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

NCT ID: NCT03101735

Last Updated: 2021-07-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 455 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-23
• Study Completion Date: 2020-04-23

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.

Conditions

RRMS

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Tecfidera

Eligibility Criteria

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®.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genesis Pharma CNS & Specialty

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University General Hospital AHEPA (B')

Thessaloniki, , Greece

Countries

Greece

Other Identifiers

NIS-GEN-DMF-001

Identifier Type: -

Identifier Source: org_study_id