China Betaferon Adherence, Coping and Nurse Support Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01436838
Recruitment Status : Completed
First Posted : September 20, 2011
Last Update Posted : September 5, 2016
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment
Multiple Sclerosis, Chronic Progressive Drug: Interferon beta-1b (Betaseron, BAY86-5046)

Study Type : Observational
Actual Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study of Betaferon in Adherence, Coping and Nurse Support in Patients of Chinese Origin With Multiple Sclerosis
Study Start Date : March 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Adherence to Betaferon treatment: proportion of patients adhering to Betaferon treatment [ Time Frame: at 6, 12, 18 and 24 months ]

Secondary Outcome Measures :
  1. Ways of Coping Questionnaire (WCQ) [ Time Frame: at 6, 12, 18 and 24 months ]
  2. Hospital Anxiety and Depression Scale (HAD) [ Time Frame: at 6, 12, 18 and 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
MS center located in general hospital

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01436838

Many locations, China
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer Identifier: NCT01436838     History of Changes
Other Study ID Numbers: 15916
BF1110CN ( Other Identifier: Company Internal )
First Posted: September 20, 2011    Key Record Dates
Last Update Posted: September 5, 2016
Last Verified: August 2016

Keywords provided by Bayer:
Relapsing-Remitting Multiple Sclerosis
Secondary Progressive Multiple Sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon beta-1b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic