Nicht-interventionelle Studie (Anwendungsbeobachtung) NIS-Nr.: 326
Studiencode: ZOBINF1505/C1231002
Allgemeine Angaben
Institution: |
Covance Clinical and Periapproval Services Ltd |
Auftraggeber: |
Hospira Inc. |
Titel der NIS: |
PERSIST: Prospective ObsErvational CohoRt Study to Assess Persistence of CT-P13™ (Infliximab) in patients with Rheumatoid Diseases who are either Naive to biologics or Switched from sTable Remicade® (infliximab) |
Ziel der NIS: |
The study has been designed to evaluate real-life drug persistence, to characterize the patient populations and drug utilization patterns associated with the use of Inflectra™, as well as its safety and effectiveness. Data generated from this study could be used to better define significant prognostic characteristics and guide short-term management and maintenance treatment decisions and to identify unmet medical needs, monitor the safety and impact of novel biosimilar medication, and direct future research.
|
Ort der Durchführung: |
multinational |
NIS angefordert: |
nein |
Patientenanzahl insgesamt: |
351 |
Anzahl Ärzte insgesamt: |
38 |
Patientenanzahl in Deutschland: |
158 |
Ärzte in Deutschland: |
10 |
Weitere Angaben und Unterlagen
Anzeige am: |
16.10.2015 |
Geplanter Beginn: |
01.02.2016 |
Geplantes Ende: |
27.07.2018 |
Angezeigtes Ende der NIS am: 31.12.2018 |
Angaben zu den beobachteten Arzneimitteln, soweit angezeigt
Arzneimittelbezeichnung |
INN |
Zulassungs-Nr. |
ATC-Code |
Substanzklasse |
CT-P13 100 mg powder for concentrate for solution for infusion |
Infliximab |
EU/1/13/854/001-005 |
L04AB02 |
Infliximab |
Remicade 100 mg powder for concentrate for solution for infusion |
Infliximab |
EU/1/99/116/001-005 |
L04AB02 |
Infliximab |
Verfügbare Dokumente
Art des Dokuments |
|
Beobachtungsplan, NIS 326 |
pdf 3MB |
Abschlussbericht, NIS 326 |
pdf 2MB |