Fingolimod Versus Dimethyl-fumarate in Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03345940
• Date of registration: 16/05/2017
• Prospective Registration: No
• Primary sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
• Public title: Fingolimod Versus Dimethyl-fumarate in Multiple Sclerosis PRAG-MS
• Scientific title: A Multicentric Randomized PRAGmatic Trial to Compare the Effectiveness of Fingolimod Versus Dimethyl-Fumarate on Patient Overall Disease Experience in Relapsing Remitting Multiple Sclerosis: Novel Data to Inform Decision-makers
• Date of first enrolment: April 30, 2017
• Target sample size: 55
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03345940
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Italy

Contacts

• Name: Renato Mantegazza, MD
• Affiliation: Fondazione IRCCS Istituto Neurologico Carlo Besta

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Relapsing Remitting Multiple Sclerosis

Intervention(s)

Drug: Fingolimod

Drug: Dimethyl Fumarate

Primary Outcome(s)

effectiveness of fingolimod 0.5 mg once daily versus dimethyl-fumarate 240 mg twice daily [Time Frame: 24 Months]

Secondary Outcome(s)

Prevention of Cognitive decline [Time Frame: over 12 and 24 months]

Patient-NEDA [Time Frame: over 24 months]

Prevention of sustained disability progression (EDSS worsening) [Time Frame: over 24 months]

Brain volume loss [Time Frame: at 12 and 24 months]

Convenience perception [Time Frame: over 12 and 24 months]

Fatigue [Time Frame: over 12 and 24 months]

Preservation of Quality of life [Time Frame: over 12 and 24 months]

Evaluation of quality of decision making [Time Frame: over 12 and 24 months]

Number of Gd+ MRI lesions [Time Frame: at 12 and 24 months]

Psychiatric symptoms [Time Frame: over 12 and 24 months]

Annual relapse rate [Time Frame: over 12 and 24 months]

Evaluation of social cognition [Time Frame: over 12 and 24 months]

Prevention of Objective sustained disability progression [Time Frame: over 12 and 24 months]

Secondary ID(s)

2017-000559-26

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Patient-Centered Outcomes Research Institute

Universita degli Studi di Genova