Multiple Sclerosis, Relapsing-RemittingROBUSTNCT01158183
Real-World Betaseron Health Economic Outcomes Study for Relapsing Forms of Multiple Sclerosis
An observational study of Multiple Sclerosis, Relapsing-Remitting, run by Bayer at 27 sites in United States.
Trial summary
A Web based real world observational study in Relapsing-Remitting Multiple Sclerosis (RRMS) population capturing outcomes reported by patients and by the physicians during 12 months after initiating or resuming Betaseron. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- BAY86-5046_Interferon-beta-1b
- How many people
- 226 participants
- Where
- 27 sitesUnited States
- Study dates
- Jul 2007to Sep 2009
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: "real world" population
Who may be able to join
- Provides written informed consent to participate in the study
- At least 18 but no more than 65 years old
- Documented clinical diagnosis of a relapsing form of multiple sclerosis or confirmed clinically isolated syndrome (CIS)
- Initiating Betaseron therapy, or resuming Betaseron after not having used it for at least three months
- Willing and able to provide a valid e-mail address which will be in use for the duration of the study
- Willing and able to complete study questionnaires via the Internet
- Has reliable Internet access for the duration of the study
- Completes the baseline patient questionnaire
Who cannot join
- Kurtzke Expanded Disability Status Scale (EDSS) score greater than 6.0
- Cognitive dysfunction that, in the Investigator's judgment, raises doubts about the study participant's ability to provide informed consent or accurately complete the monthly patient questionnaire
- Any use of Betaseron within the three months prior to study entry
- Inability to read, write, or speak the English language
- Illness or disease other than multiple sclerosis that the Investigator believes is likely to cause the patient's death or incapacity within twelve months
- Any severe, uncontrolled illness or condition that the Investigator believes could dominate the patient's quality of life
Show all 11Show fewer
- Coexistent autoimmune disease such as rheumatoid arthritis, lupus, or psoriasis that is likely to be exacerbated by treatment with Interferon
- Current use of any immunosuppressive medication
- Previous participation in a multiple sclerosis (MS) clinical trial within the three months prior to study entry
- Previous use of monoclonal antibodies treating MS within the three months prior to study entry
- Current use of any secondary treatment for multiple sclerosis other than the episodic use of steroids during relapses or exacerbations
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Study site
Many Locations, Alabama
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Many Locations, California
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Many Locations, Colorado
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Many Locations, Florida
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Many Locations, Illinois
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Many Locations, Iowa
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Many Locations, Kansas
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Many Locations, Louisiana
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Many Locations, Maine
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Many Locations, Massachusetts
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Many Locations, Michigan
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Many Locations, Missouri
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Many Locations, Nevada
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Many Locations, New Hampshire
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Many Locations, New Jersey
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Many Locations, New York
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Many Locations, North Carolina
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Many Locations, North Dakota
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Many Locations, Ohio
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Many Locations, Oregon
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Many Locations, Pennsylvania
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Many Locations, Rhode Island
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Many Locations, Tennessee
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Many Locations, Texas
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Many Locations, Virginia
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Many Locations, Washington
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Many Locations, Wisconsin
About this study
Official title: Real-World Betaseron® Outcomes Study (ROBUST): A Twelve-month, US Prospective, Observational, Open-label, Single-arm, Multi-center Outcomes Study of Interferon β-1b (Betaseron®) Given Every Other Day for Relapsing Forms of Multiple Sclerosis
A Web based real world observational study in Relapsing-Remitting Multiple Sclerosis (RRMS) population capturing outcomes reported by patients and by the physicians during 12 months after initiating or resuming Betaseron.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- BAY86-5046_Interferon-beta-1b
- Keywords
- Outcomes, real world and web tool, electronic data capture
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY86-5046_Interferon-beta-1bDrug
Electronic questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | No intervention Receives: Drug: BAY86-5046_Interferon-beta-1b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Key Objective: To collect patient reported outcomes and clinical assessments via the same web-based data capture tool in a real world setting in relapse-remitting multiple sclerosis patients
Measured: Baseline, 1 to12 month outcome questionnaires
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study startJul 2007
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies 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
- Prospective
- Enrolment
- 226 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
- NCT01158183
- Sponsor's protocol ID
- 14838
- Other IDs
- BF0714US, 311644
- Acronym
- ROBUST
- Status last verified
- Jul 2010
- First submitted
- 7 Jul 2010
- Last updated
- 8 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Betaseron® Outcomes Study (ROBUST): A Twelve-month, US Prospective, Observational, Open-label, Single-arm, Multi-center Outcomes Study of Interferon β-1b (Betaseron®) Given Every Other Day for Relapsing Forms of Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01158183
- Acronym / sponsor ID
- ROBUST / 14838
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Outcomes, real world and web tool, electronic data capture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 8 Jul 2010 (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.
A Web based real world observational study in Relapsing-Remitting Multiple Sclerosis (RRMS) population capturing outcomes reported by patients and by the physicians during 12 months after initiating or resuming Betaseron.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: BAY86-5046_Interferon-beta-1bNo intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- "real world" population
Key inclusion criteria (8 listed)
- Provides written informed consent to participate in the study
- At least 18 but no more than 65 years old
- Documented clinical diagnosis of a relapsing form of multiple sclerosis or confirmed clinically isolated syndrome (CIS)
- Initiating Betaseron therapy, or resuming Betaseron after not having used it for at least three months
- Willing and able to provide a valid e-mail address which will be in use for the duration of the study
Key exclusion criteria (11 listed)
- Kurtzke Expanded Disability Status Scale (EDSS) score greater than 6.0
- Cognitive dysfunction that, in the Investigator's judgment, raises doubts about the study participant's ability to provide informed consent or accurately complete the monthly patient questionnaire
- Any use of Betaseron within the three months prior to study entry
- Inability to read, write, or speak the English language
- Illness or disease other than multiple sclerosis that the Investigator believes is likely to cause the patient's death or incapacity within twelve months
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 |
|---|---|---|
| BAY86-5046_Interferon-beta-1bElectronic questionnaires | Drug | Group 1 |
Primary outcome
Key Objective: To collect patient reported outcomes and clinical assessments via the same web-based data capture tool in a real world setting in relapse-remitting multiple sclerosis patients
Time frame: Baseline, 1 to12 month outcome questionnaires
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 Jul 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.
Bayer Study Director study director
Bayer
27 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, Relapsing-Remitting, run by Bayer at 27 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 8 inclusion and 11 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 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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?
Key Objective: To collect patient reported outcomes and clinical assessments via the same web-based data capture tool in a real world setting in relapse-remitting multiple sclerosis patients (time frame: Baseline, 1 to12 month outcome questionnaires). 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 Jul 2010.