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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02486640
Other study ID # 18016
Secondary ID BF1502
Status Completed
Phase
First received
Last updated
Start date September 8, 2015
Est. completion date January 16, 2020

Study information

Verified date July 2023
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to evaluate potential predictors of adherence by investigating a representative cohort of MS patients in Germany treated with Betaferon


Recruitment information / eligibility

Status Completed
Enrollment 162
Est. completion date January 16, 2020
Est. primary completion date October 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Compliance to therapy (%) 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
Primary Persistence of therapy (Yes or No) Persistence is defined as patients continuing ("persisting") their medication (regardless of the frequency of intake) 12 months
Primary Overall adherence to therapy (Yes or No) 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 Satisfaction with the BETACONNECT autoinjector, recorded by the patient questionnaire Up to 24 months
Secondary 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) Up to 24 months
Secondary Adherence to Betaferon treatment is associated with number of relapses (Yes or No) 12 months, 24 months
Secondary Adherence to Betaferon treatment is associated with EDSS change (Yes or No) EDSS (Expanded Disability Status Scale) 12 months, 24 months
Secondary Adherence to Betaferon treatment is associated with utilities of treatment, recorded by the EQ-5D quality of life questionnaire (Yes or No) Up to 24 months
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