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
|
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 |
Abschlussbericht, NIS 305 |
pdf 2MB |