BETAEVAL Global - The New BETACONNECT Auto-injector : Adherence and EVALuation of Multiple Sclerosis Patients Treated With Betaferon

November 5, 2017 updated by: Bayer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

498

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

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.

The study will be conducted in neurological centers and neurology departments specialized in the treatment of Multiple Sclerosis patients.

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 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.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Interferon beta-1b (Betaferon®, BAY 86-5046)
Patients will be treated with Betaferon
Device: BETACONNECT
Auto-injector device to support the injection of Betaferon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adherence to therapy at the final visit.
Time Frame: Up to 24 weeks
Up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction with and evaluation of the BETACONNECT auto-injector
Time Frame: At baseline,4 weeks,12 weeks and 24 weeks
Satisfaction with and evaluation of the BETACONNECT auto-injector will be recorded with the patient questionnaire
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
Injection site pain and prophylactic analgesic use will be recorded with the patient questionnaire
At baseline,4 weeks,12 weeks and 24 weeks
Health related quality of life
Time Frame: At baseline,12 weeks and 24 weeks
Health related quality of life will be measured with the self-administered Functional Assessment of Multiple Sclerosis (FAMS) questionnaire.
At baseline,12 weeks and 24 weeks
Anxiety
Time Frame: At baseline,12 weeks and 24 weeks
Anxiety will be measured with the self-administered Hospital anxiety and depression scale (HADS).
At baseline,12 weeks and 24 weeks
Depression
Time Frame: At baseline,12 weeks and 24 weeks
Depression will be measured with the self-administered Center for Epidemiologic Studies Depression Scale (CES-D).
At baseline,12 weeks and 24 weeks
Fatigue
Time Frame: At baseline,12 weeks and 24 weeks
Fatigue will be measured with the self-administered Fatigue Scale for Motor and Cognitive functions (FSMC).
At baseline,12 weeks and 24 weeks
Cognition
Time Frame: At baseline,12 weeks and 24 weeks
Cognition will be measured by the HCP with the Symbol Digit Modalities Test (SDMT).
At baseline,12 weeks and 24 weeks
Local skin reactions
Time Frame: At baseline,4 weeks,12 weeks and 24 weeks
Local skin reactions will be recorded by HCP evaluation (local inspection).
At baseline,4 weeks,12 weeks and 24 weeks
Injection-related specifics
Time Frame: At 4 weeks,12 weeks and 24 weeks
Injection-related specifics such as injection date, time, and speed will be recorded by the BETACONNECT device
At 4 weeks,12 weeks and 24 weeks

Collaborators and Investigators

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

Sponsor

Bayer

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)

October 20, 2014

Primary Completion (Actual)

July 19, 2016

Study Completion (Actual)

November 8, 2016

Study Registration Dates

First Submitted

September 19, 2014

First Submitted That Met QC Criteria

September 19, 2014

First Posted (Estimate)

September 25, 2014

Study Record Updates

Last Update Posted (Actual)

November 7, 2017

Last Update Submitted That Met QC Criteria

November 5, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17591
  • BF1401 (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.

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