An observational study in Multiple Sclerosis, sponsored by Bayer. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-26.
Sponsored by Bayer · Observational
The planned study will be a prospective, non-interventional, observational cohort study using the structure of a registry. Medication usage behavior will be observed for 6 months, while documentation behavior on the wellness tracker in the myBETAapp will be observed for 3 months.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 96 is close to the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population will consist of patients with multiple sclerosis who are treated with Betaferon and who are using the myBETAapp.
Exclusion Criteria:
-There are no exclusion criteria for participation in this study.
Women and men in Germany with the diagnosis of MS that are treated with Betaferon and use the myBETAapp
Drug: Interferon beta-1b (Betaferon, BAY86-5046) · Device: Betaconnect auto-injector · Device: myBETAapp
Solution for injection
Auto-injector for application of Betaferon solution which automatically covers injection related data
Medical device which can be connected with Betaconnect auto-injector and displays injection related data to patients and offers tracking of patient reported data at the wellness- tracker
Compliance to therapy (%)
Compliance (%) = ((true # of treatment days as derived from the data stored in the BETACONNECT)/(expected # of treatment days during observation period based on the injection frequency stipulated by the label))x100
Time frame: 6 months
Persistence of therapy (yes, no)
Persistence will be evaluated from the day of the first injection recorded in the BETACONNECT until the day of the last recorded injection or the end of observation (whichever comes first)
Time frame: 6 months
Adherence to therapy (yes, no)
Patients will be defined as being adherent to therapy if they fulfill the following criteria: 1. They have been at least 80% compliant, i.e. applied ≥80% of the expected Betaferon injections and 2. They have not dropped out of the study prior to the time of evaluation (i.e. they did not (1) stop using the myBETAapp or (2) withdraw their consent to participate in the study)
Time frame: 6 months
Proportion of patients consenting to participate in this study among those using the myBETAapp
All patients registering their myBETAapp will be asked to participate in the study. Patients consenting to participate in the study will be flagged in the database. The proportion of patients consenting will then be calculated by dividing the number of patients giving consent by all patients asked.
Time frame: 3 months
Proportion of patients volunteering to record wellness related data in each of the following categories on the "Wellness chart" on the myBETAapp
Wellness Chart:(1) ability to walk, (2) coordination, (3) energy level, (4) bladder control, (5) exercise level,(6) memory, (7) vision, (8) bowel control, (9) emotions, and (10) eating habits
Time frame: 3 months
Plan to share: No
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bayer