Study to Assess Resource Utilization and Quality of Life of Patients With RRMS Treated With Tecfidera in Greece

RRMS Clinical Trial

— FIDELITY  

Official title:

A Real Life, Non-interventional, Multicentre Study to Assess Resource Utilization and Quality of Life of Patients With Relapsing Forms of Multiple Sclerosis Treated With Dimethyl Fumarate in Greece - the FIDELITY Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03101735
• Other study ID #: NIS-GEN-DMF-001
• Status: Completed
• Start date: September 23, 2016
• Est. completion date: April 23, 2020

Study information

• Verified date: February 2020
• Source: Genesis Pharma CNS & Specialty
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 455
• Est. completion date: April 23, 2020
• Est. primary completion date: April 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Persons aged 18-65 years.
• Patients with a confirmed diagnosis of RRMS.
• Patients for whom the decision to prescribe therapy with Tecfidera®, according to the locally approved product's summary of product characteristics (SmPC) has already been taken prior to their enrolment in the study. The assignment of a patient to this therapeutic strategy is not decided in advance, but falls within current practice, while the prescription of Tecfidera® is clearly separated from the physician's decision to include the patient in the current study.
• Patients must have signed an informed consent document.
• Patients must be able to read, understand and complete the study specific questionnaire.

Exclusion Criteria:

• Patients having other forms of MS, like Clinically Isolated Syndrome (CIS) or progressive forms.
• Patients who have initiated treatment with Tecfidera® more than 7 days before study enrolment or have received DMF at any different time prior to this period.
• Patients that meet any of the contraindications to the administration of the study drug according to the approved SmPC.
• Receipt of any investigational agent within 30 days or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with Tecfidera®.

Related Conditions & MeSH terms

• RRMS

Intervention

Drug:
• Dimethyl Fumarate (DMF)
The non-interventional design allows the observation of patients in a broad range of settings reflecting routine clinical practice. All decisions on therapeutic or diagnostic procedures, treatments, management of the disease, or resource utilisation will be at the full discretion of the treating physician without interference by a sponsor or study protocol. All treatment decisions will follow the real-life treatment behaviour.

Locations

Country	Name	City	State
Greece	University General Hospital AHEPA (B')	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Genesis Pharma CNS & Specialty

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Cost	The primary endpoint of this study is the total cost, at the end of the study, of treatment, of the utilization of healthcare services, and of personal expenses associated with RRMS in patients receiving Dimethyl Fumarate.	The primary outcome measure will be assessed at 6, 12, 18 and 24 months post recruitment. The data that will be presented is the total societal costs to the healthcare system related to the use of Tecfidera.