Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT03101735
Brief Summary:
This is a non interventional, multicenter clinical trial, in adult patients receiving Tecfidera per approved SmPC and routine clinical practice. The primary objective of this study is to evaluate the total societal costs to the healthcare system related to the use of Tecfidera in RRMS patients. The study will capture data in a simple matter that can be easily interpreted providing an advantage in a country where efforts in the market access arena are in their infancy. For the aforementioned reasons, the proposed study may prove quite valuable in supporting DMF as a cost-effective therapy, valuable not only for patients but for the public health care system as well, providing all the necessary information for the evaluation that need to be examined regarding the positive reimbursement list and future decisions.
Detailed Description:
The study will take place in Greece. Investigators will participate from a broad geographical distribution in order to ensure a proper representation from all areas of Greece. Investigator's decision to prescribe DMF (Tecfidera®) (according to the indication for treatment as defined in the summary of product characteristics, SmPC and the current clinical practice), should precede entry into the study.
Study:
NCT03101735
Study Brief:
Protocol Section:
NCT03101735