Nicht-interventionelle Studie (Anwendungsbeobachtung) NIS-Nr.: 71
Studiencode: CACZ885D2401
Allgemeine Angaben
| Institution: |
Novartis Pharma GmbH |
Auftraggeber: |
Novartis Pharma GmbH |
| Titel der NIS: |
β-Confident
Clinical Outcomes and Safety: A Registry Study of Ilaris® (canakinumab) Patients
An open-label, long-term, prospective, observational study to monitor the safety and effectiveness of Ilaris in CAPS
patients |
| Ziel der NIS: |
Primary objective
The primary objective of the β-CONFIDENT Registry is to monitor and further explore the
overall safety of Ilaris® in patients with CAPS focusing on serious infections, malignancies,
hypersensitivity reactions, vertigo and other selected events.
3.2 Secondary objectives
The secondary objectives of the β-CONFIDENT Registry are to:
• Describe the long-term impact of Ilaris® on disease progression (including systemic AA
amyloidosis as evidenced by renal function, neurologic and ophthalmologic symptoms,
and sensorineural deafness);
• Explore growth and development patterns in children aged ≥2 or ≥4 (depending on local
label) to ≤17 years of age exposed to Ilaris®;
• Identify previously unrecognized serious adverse drug reactions in the treated population;
• Describe the usage and patterns of dosing of Ilaris® in routine clinical practice.
|
| Ort der Durchführung: |
multinational |
NIS angefordert: |
nein |
| Patientenanzahl insgesamt: |
270 |
Anzahl Ärzte insgesamt: |
80 |
| Patientenanzahl in Deutschland: |
80 |
Ärzte in Deutschland: |
10 |
Weitere Angaben und Unterlagen
| Anzeige am: |
18.11.2009 |
Geplanter Beginn: |
16.11.2009 |
Geplantes Ende: |
17.02.2016 |
| Angezeigtes Ende der NIS am: 17.02.2016 |
Angaben zu den beobachteten Arzneimitteln, soweit angezeigt
| Arzneimittelbezeichnung |
INN |
Zulassungs-Nr. |
ATC-Code |
Substanzklasse |
| Ilaris |
Canakinumab |
|
L04AC08 |
L04AC08 |
Verfügbare Dokumente
| Art des Dokuments |
|
| Beobachtungsplan, NIS 71 |
pdf
490KB |
| Abschlussbericht, NIS 71 |
pdf
667KB |
