Multiple SclerosisFADONCT01354665
Depression and Fatigue in MS Patients Treated With Betaferon.
An observational study of Multiple Sclerosis, run by Bayer at 1 site in Poland.
Trial summary
This study aims to evaluate the occurence and severity of fatigue and depression in multiple sclerosis patients and the impact of Betaferon treatment on symptoms alterations. The study is conducted in routine practice setting hence no interference with standard care takes place. 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?
- Interferon beta-1b (Betaferon, BAY86-5046)
- Type of treatment
- Injection or infusion
- How many people
- 567 participants
- Where
- 1 sitePoland
- Study dates
- May 2010to Jun 2013
- 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: Adult patients with relapsing form of multiple sclerosis treated with Betaferon under routine practice setting.
Who may be able to join
- Relapsing-remitting multiple sclerosis
- Age 18+
- Patients initiating Betaferon treatment
Who cannot join
- Patients previously treated with any immunomodulatory drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Short-term Effect of Immunomodulatory Treatment With Interferon Beta-1b (Betaferon) on Fatigue and Depression in First-time Treated Patients With Relapsing-remitting Multiple Sclerosis.
This study aims to evaluate the occurence and severity of fatigue and depression in multiple sclerosis patients and the impact of Betaferon treatment on symptoms alterations.
The study is conducted in routine practice setting hence no interference with standard care takes place.
Pharmacologic treatments of MS-fatigue and depression will also be recorded.
- Conditions
- Multiple Sclerosis
- Being tested
- Interferon beta-1b (Betaferon, BAY86-5046)
- Keywords
- Multiple sclerosis, Interferon beta-1b, Fatigue, Depression
- Medical subject headings
- Multiple Sclerosis, Fatigue, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon beta-1b (Betaferon, BAY86-5046)Biological
Patients treated with regular dose of Betaferon injections (250 micrograms subcutaneously every other day) under routine practice setting.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Biological: Interferon beta-1b (Betaferon, BAY86-5046) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of fatigue score over time
Measured: short-term, mid-term and long-term changes will be assessed: 3 months vs. baseline, 6 months vs. baseline and 12 months vs. baseline
Secondary outcomes (4)
Changes of depression score over time
Measured: short-term, mid-term and long-term changes will be assessed: 3 months vs. baseline, 6 months vs. baseline and 12 months vs. baseline
Treatment adherence
Measured: 12 months
Clinical course of the disease
Measured: 12 months
Overall treatment tolerability as measured by rate of adverse events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2011 (estimated)
- Study startMay 2010
- Primary completionJun 2013
- Study completionJun 2013
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
- Prospective
- Enrolment
- 567 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354665
- Sponsor's protocol ID
- 15307
- Other IDs
- BF1012PL
- Acronym
- FADO
- Status last verified
- Jan 2015
- First submitted
- 16 May 2011
- Last updated
- 21 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Short-term Effect of Immunomodulatory Treatment With Interferon Beta-1b (Betaferon) on Fatigue and Depression in First-time Treated Patients With Relapsing-remitting Multiple Sclerosis.
- ClinicalTrials.gov ID
- NCT01354665
- Acronym / sponsor ID
- FADO / 15307
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Interferon beta-1b, Fatigue, Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 567 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 17 May 2011 (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 aims to evaluate the occurence and severity of fatigue and depression in multiple sclerosis patients and the impact of Betaferon treatment on symptoms alterations.
The study is conducted in routine practice setting hence no interference with standard care takes place.
Pharmacologic treatments of MS-fatigue and depression will also be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Biological: Interferon beta-1b (Betaferon, BAY86-5046) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with relapsing form of multiple sclerosis treated with Betaferon under routine practice setting.
Key inclusion criteria (3 listed)
- Relapsing-remitting multiple sclerosis
- Age 18+
- Patients initiating Betaferon treatment
Key exclusion criteria (1 listed)
- Patients previously treated with any immunomodulatory drug
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 (Betaferon, BAY86-5046)Patients treated with regular dose of Betaferon injections (250 micrograms subcutaneously every other day) under routine practice setting. | Biological | Group 1 |
Primary outcome
Changes of fatigue score over time
Time frame: short-term, mid-term and long-term changes will be assessed: 3 months vs. baseline, 6 months vs. baseline and 12 months vs. baseline
4 secondary outcomes
Changes of depression score over time
Time frame: short-term, mid-term and long-term changes will be assessed: 3 months vs. baseline, 6 months vs. baseline and 12 months vs. baseline
Treatment adherence
Time frame: 12 months
Clinical course of the disease
Time frame: 12 months
Overall treatment tolerability as measured by rate of adverse events
Time frame: 12 months
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 21 Jan 2015.
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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
1 site 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 Bayer at 1 site in Poland.
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 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 21 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
Changes of fatigue score over time (time frame: short-term, mid-term and long-term changes will be assessed: 3 months vs. baseline, 6 months vs. baseline and 12 months vs. baseline). 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 21 Jan 2015.