D

Phase 1

• Conditions: Relapsing Remitting Multiple Sclerosis; MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-000708-26-IT
• Lead Sponsor: FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-22
• Last Update Posted: 28 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

They will be included in the study patients male or female aged> 18 years, affected from relapsing remitting multiple sclerosis with high disease activity. Patients will be eligible to treatment with fingolimod according to the data sheet of the drug. In summary, they are deemed eligible for treatment with fingolimod patients belonging to one of the following groups:
1) Patients with high disease activity despite treatment with a beta-interferon. These patients may be defined as those who have not responded to a full and adequate course of therapy (normally at least one year of treatment) of beta-interferon. Patients should have had at least 1 relapse in the previous year while on therapy, and have at least 9 T2-hyperintense lesions in cranial MRI or at least 1 Gadolinium-enhancing lesion. Patient non-responders can also be defined as a patient who has, over the previous year, an unchanged or increased relapse rate or who have severe relapses.
2) Patients with severe relapsing-remitting multiple sclerosis rapidly evolving, defined as two or more disabling relapses in one year, and with 1 or more gadolinium-enhancing lesions on brain MRI or a significant increase in T2 lesion load compared to a previous RM recently performed. For all therapeutic indications the dose is 0.5 mg orally, once daily.
3) The women of childbearing age will be enrolled only if they make use of highly effective contraceptive measures. The use of contraceptive measures must be extended to male patients with partners of childbearing age.
Highly effective contraceptive measures deemed, under specific CTFG the recommendations are as follows:
_ combined (estrogen and progestogen containing) hormonal contraception
associated with inhibition of ovulation 1:
o oral
o intravaginal
o transdermal
_ progestogen-only hormonal contraception associated with inhibition of ovulation 1:
o oral
o injectable
o implantable 2
_ intrauterine device (IUD)
_ intrauterine hormone-releasing system ( IUS)
_ bilateral tubal occlusion
_ vasectomised partner
_ sexual abstinence

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Patients with HIV (a specific serologic testing for HIV should be conducted prior to initiating treatment with fingolimod).
Patients who are at increased risk for opportunistic infections, including immunocompromised patients (including those currently receiving immunosuppressive therapies or those immunocompromised by prior therapies).
• Patients infected with HBV, HCV and HAV (before starting treatment with Gilenya should be performed the following serological tests: HBsAg, HBcAb, anti HCV antibodies, anti HAV IgM and IgG).
• Patients with latent or active tuberculosis (before starting treatment with Gilenya should be performed dosing Quantiferon test)
• Malignant tumors diagnosed in the active phase.
• Severe hepatic impairment (Child-Pugh Class C).
• Hypersensitivity to the active substance or to any of the excipients.
• Patients treated with live vaccines within 30 days prior to screening
• Women of childbearing potential and not complianti highly effective contraceptive measures defined in accordance with the recommendations of the Clinical Trial Facilitation Group (http://www.hma.eu/fileadmin/dateien/Human_Medicines/01About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf)
• Male patients with partners of childbearing age who do not belong to highly effective contraceptive measures defined in accordance with the recommendations of Clinical Trial Facilitation Group
• Women who are pregnant or breast-feeding (in all women of childbearing age before you start treatment with Gilenya will be made the dosage of beta-HCG in serum, and also will be made a urinary pregnancy test every month during treatment as required by the recommendations of the Clinical Trial Facilitation Group)
• Patients with moderate to severe heart failure (III / IV class according to the New York Heart Association)
• Documented relapse or steroid therapy ev a month before the start of therapy
• Patients who have discontinued treatment with fingolimod following an inadequate response

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified