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The PANGAEA study design - a prospective, multicenter, non-interventional, long-term study on fingolimod for the treatment of multiple sclerosis in daily practice.
- Source :
-
BMC neurology [BMC Neurol] 2015 Jun 18; Vol. 15, pp. 93. Date of Electronic Publication: 2015 Jun 18. - Publication Year :
- 2015
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Abstract
- Background: Fingolimod (Gilenya) is an oral medication for patients with highly active relapsing-remitting Multiple Sclerosis (RRMS). Clinical trials and post-marketing experience on more than 114,000 patients have established a detailed safety profile. Total patient exposure now exceeds 195,000 patient-years as stated in the last financial report (Dec 2014) of the Novartis Pharma AG, Basel, Switzerland. However, less is known about the safety of long-term fingolimod use in daily practice. Here, we describe the study design of PANGAEA (Post-Authorization Non-interventional German sAfety of GilEnyA in RRMS patients), a prospective, multicenter, non-interventional, long-term study to collect safety, efficacy, and pharmacoeconomic data on RRMS patients treated with fingolimod (0.5 mg/daily) under real-world conditions in Germany.<br />Methods: PANGAEA is striving to assess a real-world safety and efficacy profile of fingolimod, based on data from 4,000 RRMS patients, obtained during a 60-month observational phase. A pharmacoeconomic sub-study of 800 RRMS patients further collects patient-reported outcome measures of disability, quality of life, compliance, treatment satisfaction, and usage of resources during a 24-month observational phase. Descriptive statistical analyses of the safety set as well as of stratified subgroups such as patients with concomitant diabetes mellitus and pretreated patients (e.g., natalizumab) will be conducted.<br />Discussion: PANGAEA seeks to confirm the current safety profile of fingolimod obtained in phase I-III clinical trials. The study design presented here will additionally provide guidance on the therapeutic use of fingolimod in clinical practice and possibly assists physicians in making evidence-based decisions.
- Subjects :
- Drug Industry
Female
Fingolimod Hydrochloride economics
Germany
Humans
Immunosuppressive Agents economics
Male
Patient Safety
Product Surveillance, Postmarketing
Propylene Glycols therapeutic use
Prospective Studies
Quality of Life
Fingolimod Hydrochloride therapeutic use
Immunosuppressive Agents therapeutic use
Multiple Sclerosis, Relapsing-Remitting drug therapy
Research Design
Subjects
Details
- Language :
- English
- ISSN :
- 1471-2377
- Volume :
- 15
- Database :
- MEDLINE
- Journal :
- BMC neurology
- Publication Type :
- Academic Journal
- Accession number :
- 26084334
- Full Text :
- https://doi.org/10.1186/s12883-015-0342-0