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

NCT03101735 | Completed

• 1 other identifier: NIS-GEN-DMF-001
• Study Type: observational
• Target: 455
• Locations: 1 country
• Sites: 1

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.

Conditions

RRMS

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

Dimethyl Fumarate (DMF) DRUG

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.

Also known as: Tecfidera

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

400 previously DMF-naïve adult patients who have been diagnosed with RRMS and will initiate treatment with Dimethyl Fumarate up to 1 week before study enrolment will be included

You may qualify if:

• 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.

You may not qualify if:

• 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®.

Sponsors & Collaborators

• Genesis Pharma CNS & Specialty: lead

Study Sites (1)

University General Hospital AHEPA (B')

Thessaloniki, 54636, Greece

Location

Related Publications (1)

• Kourlaba G, Koutsis G, Fakas N, Tsimourtou V, Karachalios G, Bakirtzis C, Grigoriadis N. The economic impact, healthcare resource utilization, and clinical outcome over 24 months in patients with relapsing-remitting multiple sclerosis treated with dimethyl fumarate in Greece- The Fidelity Study. Expert Rev Pharmacoecon Outcomes Res. 2025 Dec 18:1-11. doi: 10.1080/14737167.2025.2603955. Online ahead of print.

  PMID: 41390331 DERIVED

MeSH Terms

Interventions

Dimethyl Fumarate

Intervention Hierarchy (Ancestors)

Fumarates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: April 5, 2017
• Study Start: September 23, 2016
• Primary Completion: April 23, 2020
• Study Completion: April 23, 2020
• Last Updated: July 28, 2021

Record last verified: 2020-02

Locations

GR (1)