Multiple SclerosisBETAEVALNCT02121444
BAY86-5046 (Betaseron), Non Interventional Studies
An observational study of Multiple Sclerosis, run by Bayer at 1 site in Germany.
Trial summary
This study aims to investigate adherence to therapy among patients treated with Betaferon who are using the BETACONNECT autoinjector. 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, BAY 86-5046) and BETACONNECT auto-injector.
- Type of treatment
- Medical device
- How many people
- 151 participants
- Where
- 1 siteGermany
- Study dates
- 23 Jun 2014to 1 Jun 2016
- 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 with the diagnosis of relapsing remitting multiple sclerosis or a clinically isolated syndrome.
- Patients must be on treatment with Betaferon or the decision to treat patients with Betaferon has been made by the attending physician.
- Patient and attending physicians must have agreed on the usage of the BETACONNECT auto-injector device
- Written informed consent must be obtained.
Who cannot join
- Patients receiving any other disease modifying drug.
- Contraindications of Betaferon described in the Summary of Product Characteristics.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BETAEVAL - The New BETACONNECT® Auto-injector: Adherence and EVALuation of MS Patients Treated With Betaferon®
This study aims to investigate adherence to therapy among patients treated with Betaferon who are using the BETACONNECT autoinjector.
- Conditions
- Multiple Sclerosis
- Being tested
- Interferon beta-1b (Betaferon, BAY 86-5046), BETACONNECT auto-injector.
- Keywords
- RRMS, CIS
- 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 (Betaferon, BAY 86-5046)Drug
BETACONNECT auto-injector.Device
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Multiple Sclerosis patients who are treated with Betaferon and who are using the Betaconnect auto-injector Receives: Drug: Interferon beta-1b (Betaferon, BAY 86-5046); Device: BETACONNECT auto-injector. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence measure to Betaferon therapy based on the real BETACONNECT injections
Adherence to therapy will be defined as applying ≥80% of prescribed Betaferon dosages, which can be derived from electronic data stored in the BETACONNECT device.
Measured: up to 24 weeks
Secondary outcomes (9)
Satisfaction with and evaluation of the BETACONNECT auto-injector recorded by patient questionnaire
Measured: up to 24 weeks
Evaluation of health related quality of life,measured with the self-administered Functional Assessment of Multiple Sclerosis (FAMS) questionnaire
Measured: up to 24 weeks
Evaluation of Anxiety measured with the self-administered Hospital Anxiety and Depression Scale (HADS)
Measured: up to 24 weeks
Evaluation of Depression measured with the self-administered Center for Epidemiologic Studies Depression Scale (CES-D)
Measured: up to 24 weeks
Evaluation of Fatigue measured with the self-administered Fatigue Scale for Motor and Cognitive functions (FSMC)
Measured: up to 24 weeks
Evaluation of Cognition will be measured by the HCP with the Symbol Digit Modalities Test (SDMT)
Measured: up to 24 weeks
Local skin reactions recorded by Health Care Provider (HCP) evaluation
Measured: up to 24 weeks
Evaluation of injection-related specifics such as injection date, time, and speed will be recorded by the BETACONNECT device
Measured: up to 24 weeks
Number of Treatment-emergent Adverse Events (TEAE)
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study start23 Jun 2014
- Primary completion9 Mar 2016
- Study completion1 Jun 2016
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
- 151 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
- NCT02121444
- Sponsor's protocol ID
- 17101
- Other IDs
- BF1414DE
- Acronym
- BETAEVAL
- Status last verified
- Oct 2017
- First submitted
- 22 Apr 2014
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Kleiter I, Lang M, Jeske J, Norenberg C, Stollfuss B, Schurks M. Adherence, satisfaction and functional health status among patients with multiple sclerosis using the BETACONNECT(R) autoinjector: a prospective observational cohort study. BMC Neurol. 2017 Sep 6;17(1):174. doi: 10.1186/s12883-017-0953-8.
PubMed 28877664
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BETAEVAL - The New BETACONNECT® Auto-injector: Adherence and EVALuation of MS Patients Treated With Betaferon®
- ClinicalTrials.gov ID
- NCT02121444
- Acronym / sponsor ID
- BETAEVAL / 17101
- Conditions
- Multiple Sclerosis
- Keywords
- RRMS, CIS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2014 (actual)
- Primary completion
- 9 Mar 2016 (actual)
- Study completion
- 1 Jun 2016 (actual)
- First posted
- 23 Apr 2014 (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 investigate adherence to therapy among patients treated with Betaferon who are using the BETACONNECT autoinjector.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: Interferon beta-1b (Betaferon, BAY 86-5046), Device: BETACONNECT auto-injector.Multiple Sclerosis patients who are treated with Betaferon and who are using the Betaconnect auto-injector |
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 with the diagnosis of relapsing remitting multiple sclerosis or a clinically isolated syndrome.
- Patients must be on treatment with Betaferon or the decision to treat patients with Betaferon has been made by the attending physician.
- Patient and attending physicians must have agreed on the usage of the BETACONNECT auto-injector device
- Written informed consent must be obtained.
Key exclusion criteria (2 listed)
- Patients receiving any other disease modifying drug.
- Contraindications of Betaferon described in the Summary of Product Characteristics.
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, BAY 86-5046) | Drug | Cohort 1 |
| BETACONNECT auto-injector. | Device | Cohort 1 |
Primary outcome
Adherence measure to Betaferon therapy based on the real BETACONNECT injections
Time frame: up to 24 weeks
Adherence to therapy will be defined as applying ≥80% of prescribed Betaferon dosages, which can be derived from electronic data stored in the BETACONNECT device.
9 secondary outcomes
Satisfaction with and evaluation of the BETACONNECT auto-injector recorded by patient questionnaire
Time frame: up to 24 weeks
Evaluation of health related quality of life,measured with the self-administered Functional Assessment of Multiple Sclerosis (FAMS) questionnaire
Time frame: up to 24 weeks
Evaluation of Anxiety measured with the self-administered Hospital Anxiety and Depression Scale (HADS)
Time frame: up to 24 weeks
Evaluation of Depression measured with the self-administered Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: up to 24 weeks
Evaluation of Fatigue measured with the self-administered Fatigue Scale for Motor and Cognitive functions (FSMC)
Time frame: up to 24 weeks
Evaluation of Cognition will be measured by the HCP with the Symbol Digit Modalities Test (SDMT)
Time frame: up to 24 weeks
Local skin reactions recorded by Health Care Provider (HCP) evaluation
Time frame: up to 24 weeks
Evaluation of injection-related specifics such as injection date, time, and speed will be recorded by the BETACONNECT device
Time frame: up to 24 weeks
Number of Treatment-emergent Adverse Events (TEAE)
Time frame: up to 24 weeks
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 18 Oct 2017.
- Derived from this study: PubMed 28877664Kleiter I, Lang M, Jeske J, Norenberg C, Stollfuss B, Schurks M. Adherence, satisfaction and functional health status among patients with multiple sclerosis using the BETACONNECT(R) autoinjector: a prospective observational cohort study. BMC Neurol. 2017 Sep 6;17(1):174. doi: 10.1186/s12883-017-0953-8.
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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 2 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 18 Oct 2017. 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?
Adherence measure to Betaferon therapy based on the real BETACONNECT injections (time frame: up to 24 weeks). 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 NCT02121444, 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 18 Oct 2017.