigative Site | Auxerre | 89000 | France |
| Novartis Investigative Site | Avignon | 84000 | France |
| Novartis Investigative Site | Bayonne | 64109 | France |
| Novartis Investigative Site | Béziers | 34525 | France |
| Novartis Investigative Site | Bobigny | 93009 | France |
| Novartis Investigative Site | Brest | 29240 | France |
| Novartis Investigative Site | Calais | 62107 | France |
| Novartis Investigative Site | Castelnau-le-Lez | 34170 | France |
| Novartis Investigative Site | Chambray-lès-Tours | 37175 | France |
| Novartis Investigative Site | Cherbourg | 50100 | France |
| Novartis Investigative Site | Clermont-Ferrand | 63003 | France |
| Novartis Investigative Site | Créteil | 94010 | France |
| Novartis Investigative Site | Dijon | 21034 | France |
| Novartis Investigative Site | Épinal | 88021 | France |
| Novartis Investigative Site | Grenoble | 38042 | France |
| Novartis Investigative Site | Hagueneau | 67500 | France |
| Novartis Investigative Site | La Rochelle | 17019 | France |
| Novartis Investigative Site | La Seyne-sur-Mer | 83500 | France |
| Novartis Investigative Site | Le Kremlin-Bicêtre | 94275 | France |
| Novartis Investigative Site | Le Mans | 72037 | France |
| Novartis Investigative Site | Limoges | France |
| Novartis Investigative Site | Lyon | 69275 | France |
| Novartis Investigative Site | Marseille | 13008 | France |
| Novartis Investigative Site | Marseille | 13012 | France |
| Novartis Investigative Site | Metz | 57085 | France |
| Novartis Investigative Site | Montpellier | 34000 | France |
| Novartis Investigative Site | Montpellier | 34295 | France |
| Novartis Investigative Site | Nîmes | 32900 | France |
| Novartis Investigative Site | Orsay | 91401 | France |
| Novartis Investigative Site | Paris | 75005 | France |
| Novartis Investigative Site | Poitiers | 86021 | France |
| Novartis Investigative Site | Pontoise | F-95300 | France |
| Novartis Investigative Site | Reims | 51092 | France |
| Novartis Investigative Site | Rennes | 35033 | France |
| Novartis Investigative Site | Roanne | 42328 | France |
| Novartis Investigative Site | Saint-Aubin-sur-Scie | 76550 | France |
| Novartis Investigative Site | Saint-Jean | 31243 | France |
| Novartis Investigative Site | Sainte-Foy-lès-Lyon | 69110 | France |
| Novartis Investigative Site | Saumur | 49400 | France |
| Novartis Investigative Site | Strasbourg | 67091 | France |
| Novartis Investigative Site | Talant | 21240 | France |
| Novartis Investigative Site | Toulouse | 31059 | France |
| Novartis Investigative Site | Tourcoing | 59200 | France |
| Novartis Investigative Site | Tours | 37044 | France |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D009103 | Multiple Sclerosis |
| D001008 | Anxiety Disorders |
| D009043 | Motor Activity |
| 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 |
| D001523 | Mental Disorders |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068876 | Fingolimod Hydrochloride |
| ID | Term |
|---|---|
| D013110 | Sphingosine |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D011409 | Propylene Glycols |
| D006018 | Glycols |
| D000588 | Amines |
Not provided
Not provided