check_circleStudy Completed

Multiple Sclerosis, Chronic Progressive

Bayer Identifier:

15916

ClinicalTrials.gov Identifier:

NCT01436838

EudraCT Number:

Not Available

EU CT Number:

Not Available
China Betaferon adherence, coping and nurse support study

Trial 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.

Key Participants Requirements

Sex

Both

Age

18 - 75 Years
  • - 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)
  • - Known or newly identified contraindication for administration of Betaferon according to Summary of Product Characteristic (SmPC).

Trial summary

Enrollment Goal
110
Trial Dates
March 2012 - December 2015
Phase
N/A
Could I Receive a placebo
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locations, China

Primary Outcome

  • Adherence to Betaferon treatment: proportion of patients adhering to Betaferon treatment
    date_rangeTime Frame:
    at 6, 12, 18 and 24 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Ways of Coping Questionnaire (WCQ)
    date_rangeTime Frame:
    at 6, 12, 18 and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Hospital Anxiety and Depression Scale (HAD)
    date_rangeTime Frame:
    at 6, 12, 18 and 24 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

Prospective study of Betaferon in adherence, coping and nurse support in patients of Chinese origin with multiple sclerosis
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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