Relapsing-Remitting Multiple SclerosisFITNCT00492570
GER-009-06-AVX Early Therapy in Multiple Sclerosis
An observational study of Relapsing-Remitting Multiple Sclerosis, run by Biogen.
Trial summary
This study is being done to increase awareness for early therapy with Avonex for Multiple Sclerosis (MS) and the cognitive dysfunction that accompanies MS, and to record safety data for Avonex. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Relapsing-Remitting Multiple Sclerosis
- How many people
- 230 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Dec 2008
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: multi-center using 150-200 neurologists and their patient populations.
Who may be able to join
- CIS (according to indication) or early Relapsing Remitting Multiple Sclerosis
Who cannot join
- treatment with DMT during the last 12 months
About this study
This study is being done to increase awareness for early therapy with Avonex for Multiple Sclerosis (MS) and the cognitive dysfunction that accompanies MS, and to record safety data for Avonex.
Read the detailed description
This study will address the cognitive dysfunction associated with MS. It will track these changes and show that early intervention with Avonex is effective in slowing MS and its effect on patients. Safety data will also be collected during this study.
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Cognitive Dysfunction in Multiple sclerosis, early treatment, Avonex, interferon beta 1a, Cognitive Dysfunction
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Cognitive Dysfunction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study startApr 2006
- Primary completionOct 2007
- Study completionDec 2008
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Biogen-Idec Study Director, Principal investigator, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00492570
- Sponsor's protocol ID
- GER-009-06-AVX
- Acronym
- FIT
- Status last verified
- Jun 2009
- First submitted
- 25 Jun 2007
- Last updated
- 16 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GER-009-06-AVX Early Therapy in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00492570
- Acronym / sponsor ID
- FIT / GER-009-06-AVX
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Cognitive Dysfunction in Multiple sclerosis, early treatment, Avonex, interferon beta 1a, Cognitive Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 27 Jun 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 being done to increase awareness for early therapy with Avonex for Multiple Sclerosis (MS) and the cognitive dysfunction that accompanies MS, and to record safety data for Avonex.
Detailed description
This study will address the cognitive dysfunction associated with MS. It will track these changes and show that early intervention with Avonex is effective in slowing MS and its effect on patients. Safety data will also be collected during this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- multi-center using 150-200 neurologists and their patient populations.
Key inclusion criteria (1 listed)
- CIS (according to indication) or early Relapsing Remitting Multiple Sclerosis
Key exclusion criteria (1 listed)
- treatment with DMT during the last 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2009.
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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 Study Director principal investigator
Biogen
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing-Remitting Multiple Sclerosis, run by Biogen.
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 1 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: finished, as of the sponsor's last update on 16 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 16 Jun 2009.