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China Betaferon Adherence, Coping and Nurse Support Study

This study is currently recruiting participants.
Verified April 2013 by Bayer
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01436838
First received: September 19, 2011
Last updated: April 18, 2013
Last verified: April 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 100
Study Start Date: March 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 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

  Eligibility

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01436838

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

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

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Director, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01436838     History of Changes
Other Study ID Numbers: 15916, BF1110CN
Study First Received: September 19, 2011
Last Updated: April 18, 2013
Health Authority: China: None

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

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

ClinicalTrials.gov processed this record on May 16, 2013