Conditions: Relapsing Remitting Multiple Sclerosis (RRMS)
Keywords: Relapsing remitting multiple sclerosis multiple sclerosis (MS) safety tolerability health outcomes fingolimod disease control MRI
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 142
Healthy volunteers: no

Brief summary:
This study evaluated disease control during different lengths of treatment transition from natalizumab to fingolimod.

Detailed description:
Patient were screened, signed an informed consent at visit 1, at the 2nd visit, all patient received a baseline infusion of Natalizumub and subsequently randomized to one of 3 treatment arms. At the randomization visit, the Washout Phase started, and eligible patients were randomized 1:1:1 to one of three treatment groups:

* 8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod,
* 12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod, or
* 16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod.

Arms:
arm 1: 8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day arm 2: 12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day arm 3: 16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day

Interventions: intervention 1: Fingolimod intervention 2: Placebo
Intervention descriptions: intervention 1: Fingolimod 0.5 mg capsules for oral administration once daily intervention 2: Matching placebo in capsules for oral administration once daily.

Protocol document: