Multiple SclerosisNCT00544037
BENEFIT Extension Study
An observational study of Multiple Sclerosis, run by Bayer at 18 sites in 18 countries.
Trial summary
To assess the long-term effects of early therapeutic intervention, i.e. within two years following a first clinical demyelinating event suggestive of MS. Read more about this study
- Who is it for?
- Ages 23 to 50 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Interferon beta-1b (Betaseron, BAY86-5046)
- How many people
- 283 participants
- Where
- 18 sitesin 18 countries
- Study dates
- Sep 2007to Jan 2011
- 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 23 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: This observational study may include all patients who were randomized into and treated at least once in the BENEFIT study 304747, inclusive of patients who prematurely discontinued study participation in either study 304747 or study 305207, and patients who did not transfer from study 304747 to study 305207.
Who may be able to join
- All patients randomized and treated at least once in study 304747
Who cannot join
- Medical, psychiatric or other conditions that compromise the patient's ability to understand the purpose of the study
Trial locations and contacts
18 sites in 18 countries.
18 sites in 18 countries
About this study
Official title: Extension Study of the BENEFIT (304747) and BENEFIT Follow-up (305207) Studies to Further Evaluate the Progress of Patients With First Demyelinating Event Suggestive of Multiple Sclerosis
To assess the long-term effects of early therapeutic intervention, i.e. within two years following a first clinical demyelinating event suggestive of MS.
- Conditions
- Multiple Sclerosis
- Being tested
- Interferon beta-1b (Betaseron, 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.
Interferon beta-1b (Betaseron, BAY86-5046)Drug
Standard Therapy for Multiple Sclerosis
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Interferon beta-1b (Betaseron, BAY86-5046) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To obtain further clinical data of patients with a first demyelinating event suggestive of Multiple Sclerosis enrolled in the BENEFIT Study
Measured: End of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prospective
- Enrolment
- 283 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
- NCT00544037
- Sponsor's protocol ID
- 91713
- Other IDs
- 311129
- Status last verified
- Mar 2012
- First submitted
- 15 Oct 2007
- Last updated
- 5 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Nagtegaal GJ, Pohl C, Wattjes MP, Hulst HE, Freedman MS, Hartung HP, Miller D, Montalban X, Kappos L, Edan G, Pleimes D, Beckman K, Stemper B, Polman CH, Sandbrink R, Barkhof F. Interferon beta-1b reduces black holes in a randomised trial of clinically isolated syndrome. Mult Scler. 2014 Feb;20(2):234-42. doi: 10.1177/1352458513494491. Epub 2013 Jul 10.
PubMed 23842212
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extension Study of the BENEFIT (304747) and BENEFIT Follow-up (305207) Studies to Further Evaluate the Progress of Patients With First Demyelinating Event Suggestive of Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00544037
- Acronym / sponsor ID
- 91713
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 16 Oct 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.
To assess the long-term effects of early therapeutic intervention, i.e. within two years following a first clinical demyelinating event suggestive of MS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Interferon beta-1b (Betaseron, BAY86-5046) |
Who may qualify
- Ages
- 23 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This observational study may include all patients who were randomized into and treated at least once in the BENEFIT study 304747, inclusive of patients who prematurely discontinued study participation in either study 304747 or study 305207, and patients who did not transfer from study 304747 to study 305207.
Key inclusion criteria (1 listed)
- All patients randomized and treated at least once in study 304747
Key exclusion criteria (1 listed)
- Medical, psychiatric or other conditions that compromise the patient's ability to understand the purpose of the study
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-1b (Betaseron, BAY86-5046)Standard Therapy for Multiple Sclerosis | Drug | Group 1 |
Primary outcome
To obtain further clinical data of patients with a first demyelinating event suggestive of Multiple Sclerosis enrolled in the BENEFIT Study
Time frame: End of Study
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 Mar 2012.
- Derived from this study: PubMed 23842212Nagtegaal GJ, Pohl C, Wattjes MP, Hulst HE, Freedman MS, Hartung HP, Miller D, Montalban X, Kappos L, Edan G, Pleimes D, Beckman K, Stemper B, Polman CH, Sandbrink R, Barkhof F. Interferon beta-1b reduces black holes in a randomised trial of clinically isolated syndrome. Mult Scler. 2014 Feb;20(2):234-42. doi: 10.1177/1352458513494491. Epub 2013 Jul 10.
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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
18 sites in 18 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 18 sites in 18 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 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 5 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Austria, Belgium, Canada, Czechia, Denmark and 13 more countries. 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 obtain further clinical data of patients with a first demyelinating event suggestive of Multiple Sclerosis enrolled in the BENEFIT Study (time frame: End of Study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00544037, which also lists 1 linked publication.
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 Mar 2012.