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

Biogen

Status and phase: Terminated; Phase 4

Conditions: Relapsing Remitting Multiple Sclerosis

Treatments: Drug: Interferon beta-1a

Study type: Interventional

Funder types: Industry

Identifiers

NCT00574041

AUS-8002

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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 exclusion criteria may apply per study protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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19 participants in 2 patient groups

1

Experimental group

Description:

titrated dose of Avonex

Treatment:

Drug: Interferon beta-1a

2

Active Comparator group

Description:

full dose Avonex

Treatment:

Drug: Interferon beta-1a