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

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: Interferon beta-1b (Betaferon, BAY86-5046); Device: Betaconnect Autoinjector

• Registration Number: NCT02486640
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-15
• Study First Submitted QC: 2015-06-29
• Study First Posted: 2015-07-01
• Study Start: 2015-09-08
• Primary Completion: 2019-10-31
• Study Completion: 2020-01-16
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-20
• Last Update Posted: 2023-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Betaferon	Interferon beta-1b (Betaferon, BAY86-5046)	-
Betaferon	Betaconnect Autoinjector	-

Primary Outcome Measures

Name	Time	Method
Compliance to therapy (%)	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
Persistence of therapy (Yes or No)	12 months	Persistence is defined as patients continuing ("persisting") their medication (regardless of the frequency of intake)
Overall adherence to therapy (Yes or No)	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).

Secondary Outcome Measures

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