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To evaluate the safety and efficacy of fingolimod 0.5mg vs. placebo in MS patients in China
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| double blinded Fingolimod 6 mos + open label fingolimod 6 mos | Experimental | Randomized to 6 month (180 days) 0.5 mg fingolimod + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily |
|
| Placebo 6 mos + open label fingolimod 6 mos | Placebo Comparator | Randomized to 6 month (180 days) matching placebo + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fingolimod | Drug | Randomized to 6 month (180 days) 0.5 mg fingolimod + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| number of new/newly enlarged T2 MRI lesions over 6 months | Cumulative number of new/newly enlarged T2 lesions over 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| annualized relapse rate (ARR) | The annualized relapse rate (ARR) is identified as the average number of confirmed relapses per year (the total number of confirmed relapses divided by the total days in the study multiplied by 365.25). The number of relapses will include all the confirmed relapses during the study. The time spent in the study will correspond to the observation period for all the relapses from first dose on the study drug to end of study. |
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Inclusion Criteria:
-Patients must have relapsing remitting multiple sclerosis
Exclusion Criteria:
Patients with:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
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| 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 |
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| ID | Term |
|---|---|
| D000068876 | Fingolimod Hydrochloride |
| ID | Term |
|---|---|
| D013110 | Sphingosine |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Placebo (6mos) + open label fingolimod (6 mos) | Drug | Randomized to 6 month (180 days) matching placebo + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily |
|
| 6 months |
| number of Gd-enhancing T1 lesions | 6 months |
| Safety and tolerability of fingolimod 0.5 mg compared to placebo | Based on frequency of adverse events (the number and percentage of patients having any AE by primary system organ class and preferred term) and on the incidence of clinically notable abnormalities | 12 months |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011409 |
| Propylene Glycols |
| D006018 | Glycols |
| D000588 | Amines |