Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Written informed consent must be obtained before any assessment is performed.
Patients must be diagnosed with relapsing remitting MS (RRMS) as defined by 2005 revised McDonald criteria (McDonald et al 2001, Polman et al 2005) (Appendix 2).
Patients who explicitly agree to be assigned to a treatment group that may receive or DMT after having been informed about their respective benefits and possible adverse events by the investigator.
Male or female patients aged 18-70 years.
An Expanded Disability Status Scale (EDSS) score of 0-6 inclusive.
Must have received continuous treatment with a single approved and indicated MS DMT for a minimum of 6 months prior to the screening visit. Patients must continue with this MS DMT until the randomization visit.
Naïve to treatment with fingolimod.
A history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome.
History of malignancy of any organ system.
Diagnosis of macular edema during Screening Phase.
Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS or to have positive HIV antibody test.
Patients who have received any live or live attenuated vaccines (including for varicella-zoster virus or measles) within 2 months prior to baseline.
Patients who have received total lymphoid irradiation or bone marrow transplantation.
History of selected immune system treatments and/or medications.
Any medically unstable condition, as assessed by the investigator.
Selected cardiovascular, or hepatic conditions
Selected abnormal laboratory values.
Patients with any other disease or clinical condition (including neurologic or psychiatric disorders) which may affect patient enrollment into the study and study medication use by the Investigators' opinion.
Participation in any clinical research study evaluating another not approved in Russia investigational drug or therapy within 6 months prior to baseline.
History of hypersensitivity to the study drug or to drugs of similar chemical classes.
