CFTY720D2324 Tysabri Switch Study

• Research type

  Research Study

• Full title

  A 32-week, patient- and rater-blinded, randomized, multi-center, parallel-group study to evaluate disease control and safety in patients with relapsing remitting multiple sclerosis transferred from previous treatment with natalizumab to fingolimod (FTY720)

• IRAS ID

  78808

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2011-001442-15

• ISRCTN Number

  n/a

• Research summary

  Multiple Sclerosis (MS) is the most common disabling disease of the Central Nervous System (brain and nerves of the spinal cord) in young adults.The cause of MS is unknown. It is an autoimmune disease, where the white blood cells (lymphocytes) start to attack the nerves and parts of the brain.There are several types of MS the most common type is known as relapsing remitting MS (RRMS). Patients withRRMS have repeated acute episodes of neurological symptoms (relapses), which are followed by a complete or partial recovery (remission).Fingolimod (FTY720 the study drug) is a new treatment for highly active RRMS is taken once daily as a capsule. Fingolimod acts on white bloods cells responsible for immune reactions and make cells move away from the sites of inflammation. These white blood cells are redirected to the lymph nodes and other places where they normally rest.Natalizumab is an approved second line disease modifying drug for the treatment of rapidy evolving severe RRMS. A rare side effect of treatment with Natalizumab is progressive multifocoal leucoencephalopathy (PML) caused by reactivation of latent JC Virus. Risk of PML upon treatment with Natalizumab increases over time. Many patients who are currently being treated with Natalizumab, as well as their physicians are looking for alternative MS treatments, fingolimod being one. The main purpose of this study is to measure how safe it is to transition patients from Natalizumab to fingolimod treatment during three different wash out periods following cessation of Natalizumab treatment. Each patient who signs consent and meets inclusion criteria will undergo examinations to determine that they are eligible to join the study. All patients who enter the study will receive active study medication following a placebo controlled washout period. Each patient will visit the clinic 8 times over a period of 32 weeks.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  11/SC/0246

• Date of REC Opinion

  14 Jul 2011

• REC opinion

  Favourable Opinion