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NCT Number: NCT03101735

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

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University General Hospital AHEPA (B')

Thessaloniki, 54636, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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®.

Treatment and study plan

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.

Other names: Tecfidera

Primary outcomes

  1. Total Cost

    Time frame: 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.

    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.

Sponsors and collaborators

Lead sponsor

Genesis Pharma CNS & Specialty

Industry

Registry information

Official study 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

Acronym: FIDELITY

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 5, 2017
Registry last updated
Jul 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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