Studiencode: ML39348
| Institution: | Roche Pharma AG, Grenzach-Wyhlen | Auftraggeber: | Roche Pharma AG, Grenzach-Wyhlen |
| Titel der NIS: | EVALUATION OF SPECIFIC UNMET NEEDS IN CURRENT CLINICAL PRACTICE OF MULTIPLE SCLEROSIS: CHARACTERIZATION OF DIFFERENT PROFILES OF RELAPSING MULTIPLE SCLEROSIS PATIENTS DEFINED BY DISEASE ACTIVITY AND PATIENT-REPORTED OUTCOMES (PROFILE RMS) | ||
| Ziel der NIS: | In the PROFILE study, different profiles of multiple sclerosis (MS) patients should be generated and prospectively followed up to characterize the unmet needs in current MS patient care. To characterize the unmet needs, different methods are implemented in the prospective assessment of the selected MS patients. In addition to the characterization of different MS profiles, the frequency of these respective profiles will be calculated by a prospective continuous recruitment. |
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| Ort der Durchführung: | nur Deutschland | NIS angefordert: | nein |
| Patientenanzahl insgesamt: | 1107 | Anzahl Ärzte insgesamt: | 67 |
| Patientenanzahl in Deutschland: | 1107 | Ärzte in Deutschland: | 67 |
| Anzeige am: | 09.08.2017 | Geplanter Beginn: | 01.07.2018 | Geplantes Ende: | 01.01.2023 |
| Angezeigtes Ende der NIS am: nicht vorhanden | |||||
| Arzneimittelbezeichnung | INN | Zulassungs-Nr. | ATC-Code | Substanzklasse |
|---|---|---|---|---|
| Tysabri | Natalizumab | EU/1/06/346/001 | L04AA23 | Selective immunosuppressive agents |
| Zinbryta | Daclizumab | EU/1/16/1107/001-004 | L04AC01 | immunosuppressants, interleukin inhibitors |
| Lemtrada | Alemtuzumab | EU/1/13/869/001 | L04AA34 | Selective immunosuppressants |
| Ocrevus | Ocrelizumab | EU/1/17/1231/001-002 | L04AA36 | Selective immunosuppressants |
