Fingolimod Versus Dimethyl-fumarate in Multiple Sclerosis (PRAG-MS)
Relapsing Remitting Multiple Sclerosis
About this trial
This is an interventional treatment trial for Relapsing Remitting Multiple Sclerosis focused on measuring Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria:
- Adult patients with RRMS eligible to be treated with both FTY and DMF. Patients eligible for enrolment are patients for whom both drugs can be prescribed, upon clinical judgement and local label indication.
- Patients must be able to sign and date a written informed consent prior to entering the study. Where the subject is unable to write, consent may be given and recorded through appropriate alternative means in the presence of at least one impartial witness. In that case, the witness shall sign and date the informed consent document.
- Women of child-bearing potential must have a negative serum pregnancy test before enrollment and must practice an effective method of birth control, in line with normal clinical practice recommendations.
Exclusion Criteria:
- any FTY/DMF contraindication, as for authorized indications or clinical judgment;
- present immunodeficiency syndrome (primary or secondary immune deficiency);
- abnormal lymphocyte count;
- severe chronic active infections or acute infections not resolved at the time of the enrolment;
- evidence of active tuberculosis (TB);
- history of either untreated or inadequately treated latent TB infection;
- progressive Multifocal Leukoencephalopathy, even if only suspected;
- active malignancies;
- severe liver impairment (Child-Pugh class C);
- macular edema;
- sieronegative for antibodies IgG anti-VZV;
- hypersensitivity to the active substances or to any of the excipients;
- cardiac contraindications to FTY (patients who in the last 6 months experienced myocardial infarction, unstable angina, stroke, TIA, decompensated heart failure (HF) requiring hospitalization or Class III/IV HF; history or presence of Mobitz Type II second-degree or third-degree atrioventricular (AV) block or sick sinus syndrome, unless patient has a functioning pacemaker);
- pregnancy or breastfeeding;
- concomitant treatment with any other approved or investigational DMTs or other prohibited treatments.
Sites / Locations
- Fondazione IRCCS Istituto Neurologico C. Besta, Neuroimmunology Unit
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Fingolimod 0.5 mg/day
Dimethyl Fumarate 240 mg twice daily
The study drugs, FTY and DMT, are approved and available on the market and safety and tolerability profile of both the drugs is well known. In our study, patients will be treated according to the clinical practice. Dose: FTY 0.5 mg/day or DMF 240 mg twice daily
The study drugs, FTY and DMT, are approved and available on the market and safety and tolerability profile of both the drugs is well known. In our study, patients will be treated according to the clinical practice. Dose: FTY 0.5 mg/day or DMF 240 mg twice daily