How Side Effects of Avonex Are Affected by Gradually Increasing to Full Dose vs Starting at Full Dose

An Open-Label Study to Examine the Difference in Tolerability Associated With Titration Of Dose on Initiation of Avonex therapY (TODAY)

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00574041

Acronym

TODAY

Enrollment

Registered

2007-12-14

Start date

2007-06-30

Completion date

2008-02-29

Last updated

2008-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

Multiple Sclerosis, Avonex, side effects, flu like symptoms

Brief summary

This study is to find out if starting at low dose Avonex and slowly increasing to full dose will improve flu like symptoms as a side effect of Avonex treatment.

Interventions

DRUGInterferon beta-1a

injected, once a week

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of clinically-definite relapsing-remitting multiple sclerosis

Exclusion criteria

* Any Product Information-specified contraindications to interferon-beta therapy, or other medical factors which, in the opinion of the investigator, make the subject unsuitable for interferon-beta therapy * Use of AVONEX, but not other interferon therapies, in the 3 months prior to randomisation into the study * A clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to randomisation. * History of seizure in the 3 months prior to randomisation * History of suicidal ideation or severe depression within the 3 months prior to randomisation. * Other inclusion and

Design outcomes

Primary

Measure	Time frame
To assess the mean severity of episodes of FLS during the 4 week titration phase	4 weeks

Secondary

Measure	Time frame
To assess the mean severity and duration of FLS episodes in post-titration phase	throughout study

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026