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

Multiple Sclerosis Clinical Trial

— BETAPREDICT  

Official title:

BETAPREDICT - MS Patients Treated With BETAferon®: PREDICTors of Treatment Adherence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02486640
• Other study ID #: 18016
• Secondary ID: BF1502
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

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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