BAY86-5046 (Betaseron), Non Interventional Studies (BETAEVAL)

October 16, 2017 updated by: Bayer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

151

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

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

Genders Eligible for Study

All

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 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.

Exclusion Criteria:

  • Patients receiving any other disease modifying drug.
  • Contraindications of Betaferon described in the Summary of Product Characteristics.

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
Cohort 1
Multiple Sclerosis patients who are treated with Betaferon and who are using the Betaconnect auto-injector
Drug: Interferon beta-1b (Betaferon, BAY 86-5046)
Device: BETACONNECT auto-injector.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Satisfaction with and evaluation of the BETACONNECT auto-injector recorded by patient questionnaire
Time Frame: up to 24 weeks
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
up to 24 weeks
Evaluation of Anxiety measured with the self-administered Hospital Anxiety and Depression Scale (HADS)
Time Frame: up to 24 weeks
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
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
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
up to 24 weeks
Local skin reactions recorded by Health Care Provider (HCP) evaluation
Time Frame: up to 24 weeks
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
up to 24 weeks
Number of Treatment-emergent Adverse Events (TEAE)
Time Frame: up to 24 weeks
up to 24 weeks

Collaborators and Investigators

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

Sponsor

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

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)

June 23, 2014

Primary Completion (Actual)

March 9, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

April 22, 2014

First Submitted That Met QC Criteria

April 22, 2014

First Posted (Estimate)

April 23, 2014

Study Record Updates

Last Update Posted (Actual)

October 18, 2017

Last Update Submitted That Met QC Criteria

October 16, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17101
  • BF1414DE (Other Identifier: Company internal)

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.

Clinical Trials on Multiple Sclerosis

Clinical Trials on Interferon beta-1b (Betaferon, BAY 86-5046)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe