Back to resultsHow Side Effects of Avonex Are Affected by Gradually Increasing to Full Dose vs Starting at Full Dose (TODAY)
Primary Purpose
Relapsing Remitting Multiple Sclerosis
Status
Terminated
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Interferon beta-1a
Sponsored by
About this trial
This is an interventional treatment trial for Relapsing Remitting Multiple Sclerosis focused on measuring Multiple Sclerosis, Avonex, side effects, flu like symptoms
Eligibility 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
Sites / Locations
- Coordinating Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
titrated dose of Avonex
full dose Avonex
Outcomes
Primary Outcome Measures
To assess the mean severity of episodes of FLS during the 4 week titration phase
Secondary Outcome Measures
To assess the mean severity and duration of FLS episodes in post-titration phase
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00574041
Brief Title
How Side Effects of Avonex Are Affected by Gradually Increasing to Full Dose vs Starting at Full Dose
Acronym
TODAY
Official Title
An Open-Label Study to Examine the Difference in Tolerability Associated With Titration Of Dose on Initiation of Avonex therapY (TODAY)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to poor recruitment
Study Start Date
June 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Biogen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Remitting Multiple Sclerosis
Keywords
Multiple Sclerosis, Avonex, side effects, flu like symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
titrated dose of Avonex
Arm Title
2
Arm Type
Active Comparator
Arm Description
full dose Avonex
Intervention Type
Drug
Intervention Name(s)
Interferon beta-1a
Other Intervention Name(s)
Avonex
Intervention Description
injected, once a week
Primary Outcome Measure Information:
Title
To assess the mean severity of episodes of FLS during the 4 week titration phase
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
To assess the mean severity and duration of FLS episodes in post-titration phase
Time Frame
throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Biogen-Idec Investigator
Organizational Affiliation
Biogen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Coordinating Research Site
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
12. IPD Sharing Statement
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How Side Effects of Avonex Are Affected by Gradually Increasing to Full Dose vs Starting at Full Dose
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