approximately 600 patients with relapsing-remitting MS for whom no suitable therapy exists i.e. where existing therapies have failed. MedDRA version: 14.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: fingolimod
Product Code: FTY720D
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: other nervous system drugs
CAS Number: 162359-56-0
Current Sponsor code: FINGOLIMOD
Concentration
Sponsors
NOVARTIS FARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients eligible for inclusion in this program have to fulfill all of the following criteria: 1. Written informed consent must be obtained before any assessment is performed 2. Male or female patients aged at least 18 years old 3. Patients with relapsing-remitting MS 4. Patients for whom no suitable treatment alternative exists i.e where alternative therapy has failed. 5. An Expanded Disability Status Scale (EDSS) score of 0-6.5 inclusive 6. Patients previously treated with natalizumab may be considered for inclusion only after a wash-out period of at least 3 months following discontinuation of natalizumab Are the trial subjects under 18? Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients fulfilling any of the following criteria are not eligible for inclusion in this study: 1. History of chronic disease of the immune system other than MS or a known immunodeficiency syndrome 2. History or presence of malignancy (except for successfully treated basal or squamous cell carcinoma of skin) 3. Diabetic patients with moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy or uncontrolled diabetic patients with HbA1c>8% 4. Diagnosis of macular edema (patients with a history of macular edema will be allowed to enter the program provided that they do not have macular edema at the first visit). 5. Active systemic bacterial, viral or fungal infections, or diagnosis of AIDS, Hepatitis B, Hepatitis C infection defined as a positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests, respectively 6. Patients who have no history of chickenpox and test negative for varicella-zoster virus IgG antibodies at the first visit (such patients should be considered for VZV vaccination and may be included = 1 month after vaccination) 7. Patients who have received any live or live attenuated vaccines (including for varicella-zoster virus or measles) within 1 month prior to the first visit 8. Patients who have received total lymphoid irradiation or bone marrow transplantation 9. Patients who have been treated with: • corticosteroids or adrenocorticotropic hormones (ACTH) within 1 month prior to the first visit • immunosuppressive medications such as azathioprine or methotrexate within 6 months prior to the first visit • immunoglobulins and/or monoclonal antibodies (including natalizumab) within at least 3 months prior to inclusion • cladribine, cyclophosphamide or mitoxantrone at any time 10. Any of the following cardiovascular conditions: • cardiac failure at time of the first visit (Class III, according to NYHA Classification) or any severe cardiac disease as determined by the physician • resting heart 5 mIU/mL) 13. Any of the following hepatic conditions: • known history of alcohol abuse, chronic liver or biliary disease, severe hepatic impairment (Child-Pugh class C) • total bilirubin greater than the upper limit of the normal range unless in context of Gilbert’s syndrome • conjugated bilirubin greater than the upper limit of the normal range • alkaline phosphatase (AP) greater than 1.5 times the upper limit of the normal range • AST (SGOT), ALT (SGPT) greater than 2 times the upper limit of the normal range gamma-glutamyl-transferase (GGT) greater than 3 times the upper limit of the normal range
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objectives of the study are: - provide early access to fingolimod to patients who have been diagnosed with relapsing-remitting multiple sclerosis and for whom no suitable therapy exists i.e where existing therapies have failed. - generate additional safety and tolerability data, according to the label recommended by CHMP, in a population resembling that of future clinical practice.;Secondary Objective: ;Primary end point(s): The objective of this study is to provide early access to fingolimod to patients who have been diagnosed with relapsing-remitting multiple sclerosis for whom no suitable therapy exists (i.e. where existing therapies have failed) and to generate additional safety and tolerability data, according to the label recommended by CHMP, in a population resembling that of future clinical practice. For this reason, data analysis will simply be descriptive. No sample size calculation was performed. It is expected that approximately 600 patients will be enrolled during the planned duration of the trial. The actual number of enrolled patients may therefore differ from the planned one, based on the actual accrual rate in the various participating sites. | — |
Countries
Italy
Contacts
Public ContactMultiple Sclerosis Unit
Novartis Farma SpA
Outcome results
None listed