This was a multicentre, blinded, randomised, placebo-controlled trial of interferon beta-1b in patients with mild relapsing-remitting multiple sclerosis.
372 patients were recruited:
- mean age 35.5 years
- ambulatory
- mild disability (EDSS scores 0 - 5.5)
- short duration of definite MS (mean duration 4.4 years)
- duration of follow-up 3.5 to 5 years
The treatment arms consisted of:
- low dose - 1.6 MIU subcutaneously alternate days
- high dose - 8 MIU subcutaneously alternate days
The end-points were:
- relapse frequency
- disease burden on T2-weighted MRI scans of the brain
- confirmed disease progression
Reference:
- 1) The IFNB multiple sclerosis study group. (1993) Interferon beta-1b is effective in relapsing-remitting multiple sclerosis-I: clinical results of a multicentre, randomized, double-blind, placebo-controlled trial. Neurology, 43, 655-61
- 2) The IFNB multiple sclerosis study group and the University of British Columbia MS/MRI analysis group. (1995) Interferon beta-1b in the treatment of multiple sclerosis: final outcome of the randomized controlled trial. Neurology 45, 1277-85