Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon (BETAPREDICT)

July 20, 2023 updated by: Bayer

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

162

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Sachsen
      • Wermsdorf, Sachsen, Germany, 04779

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Betaferon
Drug: Interferon beta-1b (Betaferon, BAY86-5046)
Multiple Sclerosis patients who are treated with Betaferon and who are using the Betaconnect autoinjector.
Device: Betaconnect Autoinjector
Multiple Sclerosis patients who are treated with Betaferon and who are using the Betaconnect autoinjector.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months
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)
12 months
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).
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction with the BETACONNECT autoinjector, recorded by the patient questionnaire
Time Frame: Up to 24 months
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
Up to 24 months
Adherence to Betaferon treatment is associated with number of relapses (Yes or No)
Time Frame: 12 months, 24 months
12 months, 24 months
Adherence to Betaferon treatment is associated with EDSS change (Yes or No)
Time Frame: 12 months, 24 months
EDSS (Expanded Disability Status Scale)
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
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Investigators

  • Study Director: Bayer Study Director, Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2015

Primary Completion (Actual)

October 31, 2019

Study Completion (Actual)

January 16, 2020

Study Registration Dates

First Submitted

June 15, 2015

First Submitted That Met QC Criteria

June 29, 2015

First Posted (Estimated)

July 1, 2015

Study Record Updates

Last Update Posted (Estimated)

July 24, 2023

Last Update Submitted That Met QC Criteria

July 20, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18016
  • BF1502 (Registry Identifier: NIS Trial Alias)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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