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

This study has been terminated.
(Terminated due to poor recruitment)
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00574041
First received: December 12, 2007
Last updated: September 2, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention Phase
Relapsing Remitting Multiple Sclerosis
Drug: Interferon beta-1a
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: An Open-Label Study to Examine the Difference in Tolerability Associated With Titration Of Dose on Initiation of Avonex therapY (TODAY)

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • To assess the mean severity of episodes of FLS during the 4 week titration phase [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess the mean severity and duration of FLS episodes in post-titration phase [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]

Enrollment: 19
Study Start Date: June 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
titrated dose of Avonex
Drug: Interferon beta-1a
injected, once a week
Other Name: Avonex
Active Comparator: 2
full dose Avonex
Drug: Interferon beta-1a
injected, once a week
Other Name: Avonex

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00574041

Locations
Australia, Victoria
Coordinating Research Site
Malvern, Victoria, Australia, 3144
Sponsors and Collaborators
Biogen Idec
Investigators
Principal Investigator: Biogen-Idec Investigator Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00574041     History of Changes
Other Study ID Numbers: AUS-8002
Study First Received: December 12, 2007
Last Updated: September 2, 2008
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Biogen Idec:
Multiple Sclerosis
Avonex
side effects
flu like symptoms

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon-beta
Interferons
Interferon beta 1a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on April 17, 2014