Multiple Sclerosis (MS) is the most common neurological disorder causing disability in young
adults. The management of MS-patients requires treatment with disease-modifying agents,
monoclonal antibodies such as natalizumab or immunosuppressants. Natalizumab showed good
efficacy and is approved for treatment of relapsing MS with a number of restrictions due to
safety issues. Cognitive data related to natalizumab treatment are still scarce.
Interferon-beta-1b is approved for high-frequency, subcutaneous (sc) administration in the
treatment of multiple sclerosis. It reduces the relapse rate, severity, hospitalisation and
the disease activity as seen on MRI.
This is a pilot study to explore the concept of de-escalating natalizumab treatment to
interferon-beta-1b e.o.d compared to continuous treatment with natalizumab in patients with
relapsing-remitting multiple sclerosis previously treated with natalizumab for 12 months. The
study is designed as prospective, controlled, randomized, rater-blinded, parallel-group, two
arm, mono-centric including patients of the Ticino Cohort. One arm will be treated with
Interferon-beta 1b 250mcg given subcutaneously every other day, the other with Natalizumab
300 mg given intravenously (i.v.), every four weeks. The treatment duration is 12 months, the
follow-up period 12 months. The time to first on-study relapse will be compared between the
to treatment arms (primary outcome). Other efficacy parameter include clinical and
radiological parameters, patient reported outcome on quality of life and fatigue. Safety is
assessed by reports of adverse events.