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
Patients must be diagnosed with relapsing remitting MS (RRMS) as defined by 2005 revised McDonald criteria.
Patients who explicitly agree to be assigned to a treatment group that may receive fingolimod or DMT after having been informed about their respective benefits and possible adverse events by the investigator.
An Expanded Disability Status Scale (EDSS) score of 0-5.5 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 (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
Patients with uncontrolled diabetes mellitus (HbA1c \> 7%).
Diagnosis of macular edema during Screening Phase.
