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

Information source: Biogen
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Relapsing Remitting Multiple Sclerosis

Intervention: Interferon beta-1a (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Biogen-Idec Investigator, Principal Investigator, Affiliation: Biogen

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: To assess the mean severity of episodes of FLS during the 4 week titration phase

Secondary outcome: To assess the mean severity and duration of FLS episodes in post-titration phase

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Coordinating Research Site, Malvern, Victoria 3144, Australia
Additional Information

Starting date: June 2007
Last updated: September 2, 2008

Page last updated: August 20, 2015

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