Not Yet RecruitingPhase 4ACTRN12607000184471

Avonex dose titration study in Multiple Sclerosis

An open-label study to assess the severity of episodes of flu-like symptoms associated with Avonex therapy in patients with Multiple Sclerosis

Sponsor

Biogen Idec Australia Pty Ltd

Enrollment

90 participants

Start Date

May 1, 2007

Study Type

Interventional

Conditions

Multiple Sclerosis

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

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

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 Criteria1

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.

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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 (

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).