Nicht-interventionelle Studie (Anwendungsbeobachtung) NIS-Nr.: 305
		Studiencode: C1231001 (Hospira Protocol ZOB INF 1402)
Allgemeine Angaben
		
			
			
				| Institution: | UBC Late Stage (UK) Ltd. | Auftraggeber: | Hospira UK Ltd. | 
			
				| Titel der NIS: | Post-Marketing Observational Cohort Study of Patients with Inflammatory Bowel Disease (IBD) Treated with CT-P13 in Usual Clinical Practice (CONNECT-IBD) | 
			
				| Ziel der NIS: | Primary study objectives:- To characterise the population and drug utilisation patterns of patients treated with CT-P13 for Crohn’s Disease (CD) or Ulcerative Colitis (UC) in the context of standard of care Remicade
 - To explore the long-term safety profile of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade
 Secondary study objective:
 - To assess the effectiveness of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade
 Exploratory objectives:
 - To evaluate patient-reported outcomes (PRO) including quality of life (QoL), work productivity and healthcare resource use (HRU) in patients treated with CT-P13 for CD or UC
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				| Ort der Durchführung: | multinational | NIS angefordert: | nein | 
			
				| Patientenanzahl insgesamt: | 2565 | Anzahl Ärzte insgesamt: | 153 | 
			
				| Patientenanzahl in Deutschland: | 624 | Ärzte in Deutschland: | 25 | 
			
		
		Weitere Angaben und Unterlagen
		
			
				
					| Anzeige am: | 13.05.2015 | Geplanter Beginn: | 22.04.2015 | Geplantes Ende: | 31.10.2018 | 
				
					| Angezeigtes Ende der NIS am: 31.10.2018 | 
			
		
		Angaben zu den beobachteten Arzneimitteln, soweit angezeigt
		
			
				
					| Arzneimittelbezeichnung | INN | Zulassungs-Nr. | ATC-Code | Substanzklasse | 
			
			
				
					| Inflectra | infliximab | EU/1/13/854/001 1 vial, EU/1/13/854/002 2 vials, EU/1/13/854/003 3 vials, EU/1/13/854/004 4 vials, EU/1/13/854/005 5 vials | L04AB02 | Tumor necrosis factor alpha (TNFα) inhibitors / antibodies | 
				
					| Remicade | infliximab | EU/1/99/116/001, EU/1/99/116/002, EU/1/99/116/003, EU/1/99/116/004, EU/1/99/116/005 | L04AB02 | Tumor necrosis factor alpha (TNFα) inhibitors / antibodies | 
			
		
		Verfügbare Dokumente
		
			
				
					
						| Art des Dokuments |  | 
				
				
					
						| Beobachtungsplan, NIS 305 | pdf 4MB
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						| Abschlussbericht, NIS 305 | pdf 2MB
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