None listed
Conditions
Brief summary
This study is intended to investigate whether starting at a fraction of the full dose of interferon beta-1a (Avonex) treatment for relapsing and remitting Multiple Sclerosis and increasing up to the full dose over a month produces fewer flu-like symptoms than starting at the full dose of the same treatment
Interventions
Subjects will be randomised to either treatment or control groups. Total time on study for each subject will be 12 weeks.
Treatment group will initiate at 50% of approved dose of interferon beta-1a (Avonex) (15 micrograms once weekly) into the muscle for weeks one and two. They will then receive 75% of the approved dose (22.5 micrograms) for weeks three and four. Subjects will then switch to full dose therapy at week five (30 micrograms once weekly) and will receive this dose for a further eight
Subjects will be randomised to either treatment or control groups. Total time on study for each subject will be 12 weeks. Treatment group will initiate at 50% of approved dose of interferon beta-1a (Avonex) (15 micrograms once weekly) into the muscle for weeks one and two. They will then receive 75% of the approved dose (22.5 micrograms) for weeks three and four. Subjects will then switch to full dose therapy at week five (30 micrograms once weekly) and will receive this dose for a further eight weeks (weeks 5-12 inclusive).
Sponsors
Biogen Idec Australia Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Clinically definite Relapsing-Remitting Multiple Sclerosis (RRMS) who are ambulatory, able and willing to use liquid AVONEX® (hereafter to be referred to as AVONEX) formulation and who have consented to participate in this study.
Exclusion criteria
Subjects will be excluded if they have contraindications to interferon-beta therapy, or other significant medical conditions which, in the opinion of the PI would exclude the subject from participating, including clinically infectious illnesses within 30 days prior to randomisation. Subjects who have previously, or are currently, receiving interferon-beta therapy are eligible for this study provided they have not received AVONEX therapy within 3 months prior to randomisation.
Outcome results
None listed