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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014