Study of Betaferon Adherence in Patients With Multiple Sclerosis Treated With Interferon Beta-1b

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: Interferon beta-1b (Betaseron, BAY86-5046)

• Registration Number: NCT03408093
• Lead Sponsor: Bayer

Brief Summary

The primary objective of the study is to evaluate the adherence to the treatment with interferon beta-1b, in patients diagnosed with isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), or secondary progressive multiple sclerosis (SPMS) who had more than 6 months in treatment.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-02-03
• Primary Completion: 2010-03-30
• Study Completion: 2010-03-30
• Study First Submitted: 2018-01-08
• Study First Submitted QC: 2018-01-17
• Study First Posted: 2018-01-23
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-20
• Last Update Posted: 2018-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients with relapsing-remitting MS (RRMS), secondary progressive MS (SPMS) or patients with a first outbreak or clinically isolated syndrome (CIS) that carry more than 6 months in treatment with interferon beta-1b

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Exclusion Criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Interferon beta-1b	Interferon beta-1b (Betaseron, BAY86-5046)	Patients with CIS, RRMS or SPMS who had more than 6 months in treatment

Primary Outcome Measures

Name	Time	Method
Self-reported adherence to INFb-1b in the previous four weeks assessed by Morisky-Green (MG) test	Four weeks just before baseline visit

Secondary Outcome Measures

Name	Time	Method
Number of patients with MS diagnosis	At baseline
Demographic data	At baseline	Age, sex, marital status, education level, employment status
Time since last relapse	At baseline
Time on INFb-1b therapy	At baseline
Age at first episode and at diagnosis	At baseline
Assessment of general health status using data from a questionnaire or from their clinical history collected by the investigator team	At baseline
Number of patients with adverse events during the last month	Four weeks just before baseline visit
Clinical setting characteristics like existence of MS unit	At baseline	The existence of Multiple Sclerosis Unit was evaluated bearing in mind if the hospital had or had not available a Multiple Sclerosis Unit into the hospital Neurology Department.
Expanded Disability Status Scale (EDSS) to assess the degree of disability caused by MS	At baseline	The EDSS quantifies the disability in eight functional systems (FS) and allows neurologists to assign a level of Functional System in each of them caused by multiple sclerosis.