Nicht-interventionelle Studie (Anwendungsbeobachtung) NIS-Nr.: 377
Studiencode: CACZ885DDE06
Allgemeine Angaben
Institution: |
Novartis Pharma GmbH |
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Titel der NIS: |
RELIANCE – Real life non-interventional study on longterm outcome of Ilaris® (canakinumab) treated CAPS patients |
Ziel der NIS: |
Research question and objectives
The objective of this non-interventional study is to monitor and further explore long-term outcome of CAPS patients treated with Ilaris® in terms of disease course as well as quality of life and health economic aspects - under conditions of standard clinical practice in Germany. The usage of Ilaris® and the population receiving Ilaris® for CAPS under conditions of standard clinical practice shall be described.
Endpoints:
This prospective, non-interventional, multi-center study will evaluate the following endpoints:
Describe the usage and patterns of dosing of Ilaris® in routine clinical practice.
Description of the population receiving Ilaris® for CAPS under conditions of standard clinical practice regarding details on CAPS diagnosis and laboratory parameters.
Physician global assessment (PGA) of autoinflammatory disease activity [5-point scale (absent, minimal, mild, moderate, or severe)] comprising urticarial skin rash, arthralgia,
Novartis Vertraulich
Beobachtungsplan Nicht-interventionelle Studie ACZ885 / Ilaris / CACZ885DDE06
Seite 6 von 37
NIS 01 001
myalgia, headache, migraine, conjunctivitis, fatigue or malaise, abdominal pain, amongst other symptoms that may appear.
The long-term impact of Ilaris® on disease progression / improvement consisting of but not limited to AA-Amyloidosis as evidenced by renal function, neurologic and ophthalmologic symptoms and sensorineural deafness, skin disease, serologic markers of inflammation (CRP, ESR, serum amyloid A-protein (SAA), IL-6) in CAPS patients treated with Ilaris.
Explore growth and development patterns (normal / retarded) of children aged ≥2 to ≤17 years of age exposed to Ilaris®.
Patient-reported outcome as captured by disease-specific questionnaire (used as in clinical routine; VAS / AIDAI) capturing amongst others appearance of fever/chills, skin rash, joint/muscle, pain, eye discomfort/redness, fatigue, headache.
Ressource utilization
Routine safety monitoring. Adverse events will be reported according to pharmacovigilance requirements.
Patients who previously had been enrolled into a Novartis clinical study with Canakinumab (Ilaris) will be asked if they volunteer for compiled data analysis from previous data collection.
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Ort der Durchführung: |
nur Deutschland |
NIS angefordert: |
nein |
Patientenanzahl insgesamt: |
300 |
Anzahl Ärzte insgesamt: |
15 |
Patientenanzahl in Deutschland: |
300 |
Ärzte in Deutschland: |
15 |
Weitere Angaben und Unterlagen
Anzeige am: |
27.10.2016 |
Geplanter Beginn: |
27.09.2017 |
Geplantes Ende: |
31.12.2022 |
Angezeigtes Ende der NIS am: nicht vorhanden |
Angaben zu den beobachteten Arzneimitteln, soweit angezeigt
Arzneimittelbezeichnung |
INN |
Zulassungs-Nr. |
ATC-Code |
Substanzklasse |
Ilaris |
canakinumab |
EU/1/09/564/001 – 002 |
L04AC08 |
L04AC08 |
Verfügbare Dokumente
Art des Dokuments |
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Beobachtungsplan, NIS 377 |
pdf 300KB |