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
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						| Abschlussbericht, NIS 326 | pdf 2MB
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