China Betaferon Adherence, Coping and Nurse Support Study

September 2, 2016 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Many locations, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

MS center located in general hospital

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Interferon beta-1b (Betaseron, BAY86-5046)
All patients will be prescribed with Betaseron and be instructed on treatment by their phisicians

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adherence to Betaferon treatment: proportion of patients adhering to Betaferon treatment
Time Frame: at 6, 12, 18 and 24 months
at 6, 12, 18 and 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Ways of Coping Questionnaire (WCQ)
Time Frame: at 6, 12, 18 and 24 months
at 6, 12, 18 and 24 months
Hospital Anxiety and Depression Scale (HAD)
Time Frame: at 6, 12, 18 and 24 months
at 6, 12, 18 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

September 19, 2011

First Submitted That Met QC Criteria

September 19, 2011

First Posted (Estimate)

September 20, 2011

Study Record Updates

Last Update Posted (Estimate)

September 5, 2016

Last Update Submitted That Met QC Criteria

September 2, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15916
  • BF1110CN (Other Identifier: Company Internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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