China Betaferon Adherence, Coping and Nurse Support Study

Non-adherence reduces treatment benefit and can bias the assessment of treatment efficacy thereby involving safety risks for the patient and influencing health cost-effectiveness. This observational study will concentrate upon the role of MS nurses in influencing adherence. This study will examine the influence of initial and subsequent periodic nurse interviews which aim to improve adherence to Betaferon® treatment.

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Key information

Conditions

Multiple Sclerosis, Chronic Progressive Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Relapsing-remitting multiple scelrosis (RRMS) and secondary progressive multiple sclerosis (SPMS) patients
Having Betaferon treatment, including patients who are

First time using; or
Re-staring; or
Switching from other diseases modifying drugs (DMDs)

Exclusion criteria

Known or newly identified contraindication for administration of Betaferon according to Summary of Product Characteristic (SmPC).

Treatment and study plan

Interferon beta-1b (Betaseron, BAY86-5046)

Drug

All patients will be prescribed with Betaseron and be instructed on treatment by their phisicians

Primary outcomes

Adherence to Betaferon treatment: proportion of patients adhering to Betaferon treatment

Time frame: at 6, 12, 18 and 24 months

Secondary outcomes

Ways of Coping Questionnaire (WCQ)

Time frame: at 6, 12, 18 and 24 months
Hospital Anxiety and Depression Scale (HAD)

Time frame: at 6, 12, 18 and 24 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Prospective Study of Betaferon in Adherence, Coping and Nurse Support in Patients of Chinese Origin With Multiple Sclerosis

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Sep 20, 2011
Registry last updated: Sep 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed