BAY86-5046 (Betaseron), Non Interventional Studies

Bayer151 enrolled

Overview

This study aims to investigate adherence to therapy among patients treated with Betaferon who are using the BETACONNECT autoinjector.

Study Type

OBSERVATIONAL

Enrollment

151

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1b (Betaferon, BAY 86-5046)DRUG

BETACONNECT auto-injector.DEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Many Locations, Germany

Outcomes

Primary Outcomes

Adherence measure to Betaferon therapy based on the real BETACONNECT injections

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.

Time frame: up to 24 weeks

Secondary Outcomes

Satisfaction with and evaluation of the BETACONNECT auto-injector recorded by patient questionnaire

Time frame: 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

Evaluation of Anxiety measured with the self-administered Hospital Anxiety and Depression Scale (HADS)

Time frame: 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

Evaluation of Fatigue measured with the self-administered Fatigue Scale for Motor and Cognitive functions (FSMC)

Time frame: 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

Local skin reactions recorded by Health Care Provider (HCP) evaluation

Time frame: up to 24 weeks

Evaluation of injection-related specifics such as injection date, time, and speed will be recorded by the BETACONNECT device

Data from ClinicalTrials.gov

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