Status:
TERMINATED
Fingolimod Versus Dimethyl-fumarate in Multiple Sclerosis
Lead Sponsor:
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Universita degli Studi di Genova
Conditions:
Relapsing Remitting Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This will be a 1:1 randomized open label trial. European and outside Europe centres will be involved. Aim of the project is to conduct a head-to-head comparison of effectiveness of two approved diseas...
Detailed Description
Background and significance 1\. The expansion of the treatment landscape in MS has increased the complexity of treatment decisions. Recommendations and algorithms can help to maximize the benefit of ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2019
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT03345940
Start Date
April 30 2017
End Date
October 30 2019
Last Update
October 31 2019
Active Locations (1)
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1
Fondazione IRCCS Istituto Neurologico C. Besta, Neuroimmunology Unit
Milan, Italy, 20133