Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00574041




Registration number
NCT00574041
Ethics application status
Date submitted
12/12/2007
Date registered
14/12/2007
Date last updated
4/09/2008

Titles & IDs
Public title
How Side Effects of Avonex Are Affected by Gradually Increasing to Full Dose vs Starting at Full Dose
Scientific title
An Open-Label Study to Examine the Difference in Tolerability Associated With Titration Of Dose on Initiation of Avonex therapY (TODAY)
Secondary ID [1] 0 0
AUS-8002
Universal Trial Number (UTN)
Trial acronym
TODAY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsing Remitting Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Interferon beta-1a

Experimental: 1 - titrated dose of Avonex

Active comparator: 2 - full dose Avonex


Treatment: Drugs: Interferon beta-1a
injected, once a week
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To assess the mean severity of episodes of FLS during the 4 week titration phase
Timepoint [1] 0 0
4 weeks
Secondary outcome [1] 0 0
To assess the mean severity and duration of FLS episodes in post-titration phase
Timepoint [1] 0 0
throughout study

Eligibility
Key inclusion criteria
* Diagnosis of clinically-definite relapsing-remitting multiple sclerosis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2008
Sample size
Target
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Coordinating Research Site - Malvern
Recruitment postcode(s) [1] 0 0
3144 - Malvern

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biogen
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00574041
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Biogen-Idec Investigator
Address 0 0
Biogen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00574041