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

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ClinicalTrials.gov Identifier: NCT00574041
Recruitment Status : Terminated (Terminated due to poor recruitment)
First Posted : December 14, 2007
Last Update Posted : September 4, 2008
Sponsor:
Information provided by:
Biogen

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.

Condition or disease Intervention/treatment Phase
Relapsing Remitting Multiple Sclerosis Drug: Interferon beta-1a Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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)
Study Start Date : June 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. To assess the mean severity of episodes of FLS during the 4 week titration phase [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. To assess the mean severity and duration of FLS episodes in post-titration phase [ Time Frame: throughout study ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00574041


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

Responsible Party: Biogen Idec MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00574041     History of Changes
Other Study ID Numbers: AUS-8002
First Posted: December 14, 2007    Key Record Dates
Last Update Posted: September 4, 2008
Last Verified: September 2008

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

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