Back to Search
Start Over
Study design of PANGAEA 2.0, a non-interventional study on RRMS patients to be switched to fingolimod.
- Source :
- BMC Neurology; 8/8/2016, Vol. 16, p1-11, 11p, 4 Diagrams, 1 Chart
- Publication Year :
- 2016
-
Abstract
- <bold>Background: </bold>The therapeutic options for patients with Multiple Sclerosis (MS) have steadily increased due to the approval of new substances that now supplement traditional first-line agents, demanding a paradigm shift in the assessment of disease activity and treatment response in clinical routine. Here, we report the study design of PANGAEA 2.0 (Post-Authorization Non-interventional GermAn treatment benefit study of GilEnyA in MS patients), a non-interventional study in patients with relapsing-remitting MS (RRMS) identify patients with disease activity and monitor their disease course after treatment switch to fingolimod (Gilenya®), an oral medication approved for patients with highly active RRMS.<bold>Method/design: </bold>In the first phase of the PANGAEA 2.0 study the disease activity status of patients receiving a disease-modifying therapy (DMT) is evaluated in order to identify patients at risk of disease progression. This evaluation is based on outcome parameters for both clinical disease activity and magnetic resonance imaging (MRI), and subclinical measures, describing disease activity from the physician's and the patient's perspective. In the second phase of the study, 1500 RRMS patients identified as being non-responders and switched to fingolimod (oral, 0.5 mg/daily) are followed-up for 3 years. Data on relapse activity, disability progression, MRI lesions, and brain volume loss will be assessed in accordance to 'no evidence of disease activity-4' (NEDA-4). The modified Rio score, currently validated for the evaluation of treatment response to interferons, will be used to evaluate the treatment response to fingolimod. The MS management software MSDS3D will guide physicians through the complex processes of diagnosis and treatment. A sub-study further analyzes the benefits of a standardized quantitative evaluation of routine MRI scans by a central reading facility. PANGAEA 2.0 is being conducted between June 2015 and December 2019 in 350 neurological practices and centers in Germany, including 100 centers participating in the sub-study.<bold>Discussion: </bold>PANGAEA 2.0 will not only evaluate the long-term benefit of a treatment change to fingolimod but also the applicability of new concepts of data acquisition, assessment of MS disease activity and evaluation of treatment response for the in clinical routine.<bold>Trial Registration: </bold>BfArM6532; Trial Registration Date: 20/05/2015. [ABSTRACT FROM AUTHOR]
- Subjects :
- MULTIPLE sclerosis
MULTIPLE sclerosis treatment
DISEASE relapse
FINGOLIMOD
DISEASE progression
DRUG efficacy
MEDICATION safety
PATIENTS
IMMUNOSUPPRESSIVE agents
CLINICAL trials
COMPARATIVE studies
DOCUMENTATION
DRUG monitoring
LONGITUDINAL method
MAGNETIC resonance imaging
RESEARCH methodology
MEDICAL cooperation
RESEARCH
SAFETY
EVALUATION research
TREATMENT effectiveness
Subjects
Details
- Language :
- English
- ISSN :
- 14712377
- Volume :
- 16
- Database :
- Complementary Index
- Journal :
- BMC Neurology
- Publication Type :
- Academic Journal
- Accession number :
- 117328597
- Full Text :
- https://doi.org/10.1186/s12883-016-0648-6