Multiple Sclerosis, Relapsing RemittingNCT02247310
BETAEVAL Global - The New BETACONNECT Auto-injector : Adherence and EVALuation of Multiple Sclerosis Patients Treated With Betaferon
An observational study of Multiple Sclerosis, Relapsing Remitting, run by Bayer at 11 sites in 11 countries.
Trial summary
Considering the significance of an early and consequent Multiple Sclerosis (MS) treatment as well as the challenge to achieve high adherence to treatment, evaluating the benefits of any new measure to improve adherence is important. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis, Relapsing Remitting
- What is being tested?
- Interferon beta-1b (Betaferon®, BAY 86-5046) and BETACONNECT
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 498 participants
- Where
- 11 sitesin 11 countries
- Study dates
- 20 Oct 2014to 8 Nov 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 Any age
- All sexes
- No healthy volunteers
- Child, 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. The study will be conducted in neurological centers and neurology departments specialized in the treatment of Multiple Sclerosis patients.
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 a patient 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
11 sites in 11 countries.
11 sites in 11 countries
About this study
Official title: BETAEVAL_Global- The New BETACONNECT® Auto-injector: Adherence and EVALuation of MS Patients Treated With Betaferon®
Considering the significance of an early and consequent Multiple Sclerosis (MS) treatment as well as the challenge to achieve high adherence to treatment, evaluating the benefits of any new measure to improve adherence is important. The data storage capabilities of the BETACONNECT device, including the automated recording of injections, will facilitate the collection of reliable data on patient's injection behavior and adherence, which should be unaffected by recall bias or reporting bias.
To better understand the utilities of the new BETACONNECT device and characterize its contribution to adherence, we plan to prospectively follow-up MS patients using this device for 24 weeks. The study will take place in a real-life setting in Neurology centers across Europe.
- Conditions
- Multiple Sclerosis, Relapsing Remitting
- Being tested
- Interferon beta-1b (Betaferon®, BAY 86-5046), BETACONNECT
- 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 (Betaferon®, BAY 86-5046)Drug
Patients will be treated with Betaferon
BETACONNECTDevice
Auto-injector device to support the injection of Betaferon
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Patients with the diagnosis of relapsing remitting multiple sclerosis or a clinically isolated syndrome and be on treatment with Betaferon using the BETACONNECT auto-injector device. Receives: Drug: Interferon beta-1b (Betaferon®, BAY 86-5046); Device: BETACONNECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to therapy at the final visit.
Measured: Up to 24 weeks
Secondary outcomes (9)
Satisfaction with and evaluation of the BETACONNECT auto-injector
Satisfaction with and evaluation of the BETACONNECT auto-injector will be recorded with the patient questionnaire
Measured: At baseline,4 weeks,12 weeks and 24 weeks
Injection site pain and prophylactic analgesic use
Injection site pain and prophylactic analgesic use will be recorded with the patient questionnaire
Measured: At baseline,4 weeks,12 weeks and 24 weeks
Health related quality of life
Health related quality of life will be measured with the self-administered Functional Assessment of Multiple Sclerosis (FAMS) questionnaire.
Measured: At baseline,12 weeks and 24 weeks
Anxiety
Anxiety will be measured with the self-administered Hospital anxiety and depression scale (HADS).
Measured: At baseline,12 weeks and 24 weeks
Depression
Depression will be measured with the self-administered Center for Epidemiologic Studies Depression Scale (CES-D).
Measured: At baseline,12 weeks and 24 weeks
Fatigue
Fatigue will be measured with the self-administered Fatigue Scale for Motor and Cognitive functions (FSMC).
Measured: At baseline,12 weeks and 24 weeks
Cognition
Cognition will be measured by the HCP with the Symbol Digit Modalities Test (SDMT).
Measured: At baseline,12 weeks and 24 weeks
Local skin reactions
Local skin reactions will be recorded by HCP evaluation (local inspection).
Measured: At baseline,4 weeks,12 weeks and 24 weeks
Injection-related specifics
Injection-related specifics such as injection date, time, and speed will be recorded by the BETACONNECT device
Measured: At 4 weeks,12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study start20 Oct 2014
- Primary completion19 Jul 2016
- Study completion8 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing RemittingStudies 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
- 498 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
- NCT02247310
- Sponsor's protocol ID
- 17591
- Other IDs
- BF1401
- Status last verified
- Nov 2017
- First submitted
- 19 Sep 2014
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BETAEVAL_Global- The New BETACONNECT® Auto-injector: Adherence and EVALuation of MS Patients Treated With Betaferon®
- ClinicalTrials.gov ID
- NCT02247310
- Acronym / sponsor ID
- 17591
- Conditions
- Multiple Sclerosis, Relapsing Remitting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 498 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2014 (actual)
- Primary completion
- 19 Jul 2016 (actual)
- Study completion
- 8 Nov 2016 (actual)
- First posted
- 25 Sep 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.
Considering the significance of an early and consequent Multiple Sclerosis (MS) treatment as well as the challenge to achieve high adherence to treatment, evaluating the benefits of any new measure to improve adherence is important. The data storage capabilities of the BETACONNECT device, including the automated recording of injections, will facilitate the collection of reliable data on patient's injection behavior and adherence, which should be unaffected by recall bias or reporting bias.
To better understand the utilities of the new BETACONNECT device and characterize its contribution to adherence, we plan to prospectively follow-up MS patients using this device for 24 weeks. The study will take place in a real-life setting in Neurology centers across Europe.
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: BETACONNECTPatients with the diagnosis of relapsing remitting multiple sclerosis or a clinically isolated syndrome and be on treatment with Betaferon using the BETACONNECT auto-injector device. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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. The study will be conducted in neurological centers and neurology departments specialized in the treatment of Multiple Sclerosis patients.
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 a patient 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)Patients will be treated with Betaferon | Drug | Cohort 1 |
| BETACONNECTAuto-injector device to support the injection of Betaferon | Device | Cohort 1 |
Primary outcome
Adherence to therapy at the final visit.
Time frame: Up to 24 weeks
9 secondary outcomes
Satisfaction with and evaluation of the BETACONNECT auto-injector
Time frame: At baseline,4 weeks,12 weeks and 24 weeks
Injection site pain and prophylactic analgesic use
Time frame: At baseline,4 weeks,12 weeks and 24 weeks
Health related quality of life
Time frame: At baseline,12 weeks and 24 weeks
Anxiety
Time frame: At baseline,12 weeks and 24 weeks
Depression
Time frame: At baseline,12 weeks and 24 weeks
Fatigue
Time frame: At baseline,12 weeks and 24 weeks
Cognition
Time frame: At baseline,12 weeks and 24 weeks
Local skin reactions
Time frame: At baseline,4 weeks,12 weeks and 24 weeks
Injection-related specifics
Time frame: At 4 weeks,12 weeks and 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 7 Nov 2017.
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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
11 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, Relapsing Remitting, run by Bayer at 11 sites in 11 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 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 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Austria, Belgium, Bosnia and Herzegovina, Croatia, Czechia and 6 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?
Adherence to therapy at the final visit. (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?
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 7 Nov 2017.