Natalizumab De-escalation to Interferon-beta-1b in Patients With Relapsing-remitting Multiple Sclerosis
Status:
Terminated
Trial end date:
2013-10-01
Target enrollment:
Participant gender:
Summary
Multiple Sclerosis (MS) is the most common neurological disorder causing disability in young
adults affecting approximately 1 in 1.000 people in western countries. The clinical
manifestations usually begin at the age of 20 to 40 years with a median age of 28 years at
onset with acute episodes of neurological dysfunction, followed by periods of partial or
complete remission and clinical stability in between relapses. This relapsing-remitting phase
(RR-MS) of the disease is usually followed by progressive clinical disability (secondary
progressive phase, SP-MS).
At present, there is no cure for MS. Based on the pathological concept that neuroinflammation
is the common element leading or contributing to neurodegenerative changes, immune
interventions have been introduced into clinical practice such as Natalizumab (Tysabri), a
humanized monoclonal antibody. Natalizumab (Tysabri) is indicated as a disease-modifying
monotherapy of highly active relapsing MS. The associated risks, especially progressive
multifocal leukoencephalopathy, necessitate active monitoring of patients and a continuous
discussion of optimum use of this drug. In clinical practice, the question how to manage
patients on natalizumab at a higher risk for progressive multifocal leukoencephalopathy
remains unresolved.
This prospective, controlled (comparison to the period prior to natalizumab treatment),
single-arm, open-label, multi-centre, phase IV study aims to evaluating the concept of
natalizumab de-escalation to interferon-beta-1b e.o.d in relapsing-remitting multiple
sclerosis patients, who consider stopping natalizumab due to a benefit-risk assessment. In
particular, to evaluating if interferon beta-1b treatment may be able to overcome the
recurrence of significant clinical and radiological disease activity after natalizumab
cessation and may keep disease activity better under control as compared to the time prior to
natalizumab.
The study population includes patients with relapsing-remitting multiple sclerosis (RR-MS)
being treated at least for 12 months with natalizumab and having decided to stop natalizumab
treatment and to de-escalate their therapy to a first line treatment with interferon beta-1b.
They will be treated during 12 months with interferon-beta 1b 250 mcg given subcutaneously
every other day. A 12-month follow-up period with the same treatment is planned.