Multiple Sclerosis15yASSURANCENCT00525343
Avonex 15 Year Long Term Follow-up Study
An observational study of Multiple Sclerosis, run by Biogen at 4 sites in United States.
Trial summary
The Avonex Fifteen-year Long-term Follow-up of Patients with Relapsing Multiple Sclerosis: ASSessment of Drug Utilization, EaRly TreAtmeNt, and Clinical OutcomEs (ASSURANCE), was a single-time-point evaluation of patients conducted 15 years after the pivotal MSCRG study, evaluated the impact of IM IFNβ-1a treatment on… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 122 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2007to Sep 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients having completed at least 2 years of treatment (Avonex® or placebo) in the original Avonex® pivotal trial.
Who may be able to join
- Patients having completed at least 2 years of treatment (Avonex® or placebo) in the original Avonex® pivotal trial.
- Subjects (or their caregivers) must be willing to complete a multi-page questionnaire.
- Signed written informed consent form
Who cannot join
- Unwillingness or inability to comply with the requirements of this protocol.
- Any other reasons that, in the opinion of the Investigator, the subject is determined to be unsuitable for enrollment into this study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Jocab's Neurological Institute
Buffalo, New York, 14203
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Oregon Health and Science University
Portland, Oregon, 97239
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
About this study
Official title: Avonex® Fifteen Year Long Term Follow Up of Patients With Relapsing Multiple Sclerosis: ASSessment of Drug Utilization, EaRly TreAtmeNt, and Clinical OutcomEs
The Avonex Fifteen-year Long-term Follow-up of Patients with Relapsing Multiple Sclerosis: ASSessment of Drug Utilization, EaRly TreAtmeNt, and Clinical OutcomEs (ASSURANCE), was a single-time-point evaluation of patients conducted 15 years after the pivotal MSCRG study, evaluated the impact of IM IFNβ-1a treatment on long-term disability and Quality of Life outcomes in patients who completed 2 years in a previous Multiple Sclerosis Collaborative Research Group (MSCRG) study.
Read the detailed description
The primary objective of this study is to determine the impact of early versus delayed initiation of treatment on the long-term physical status of patients with relapsing forms of MS measured by the self-reported EDSS.
Primary endpoints for this study were as follows:
- Changes in EDSS score from baseline for original Avonex® pivotal trial
- Percentage of patients with EDSS scores less than or equal to 4
- Percentage of patients with EDSS scores less than or equal to 6
- Percentage of patients with EDSS scores less than or equal to 7
Secondary endpoints were:
- Percentage of patients alive
- Percentage of patients living independently
- SF 36 Quality of Life status
- Self-reported VAS of independence with self-care
- Conditions
- Multiple Sclerosis
- Keywords
- Avonex pivotal trial, Avonex, Avonex long term follow-up, Avonex outcomes
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the impact of early versus delayed initiation of treatment on the long-term disability status of patients with relapsing forms of multiple sclerosis (MS) measured by the self-reported EDSS.
Measured: 15 years
Secondary outcomes (1)
To determine the impact of early versus delayed initiation of treatment on patients' mortality, living independence, and quality of life.
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2007 (estimated)
- Study startMar 2007
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Retrospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pamela Foulds, MD, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525343
- Sponsor's protocol ID
- 007-06-AVX
- Acronym
- 15yASSURANCE
- Status last verified
- Mar 2010
- First submitted
- 4 Sep 2007
- Last updated
- 8 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avonex® Fifteen Year Long Term Follow Up of Patients With Relapsing Multiple Sclerosis: ASSessment of Drug Utilization, EaRly TreAtmeNt, and Clinical OutcomEs
- ClinicalTrials.gov ID
- NCT00525343
- Acronym / sponsor ID
- 15yASSURANCE / 007-06-AVX
- Conditions
- Multiple Sclerosis
- Keywords
- Avonex pivotal trial, Avonex, Avonex long term follow-up, Avonex outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Study completion
- Sep 2008 (actual)
- First posted
- 5 Sep 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.
The Avonex Fifteen-year Long-term Follow-up of Patients with Relapsing Multiple Sclerosis: ASSessment of Drug Utilization, EaRly TreAtmeNt, and Clinical OutcomEs (ASSURANCE), was a single-time-point evaluation of patients conducted 15 years after the pivotal MSCRG study, evaluated the impact of IM IFNβ-1a treatment on long-term disability and Quality of Life outcomes in patients who completed 2 years in a previous Multiple Sclerosis Collaborative Research Group (MSCRG) study.
Detailed description
The primary objective of this study is to determine the impact of early versus delayed initiation of treatment on the long-term physical status of patients with relapsing forms of MS measured by the self-reported EDSS.
Primary endpoints for this study were as follows:
- Changes in EDSS score from baseline for original Avonex® pivotal trial
- Percentage of patients with EDSS scores less than or equal to 4
- Percentage of patients with EDSS scores less than or equal to 6
- Percentage of patients with EDSS scores less than or equal to 7
Secondary endpoints were:
- Percentage of patients alive
- Percentage of patients living independently
- SF 36 Quality of Life status
- Self-reported VAS of independence with self-care
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having completed at least 2 years of treatment (Avonex® or placebo) in the original Avonex® pivotal trial.
Key inclusion criteria (3 listed)
- Patients having completed at least 2 years of treatment (Avonex® or placebo) in the original Avonex® pivotal trial.
- Subjects (or their caregivers) must be willing to complete a multi-page questionnaire.
- Signed written informed consent form
Key exclusion criteria (2 listed)
- Unwillingness or inability to comply with the requirements of this protocol.
- Any other reasons that, in the opinion of the Investigator, the subject is determined to be unsuitable for enrollment into this study
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
To determine the impact of early versus delayed initiation of treatment on the long-term disability status of patients with relapsing forms of multiple sclerosis (MS) measured by the self-reported EDSS.
Time frame: 15 years
1 secondary outcome
To determine the impact of early versus delayed initiation of treatment on patients' mortality, living independence, and quality of life.
Time frame: 15 years
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 8 Mar 2010.
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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.
Pamela Foulds, MD study director
Biogen
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Biogen at 4 sites in United States.
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 3 inclusion and 2 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 8 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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.
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.
What does the primary outcome measure?
To determine the impact of early versus delayed initiation of treatment on the long-term disability status of patients with relapsing forms of multiple sclerosis (MS) measured by the self-reported EDSS. (time frame: 15 years). 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 8 Mar 2010.