Studiencode: OBS13434
| Institution: | Sanofi-Aventis Deutschland GmbH | ||
| Titel der NIS: | A prospective, multicenter, observational, post-authorization safety study (PASS) to evaluate the long term safety profile of LEMTRAD® (alemtuzumab) treatment in patients with relapsing forms of multiple sclerosis (RMS) (OBS13434) | ||
| Ziel der NIS: | The overall goal of the study is to further evaluate the necessary duration and appropriate conditions of monitoring LEMTRADA treatment in relapsing multiple sclerosis (RMS) patients by determining the incidence of adverse events of special interest (AESI) to further characterize the long-term safety profile. |
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| Ort der Durchführung: | multinational | NIS angefordert: | ja |
| Patientenanzahl insgesamt: | 3000 | Anzahl Ärzte insgesamt: | 500-1000 |
| Patientenanzahl in Deutschland: | 00 - 200 | Ärzte in Deutschland: | 20 |
| Anzeige am: | 21.07.2015 | Geplanter Beginn: | 12.02.2016 | Geplantes Ende: | 28.07.2028 |
| Arzneimittelbezeichnung | INN | Zulassungs-Nr. | ATC-Code | Substanzklasse |
|---|---|---|---|---|
| Lemtrada | Alemtuzumab | EU/1/13/869/001 | L04AA34 | Selektive Immunsuppressiva |
