BAY86-5046 (Betaseron), Non Interventional Studies

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: Interferon beta-1b (Betaferon, BAY 86-5046); Device: BETACONNECT auto-injector.

• Registration Number: NCT02121444
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-22
• Study First Submitted QC: 2014-04-22
• Study First Posted: 2014-04-23
• Study Start: 2014-06-23
• Primary Completion: 2016-03-09
• Study Completion: 2016-06-01
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-16
• Last Update Posted: 2017-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

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.

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Exclusion Criteria

• Patients receiving any other disease modifying drug.
• Contraindications of Betaferon described in the Summary of Product Characteristics.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	BETACONNECT auto-injector.	Multiple Sclerosis patients who are treated with Betaferon and who are using the Betaconnect auto-injector
Cohort 1	Interferon beta-1b (Betaferon, BAY 86-5046)	Multiple Sclerosis patients who are treated with Betaferon and who are using the Betaconnect auto-injector

Primary Outcome Measures

Name	Time	Method
Adherence measure to Betaferon therapy based on the real BETACONNECT injections	up to 24 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Satisfaction with and evaluation of the BETACONNECT auto-injector recorded by patient questionnaire	up to 24 weeks
Evaluation of health related quality of life,measured with the self-administered Functional Assessment of Multiple Sclerosis (FAMS) questionnaire	up to 24 weeks
Evaluation of Cognition will be measured by the HCP with the Symbol Digit Modalities Test (SDMT)	up to 24 weeks
Local skin reactions recorded by Health Care Provider (HCP) evaluation	up to 24 weeks
Evaluation of Anxiety measured with the self-administered Hospital Anxiety and Depression Scale (HADS)	up to 24 weeks
Evaluation of Depression measured with the self-administered Center for Epidemiologic Studies Depression Scale (CES-D)	up to 24 weeks
Evaluation of Fatigue measured with the self-administered Fatigue Scale for Motor and Cognitive functions (FSMC)	up to 24 weeks
Evaluation of injection-related specifics such as injection date, time, and speed will be recorded by the BETACONNECT device	up to 24 weeks
Number of Treatment-emergent Adverse Events (TEAE)	up to 24 weeks