Studiencode: PS0035
| Institution: | Parexel International GmbH | Auftraggeber: | UCB Biopharma SRL |
| Titel der NIS: | Observational study of treatment history, quality of life, treatment satisfaction, and disease symptom severity in adult patients with moderate to severe plaque psoriasis treated with bimekizumab in routine clinical practice | ||
| Ziel der NIS: | The primary objective of the study is to characterize the treatment history for patients initiating bimekizumab and to describe the proportion of patients reporting that their moderate to severe psoriasis (PSO) has no effect on their quality of life, as measured by the Dermatology Life Quality Index total score of 0 or 1 (DLQI 0/1) after 26 weeks of treatment with bimekizumab, stratified by treatment history. |
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| Ort der Durchführung: | multinational | NIS angefordert: | nein |
| Patientenanzahl insgesamt: | 1500 | Anzahl Ärzte insgesamt: | 140 |
| Patientenanzahl in Deutschland: | 750 | Ärzte in Deutschland: | 70 |
| Anzeige am: | 13.10.2021 | Geplanter Beginn: | 30.11.2021 | Geplantes Ende: | 15.12.2024 |
| Arzneimittelbezeichnung | INN | Zulassungs-Nr. | ATC-Code | Substanzklasse |
|---|---|---|---|---|
| Bimekizumab | Bimekizumab | EU/1/21/1575/001-8 | L04AC21 | Immunosuppressiva |
| Art des Dokuments | |
|---|---|
| Beobachtungsplan, NIS 630 | pdf 1MB |
