China Betaferon Adherence, Coping and Nurse Support Study

Multiple Sclerosis, Chronic Progressive Clinical Trial

Official title:

Prospective Study of Betaferon in Adherence, Coping and Nurse Support in Patients of Chinese Origin With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01436838
• Other study ID #: 15916
• Secondary ID: BF1110CN
• Status: Completed
• Phase: N/A
• First received: September 19, 2011
• Last updated: September 2, 2016
• Start date: March 2012
• Est. completion date: December 2015

Study information

• Verified date: August 2016
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: None
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Sclerosis

Intervention

Drug:
• Interferon beta-1b (Betaseron, BAY86-5046)
All patients will be prescribed with Betaseron and be instructed on treatment by their phisicians

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to Betaferon treatment: proportion of patients adhering to Betaferon treatment		at 6, 12, 18 and 24 months	No
Secondary	Ways of Coping Questionnaire (WCQ)		at 6, 12, 18 and 24 months	No
Secondary	Hospital Anxiety and Depression Scale (HAD)		at 6, 12, 18 and 24 months	No

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.