Multiple SclerosisBETAPREDICTNCT02486640
Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
An observational study of Multiple Sclerosis, run by Bayer at 1 site in Germany.
Trial summary
This study aims to evaluate potential predictors of adherence by investigating a representative cohort of MS patients in Germany treated with Betaferon 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) and Betaconnect Autoinjector
- Type of treatment
- Medical device
- How many people
- 162 participants
- Where
- 1 siteGermany
- Study dates
- 8 Sep 2015to 16 Jan 2020
- 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: The study population will consist of patients with relapsing remitting multiple sclerosis (RRMS) or patients with a clinically isolated syndrome (CIS) who are treated with Betaferon or will be treated with Betaferon according to the attending physician's decision and for whom the patient and the physician have agreed to use the BETACONNECT device
Who may be able to join
- Patients aged ≥ 18 years with the diagnosis of relapsing remitting multiple sclerosis or a clinically isolated syndrome
- Patients on treatment with Betaferon or the decision to treat patients with Betaferon has been made by the attending physician
- Patients using or willing to use the BETACONNECT autoinjector for Betaferon application
- Written informed consent
Who cannot join
- Patients receiving any other disease modifying drug
- Contraindications of Betaferon described in the Summary of Product Characteristics
- Patients participating in any other clinical or non-interventional study, evaluating MS therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BETAPREDICT - MS Patients Treated With BETAferon®: PREDICTors of Treatment Adherence
This study aims to evaluate potential predictors of adherence by investigating a representative cohort of MS patients in Germany treated with Betaferon
- Conditions
- Multiple Sclerosis
- Being tested
- Interferon beta-1b (Betaferon, BAY86-5046), Betaconnect Autoinjector
- Keywords
- RRMS, CIS
- Medical subject headings
- Multiple Sclerosis, Carcinoma in Situ
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)Drug
Multiple Sclerosis patients who are treated with Betaferon and who are using the Betaconnect autoinjector.
Betaconnect AutoinjectorDevice
Multiple Sclerosis patients who are treated with Betaferon and who are using the Betaconnect autoinjector.
| Study group | Role | What they receive |
|---|---|---|
| Betaferon | Not described Receives: Drug: Interferon beta-1b (Betaferon, BAY86-5046); Device: Betaconnect Autoinjector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance to therapy (%)
Compliance (%) = ((expected # of treatment days during observation period - missed # of treatment days during observation period)/(expected # of treatment days during observation period))*100
Measured: 12 months
Persistence of therapy (Yes or No)
Persistence is defined as patients continuing ("persisting") their medication (regardless of the frequency of intake)
Measured: 12 months
Overall adherence to therapy (Yes or No)
Patients will be defined as being adherent to therapy if they fulfill the following criteria: a. They have been at least 80% compliant, i.e. injected ≥80% of the expected Betaferon dosages and b. They have not dropped out of the study prior to the time of evaluation (i.e. they did not stop Betaferon treatment for any reason including switching to another medication prior to the time of evaluation).
Measured: 12 months
Secondary outcomes (5)
Satisfaction with the BETACONNECT autoinjector, recorded by the patient questionnaire
Measured: Up to 24 months
Adherence to Betaferon treatment is associated with: depression, health related quality of life, coping mechanisms, self-management mechanisms, social support, fatigue, and cognition. (Yes or No)
Measured: Up to 24 months
Adherence to Betaferon treatment is associated with number of relapses (Yes or No)
Measured: 12 months, 24 months
Adherence to Betaferon treatment is associated with EDSS change (Yes or No)
EDSS (Expanded Disability Status Scale)
Measured: 12 months, 24 months
Adherence to Betaferon treatment is associated with utilities of treatment, recorded by the EQ-5D quality of life questionnaire (Yes or No)
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study start8 Sep 2015
- Primary completion31 Oct 2019
- Study completion16 Jan 2020
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
- 162 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
- NCT02486640
- Sponsor's protocol ID
- 18016
- Other IDs
- BF1502
- Acronym
- BETAPREDICT
- Status last verified
- Jul 2023
- First submitted
- 15 Jun 2015
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Kohler W, Bayer-Gersmann K, Neusser T, Schurks M, Ziemssen T. Predictors of Adherence Among Patients With Multiple Sclerosis Using the BETACONNECT(R) Autoinjector: A Prospective Observational Cohort Study. Front Neurol. 2021 Feb 24;12:643126. doi: 10.3389/fneur.2021.643126. eCollection 2021.
PubMed 33716945
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BETAPREDICT - MS Patients Treated With BETAferon®: PREDICTors of Treatment Adherence
- ClinicalTrials.gov ID
- NCT02486640
- Acronym / sponsor ID
- BETAPREDICT / 18016
- Conditions
- Multiple Sclerosis
- Keywords
- RRMS, CIS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2015 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 16 Jan 2020 (actual)
- First posted
- 1 Jul 2015 (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 potential predictors of adherence by investigating a representative cohort of MS patients in Germany treated with Betaferon
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Betaferon | – | Drug: Interferon beta-1b (Betaferon, BAY86-5046), Device: Betaconnect Autoinjector |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of patients with relapsing remitting multiple sclerosis (RRMS) or patients with a clinically isolated syndrome (CIS) who are treated with Betaferon or will be treated with Betaferon according to the attending physician's decision and for whom the patient and the physician have agreed to use the BETACONNECT device
Key inclusion criteria (4 listed)
- Patients aged ≥ 18 years with the diagnosis of relapsing remitting multiple sclerosis or a clinically isolated syndrome
- Patients on treatment with Betaferon or the decision to treat patients with Betaferon has been made by the attending physician
- Patients using or willing to use the BETACONNECT autoinjector for Betaferon application
- Written informed consent
Key exclusion criteria (3 listed)
- Patients receiving any other disease modifying drug
- Contraindications of Betaferon described in the Summary of Product Characteristics
- Patients participating in any other clinical or non-interventional study, evaluating MS therapy
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)Multiple Sclerosis patients who are treated with Betaferon and who are using the Betaconnect autoinjector. | Drug | Betaferon |
| Betaconnect AutoinjectorMultiple Sclerosis patients who are treated with Betaferon and who are using the Betaconnect autoinjector. | Device | Betaferon |
Primary outcome
Compliance to therapy (%)
Time frame: 12 months
Compliance (%) = ((expected # of treatment days during observation period - missed # of treatment days during observation period)/(expected # of treatment days during observation period))*100
Persistence of therapy (Yes or No)
Time frame: 12 months
Persistence is defined as patients continuing ("persisting") their medication (regardless of the frequency of intake)
Overall adherence to therapy (Yes or No)
Time frame: 12 months
Patients will be defined as being adherent to therapy if they fulfill the following criteria: a. They have been at least 80% compliant, i.e. injected ≥80% of the expected Betaferon dosages and b. They have not dropped out of the study prior to the time of evaluation (i.e. they did not stop Betaferon treatment for any reason including switching to another medication prior to the time of evaluation).
5 secondary outcomes
Satisfaction with the BETACONNECT autoinjector, recorded by the patient questionnaire
Time frame: Up to 24 months
Adherence to Betaferon treatment is associated with: depression, health related quality of life, coping mechanisms, self-management mechanisms, social support, fatigue, and cognition. (Yes or No)
Time frame: Up to 24 months
Adherence to Betaferon treatment is associated with number of relapses (Yes or No)
Time frame: 12 months, 24 months
Adherence to Betaferon treatment is associated with EDSS change (Yes or No)
Time frame: 12 months, 24 months
Adherence to Betaferon treatment is associated with utilities of treatment, recorded by the EQ-5D quality of life questionnaire (Yes or No)
Time frame: Up to 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 24 Jul 2023.
- Derived from this study: PubMed 33716945Kohler W, Bayer-Gersmann K, Neusser T, Schurks M, Ziemssen T. Predictors of Adherence Among Patients With Multiple Sclerosis Using the BETACONNECT(R) Autoinjector: A Prospective Observational Cohort Study. Front Neurol. 2021 Feb 24;12:643126. doi: 10.3389/fneur.2021.643126. eCollection 2021.
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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 Germany.
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 4 inclusion and 3 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 24 Jul 2023. 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 Germany. 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?
Compliance to therapy (%) (time frame: 12 months). The study lists 3 primary outcomes in all. 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 NCT02486640, 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 24 Jul 2023.