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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00574041