Trial Condition(s):
Multiple Sclerosis, Chronic Progressive
China Betaferon adherence, coping and nurse support study
Bayer Identifier:
15916
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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).
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many locations, China | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
1
Primary Outcome
- Adherence to Betaferon treatment: proportion of patients adhering to Betaferon treatmentTimeframe: at 6, 12, 18 and 24 months
Secondary Outcome
- Ways of Coping Questionnaire (WCQ)Timeframe: at 6, 12, 18 and 24 months
- Hospital Anxiety and Depression Scale (HAD)Timeframe: at 6, 12, 18 and 24 months
Additional Information
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