The therapy with Interferon-ß-1b reduces the inflammatory component of multiple sclerosis with positive effects on the disease course. The 8 MUI dose at alternate days is kept constant for years. About 1/3 of patients suspend treatment by three years due to side effects or suspected or accepted ineffectiveness. The main objective of the study is to verify the safety and effectiveness of a cyclical administration (a month of suspension after two of treatment) from the beginning of treatment. There is the possibility that a scheme envisaging therapy free intervals can reduce the onset of negative feedbacks (antagonising the drug therapeutic effect) compared to the standard administration protocol. This might also result in an increase of the drug effectiveness and/or in a longer duration of effectiveness itself. Finally, cyclical administration allows patients to spend actual periods of "therapeutic vacation", with positive psychological effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
250 micrograms (8 MIU) administered subcutaneously (sc) every other day with a discontinuance month every 2 months
250 micrograms (8 MIU) administered subcutaneously (sc) every other day
Azienda Ospedaliera S. Andrea, II Facoltà di Medicina e Chirurgia, Università di Roma "La Sapienza"
Rome, Italy
number of gad-enhancing lesions (CELs) in T1
Group (cyclic withdrawal vs full regimen) differences in the cumulative number of CELs
Time frame: baseline and after 12 months
number of new and enlarging T2 lesions
Group (cyclic withdrawal vs full regimen) differences in new and enlarging T2 lesions
Time frame: baseline and after 12 months
volume of T1 lesions (black holes)
Group (cyclic withdrawal vs full regimen) differences in T1 lesion volume (black holes)
Time frame: baseline and after 12 months
relapse rate
Group (cyclic withdrawal vs full regimen) differences in relapse rate
Time frame: baseline and after 12 months
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