Multiple SclerosisNCT01031459
Telephone Interview of Patients That Participated in the the Pivotal Betaferon MS Trial.
An observational study of Multiple Sclerosis, run by Bayer at 10 sites in 2 countries.
Trial summary
The purpose of this study is to investigate the clinical status of patients who participated in the original pivotal Betaseron study at 20 years after randomized treatment initiationStudy end-points include: 1. Mortality - All-cause mortality - Cause specific mortality - Multiple sclerosis-related mortality 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Betaseron (Interferon beta-1b, BAY86-5046)
- How many people
- 176 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Jan 2010to Dec 2010
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with MS that participated in the 16Y-LTF and Pivitol studies
Who may be able to join
- Previously enrolled in the Betaseron pivotal study protocols TB01-35686 in the US and TB01-35886 in Canada (total, N=372)
- Patient, caregiver, or legal guardian must provide written informed consent
- Patient must confirm her/his ability and agreement to participate in the study at the beginning of the phone call
Who cannot join
None listed.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States6 sites
Study site
Baltimore, Maryland, 21201
Study site
Birmingham, Alabama, 35249
Study site
Chicago, Illinois, 60637-1470
Study site
Philadelphia, Pennsylvania, 19107
Study site
San Francisco, California, 94117
Study site
Tucson, Arizona, 85741-3537
Canada4 sites
Study site
London, Ontario, N6A 5A5
Study site
Montreal, Quebec, H2L 4M1
Study site
Montreal, Quebec, H3A 2B4
Study site
Vancouver, British Columbia, V6T 2B5
About this study
Official title: An Observational 20-year, Cross-sectional, Long-term Follow up of the Patient Cohort Enrolled in the Pivotal Study of Betaseron® (Interferon Beta-1b) in Relapsing-remitting Multiple Sclerosis
The purpose of this study is to investigate the clinical status of patients who participated in the original pivotal Betaseron study at 20 years after randomized treatment initiationStudy end-points include:
- Mortality - All-cause mortality - Cause specific mortality - Multiple sclerosis-related mortality
- EDSS (Expanded Disability Status Scale)
- Cognition
- Resource use
- SPMS (Secondary Progressive Multiple Sclerosis) status
- Employment history
- Conditions
- Multiple Sclerosis
- Being tested
- Betaseron (Interferon beta-1b, BAY86-5046)
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Betaseron (Interferon beta-1b, BAY86-5046)Drug
Telephone survey of all patients.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Betaseron (Interferon beta-1b, BAY86-5046) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive exploration of mortality, EDSS, cognition, resource use, SPMS status and employment history by length of exposure to Betaseron and stratified by the original clinical trial group assignment (1.6 MIU, 8 MIU, placebo)
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionDec 2010
- Study completionDec 2010
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 BayerThe 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
- Cross-sectional
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01031459
- Sponsor's protocol ID
- 14261
- Other IDs
- 20Y-LTF
- Status last verified
- Jan 2012
- First submitted
- 8 Dec 2009
- Last updated
- 5 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational 20-year, Cross-sectional, Long-term Follow up of the Patient Cohort Enrolled in the Pivotal Study of Betaseron® (Interferon Beta-1b) in Relapsing-remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01031459
- Acronym / sponsor ID
- 14261
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 14 Dec 2009 (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 purpose of this study is to investigate the clinical status of patients who participated in the original pivotal Betaseron study at 20 years after randomized treatment initiationStudy end-points include:
- Mortality - All-cause mortality - Cause specific mortality - Multiple sclerosis-related mortality
- EDSS (Expanded Disability Status Scale)
- Cognition
- Resource use
- SPMS (Secondary Progressive Multiple Sclerosis) status
- Employment history
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Betaseron (Interferon beta-1b, BAY86-5046) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with MS that participated in the 16Y-LTF and Pivitol studies
Key inclusion criteria (3 listed)
- Previously enrolled in the Betaseron pivotal study protocols TB01-35686 in the US and TB01-35886 in Canada (total, N=372)
- Patient, caregiver, or legal guardian must provide written informed consent
- Patient must confirm her/his ability and agreement to participate in the study at the beginning of the phone call
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Betaseron (Interferon beta-1b, BAY86-5046)Telephone survey of all patients. | Drug | Group 1 |
Primary outcome
Descriptive exploration of mortality, EDSS, cognition, resource use, SPMS status and employment history by length of exposure to Betaseron and stratified by the original clinical trial group assignment (1.6 MIU, 8 MIU, placebo)
Time frame: 20 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 5 Jan 2012.
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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.
Bayer Study Director study director
Bayer
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Bayer at 10 sites in 2 countries.
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 0 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 5 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada. 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?
Descriptive exploration of mortality, EDSS, cognition, resource use, SPMS status and employment history by length of exposure to Betaseron and stratified by the original clinical trial group assignment (1.6 MIU, 8 MIU, placebo) (time frame: 20 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 5 Jan 2012.