Relapsing Remitting Multiple SclerosisPhase 4TODAYNCT00574041
How Side Effects of Avonex Are Affected by Gradually Increasing to Full Dose vs Starting at Full Dose
A Phase 4 study testing Interferon beta-1a in people with Relapsing Remitting Multiple Sclerosis, run by Biogen at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- Interferon beta-1a
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 2007to Feb 2008
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of clinically-definite relapsing-remitting multiple sclerosis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Study to Examine the Difference in Tolerability Associated With Titration Of Dose on Initiation of Avonex therapY (TODAY)
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.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- Interferon beta-1a
- Keywords
- Multiple Sclerosis, Avonex, side effects, flu like symptoms
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon beta-1aDrug
Also called Avonex
injected, once a week
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | titrated dose of Avonex Receives: Drug: Interferon beta-1a |
| 2 | Active comparator | full dose Avonex Receives: Drug: Interferon beta-1a |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the mean severity of episodes of FLS during the 4 week titration phase
Measured: 4 weeks
Secondary outcomes (1)
To assess the mean severity and duration of FLS episodes in post-titration phase
Measured: throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2007 (estimated)
- Study startJun 2007
- Primary completionFeb 2008
- Study completionFeb 2008
Why it stopped: Terminated due to poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Biogen-Idec Investigator, Principal investigator, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00574041
- Sponsor's protocol ID
- AUS-8002
- Acronym
- TODAY
- Status last verified
- Sep 2008
- First submitted
- 12 Dec 2007
- Last updated
- 4 Sep 2008
- Results posted
- No
- Data monitoring committee
- No