China Betaferon Adherence, Coping and Nurse Support Study

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: September 19, 2011
Last updated: October 23, 2015
Last verified: October 2015
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 Intervention
Multiple Sclerosis, Chronic Progressive
Drug: Interferon beta-1b (Betaseron, BAY86-5046)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Adherence to Betaferon treatment: proportion of patients adhering to Betaferon treatment [ Time Frame: at 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ways of Coping Questionnaire (WCQ) [ Time Frame: at 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Scale (HAD) [ Time Frame: at 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: March 2012
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Interferon beta-1b (Betaseron, BAY86-5046)
All patients will be prescribed with Betaseron and be instructed on treatment by their phisicians


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01436838

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

Additional Information:
Responsible Party: Bayer Identifier: NCT01436838     History of Changes
Other Study ID Numbers: 15916  BF1110CN 
Study First Received: September 19, 2011
Last Updated: October 23, 2015
Health Authority: China: None

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

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Interferon beta-1b
Adjuvants, Immunologic
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on May 22, 2016