Relapsing Remitting Multiple Sclerosis (RRMS)BEACONNCT00787657
Observational Study to Analyse the Impact of Nurse Support and Disease Related Factors on Long- Term Adherence to Betaferon Treatment
An observational study of Relapsing Remitting Multiple Sclerosis (RRMS), run by Bayer at 36 sites in 36 countries.
Trial summary
The Study analyses the influence of selected factors on adherence to Betaferon treatment in patients with early multiple sclerosis (MS). The Investigator will document the relevant medical data regarding multiple sclerosis at every hospital visit, the patient will fill in two questionnaires at every visit: one about… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis (RRMS)
- What is being tested?
- Interferon beta-1b (Betaseron, BAY86-5046)
- How many people
- 1,723 participants
- Where
- 36 sitesin 36 countries
- Study dates
- Jun 2008to Oct 2014
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients after clinical events suggestive of MS according to SMPC) and patients with elapsing / Remitting Multiple Sclerosis (RRMS) within the first two years of diagnosis
Who may be able to join
- Patients after first clinical event suggestive of multiple Sclerosis (MS) (according to SmPC) and patients with Relapsing / Remitting Multiple Sclerosis (RRMS) within the first two years of diagnosis.
Who cannot join
- Contra-indications as indicated in Betaferon summary of Products Characteristics (SmPC)
Trial locations and contacts
36 sites in 36 countries.
36 sites in 36 countries
Libya1 site
Study site
Many Locations
About this study
Official title: Betaferon Prospective Study on Adherence, Coping and Nursing Support
- The Study analyses the influence of selected factors on adherence to Betaferon treatment in patients with early multiple sclerosis (MS). The Investigator will document the relevant medical data regarding multiple sclerosis at every hospital visit, the patient will fill in two questionnaires at every visit: one about coping with the disease and the other about anxiety and depression.
- The Study particularly looks at the role of the support of the patient given by the multiple sclerosis nurses.The nurse will provide additional standardised information at start of treatment and will regularly phone the patient to ask standardised questions about the general condition with regard to the treatment, the disease and social support. At the end of the Study it will be assessed if the supportive measures and the standards in terms of adherence management in the hospital have some influence to increase long-term treatment adherence.
- Being tested
- Interferon beta-1b (Betaseron, BAY86-5046)
- Keywords
- Clinically Isolated Syndrome (CIS)
- 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.
Interferon beta-1b (Betaseron, BAY86-5046)Drug
Patients after first clinical events suggestive of MS (according to SMPC) and patients with RRMS within the first two years of diagnosis
| Study group | Role | What they receive |
|---|---|---|
| Arm 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.
Proportion of patients adhering to treatment
Measured: 6, 12, 18 and 24 months
Secondary outcomes (8)
Rate of early treatment termination
Measured: 6, 12, 18 and 24 months
Rate of study dropout
Measured: 6, 12, 18 and 24 months
Predictive value of BL parameters, WCQ, HADS, RODQ
Measured: 12 and 24 months
WCQ (Ways of Coping Questionnaire)
Measured: 6, 12, 18 and 24 months
HADS (Hospital Anxiety and Depression Scale)
Measured: 6, 12, 18 and 24 months
RODQ (Risk of Dropout Questionnaire)
Measured: Monthly over 6 months; every other month thereafter
EDSS (Expanded Disability Status Scale)
Measured: 6, 12, 18 and 24 months
Relapse rate
Measured: 6, 12, 18 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2008 (estimated)
- Study startJun 2008
- Primary completionSep 2013
- Study completionOct 2014
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 Relapsing Remitting Multiple Sclerosis (RRMS)Studies 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
- 1,723 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
- NCT00787657
- Sponsor's protocol ID
- 13852
- Other IDs
- 311941, BF0703
- Acronym
- BEACON
- Status last verified
- Oct 2015
- First submitted
- 6 Nov 2008
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Patti F, Penaherrera JN, Zieger L, Wicklein EM. Clinical characteristics of middle-aged and older patients with MS treated with interferon beta-1b: post-hoc analysis of a 2-year, prospective, international, observational study. BMC Neurol. 2021 Aug 23;21(1):324. doi: 10.1186/s12883-021-02347-w.
PubMed 34425763
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Betaferon Prospective Study on Adherence, Coping and Nursing Support
- ClinicalTrials.gov ID
- NCT00787657
- Acronym / sponsor ID
- BEACON / 13852
- Keywords
- Clinically Isolated Syndrome (CIS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,723 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 7 Nov 2008 (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 Study analyses the influence of selected factors on adherence to Betaferon treatment in patients with early multiple sclerosis (MS). The Investigator will document the relevant medical data regarding multiple sclerosis at every hospital visit, the patient will fill in two questionnaires at every visit: one about coping with the disease and the other about anxiety and depression.
- The Study particularly looks at the role of the support of the patient given by the multiple sclerosis nurses.The nurse will provide additional standardised information at start of treatment and will regularly phone the patient to ask standardised questions about the general condition with regard to the treatment, the disease and social support. At the end of the Study it will be assessed if the supportive measures and the standards in terms of adherence management in the hospital have some influence to increase long-term treatment adherence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | Drug: Interferon beta-1b (Betaseron, BAY86-5046) |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients after clinical events suggestive of MS according to SMPC) and patients with elapsing / Remitting Multiple Sclerosis (RRMS) within the first two years of diagnosis
Key inclusion criteria (1 listed)
- Patients after first clinical event suggestive of multiple Sclerosis (MS) (according to SmPC) and patients with Relapsing / Remitting Multiple Sclerosis (RRMS) within the first two years of diagnosis.
Key exclusion criteria (1 listed)
- Contra-indications as indicated in Betaferon summary of Products Characteristics (SmPC)
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)Patients after first clinical events suggestive of MS (according to SMPC) and patients with RRMS within the first two years of diagnosis | Drug | Arm 1 |
Primary outcome
Proportion of patients adhering to treatment
Time frame: 6, 12, 18 and 24 months
8 secondary outcomes
Rate of early treatment termination
Time frame: 6, 12, 18 and 24 months
Rate of study dropout
Time frame: 6, 12, 18 and 24 months
Predictive value of BL parameters, WCQ, HADS, RODQ
Time frame: 12 and 24 months
WCQ (Ways of Coping Questionnaire)
Time frame: 6, 12, 18 and 24 months
HADS (Hospital Anxiety and Depression Scale)
Time frame: 6, 12, 18 and 24 months
RODQ (Risk of Dropout Questionnaire)
Time frame: Monthly over 6 months; every other month thereafter
EDSS (Expanded Disability Status Scale)
Time frame: 6, 12, 18 and 24 months
Relapse rate
Time frame: 6, 12, 18 and 24 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 16 Oct 2015.
- Derived from this study: PubMed 34425763Patti F, Penaherrera JN, Zieger L, Wicklein EM. Clinical characteristics of middle-aged and older patients with MS treated with interferon beta-1b: post-hoc analysis of a 2-year, prospective, international, observational study. BMC Neurol. 2021 Aug 23;21(1):324. doi: 10.1186/s12883-021-02347-w.
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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
36 sites in 36 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing Remitting Multiple Sclerosis (RRMS), run by Bayer at 36 sites in 36 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 16 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Argentina, Bahrain, Belgium, Bosnia and Herzegovina, Canada and 31 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?
Proportion of patients adhering to treatment (time frame: 6, 12, 18 and 24 months). 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 NCT00787657, 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 16 Oct 2015.