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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Examine the Difference in Tolerability Associated With Titration Of Dose on Initiation of Avonex therapY (TODAY)
- ClinicalTrials.gov ID
- NCT00574041
- Acronym / sponsor ID
- TODAY / AUS-8002
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Avonex, side effects, flu like symptoms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to poor recruitment
- Enrolment
- 19 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 14 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Interferon beta-1atitrated dose of Avonex |
| 2 | Active comparator | Drug: Interferon beta-1afull dose Avonex |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of clinically-definite relapsing-remitting multiple sclerosis
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interferon beta-1aAlso: Avonexinjected, once a week | Drug | 1, 2 |
Primary outcome
To assess the mean severity of episodes of FLS during the 4 week titration phase
Time frame: 4 weeks
1 secondary outcome
To assess the mean severity and duration of FLS episodes in post-titration phase
Time frame: throughout study
Results and safety
The study was stopped early (reason given: Terminated due to poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Biogen-Idec Investigator principal investigator
Biogen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Interferon beta-1a in people with Relapsing Remitting Multiple Sclerosis, run by Biogen at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Terminated due to poor recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the mean severity of episodes of FLS during the 4 week titration phase (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2008.