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Trial registered on ANZCTR


Registration number
ACTRN12607000184471
Ethics application status
Not yet submitted
Date submitted
27/03/2007
Date registered
29/03/2007
Date last updated
10/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Avonex dose titration study in Multiple Sclerosis
Scientific title
An open-label study to assess the severity of episodes of flu-like symptoms associated with Avonex therapy in patients with Multiple Sclerosis
Universal Trial Number (UTN)
Trial acronym
TODAY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 1702 0
Condition category
Condition code
Neurological 1794 1794 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will be randomised to either treatment or control groups. Total time on study for each subject will be 12 weeks.
Treatment group will initiate at 50% of approved dose of interferon beta-1a (Avonex) (15 micrograms once weekly) into the muscle for weeks one and two. They will then receive 75% of the approved dose (22.5 micrograms) for weeks three and four. Subjects will then switch to full dose therapy at week five (30 micrograms once weekly) and will receive this dose for a further eight weeks (weeks 5-12 inclusive).
Intervention code [1] 1672 0
Treatment: Drugs
Comparator / control treatment
Control group will initiate interferon beta-1a (Avonex) into the muscle at full dose (30 micrograms once weekly) from the outset and will be monitored for twelve weeks.
Control group
Active

Outcomes
Primary outcome [1] 2514 0
To assess the average severity of episodes of flu-like symptoms during the 4 week titration phase.
Timepoint [1] 2514 0
Flu-like symptoms will be recorded daily by participants, and reviewed weekly during the first 4 weeks of study by study nurses
Secondary outcome [1] 4328 0
To assess the mean duration of episodes of flu-like symptoms
Timepoint [1] 4328 0
During the 4 week titration phase (monitored weeksly during this time).
Secondary outcome [2] 4329 0
To assess the mean severity and duration of flu-like symptoms episodes during the post-titration phase.
Timepoint [2] 4329 0
5-12 weeks (monitored once at the end of week 12).
Secondary outcome [3] 4330 0
To assess the number of episodes of flu-like symptoms post-injection during post-titration phase.
Timepoint [3] 4330 0
Monitored once at the end of week 12.
Secondary outcome [4] 4331 0
To assess the number of episodes of flu-like symptoms post-injection during titration phase.
Timepoint [4] 4331 0
Monitored once at the end of week 12.
Secondary outcome [5] 4332 0
To assess the use of anti-pyretic medication for flu-like symptom control during titration phase.
Timepoint [5] 4332 0
Monitored weekly during weeks 1-5.

Eligibility
Key inclusion criteria
Clinically definite Relapsing-Remitting Multiple Sclerosis (RRMS) who are ambulatory, able and willing to use liquid AVONEX® (hereafter to be referred to as AVONEX) formulation and who have consented to participate in this study.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects will be excluded if they have contraindications to interferon-beta therapy, or other significant medical conditions which, in the opinion of the PI would exclude the subject from participating, including clinically infectious illnesses within 30 days prior to randomisation. Subjects who have previously, or are currently, receiving interferon-beta therapy are eligible for this study provided they have not received AVONEX therapy within 3 months prior to randomisation.

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)
Allocation of treatment is random and is concealed by way of sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using procedures such as coin-tossing and dice-rolling
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1946 0
Commercial sector/Industry
Name [1] 1946 0
Biogen Idec Australia Pty Ltd
Country [1] 1946 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Biogen Idec Australia Pty Ltd
Address
Country
United States of America
Secondary sponsor category [1] 1759 0
None
Name [1] 1759 0
Nil
Address [1] 1759 0
Country [1] 1759 0

Ethics approval
Ethics application status
Not yet submitted

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27775 0
Address 27775 0
Country 27775 0
Phone 27775 0
Fax 27775 0
Email 27775 0
Contact person for public queries
Name 10861 0
Dr Stephen Blair
Address 10861 0
Biogen Idec Australia Pty Ltd
Suite 2, Level 4
123 Epping Road
North Ryde NSW 2113
Country 10861 0
Australia
Phone 10861 0
+61 2 88753908
Fax 10861 0
+61 2 98891162
Email 10861 0
[email protected]
Contact person for scientific queries
Name 1789 0
Dr Stephen Blair
Address 1789 0
Biogen Idec Australia Pty Ltd
Suite 2
Level 4
123 Epping Road
North Ryde NSW 2113
Country 1789 0
Australia
Phone 1789 0
+61 2 88753908
Fax 1789 0
+61 2 98891162
Email 1789 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.