China Betaferon Adherence, Coping and Nurse Support Study

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01436838
• Collaborator: (none)
• Enrollment: 110
• Location: 1
• Duration (Months): 45
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis, Chronic Progressive	Drug: Interferon beta-1b (Betaseron, BAY86-5046)

Study Design

• Study Type: Observational
• Actual Enrollment: 110 participants
• 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
• Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Group 1	Drug: Interferon beta-1b (Betaseron, BAY86-5046); All patients will be prescribed with Betaseron and be instructed on treatment by their phisicians

Outcome Measures

Primary Outcome Measures

1. Adherence to Betaferon treatment: proportion of patients adhering to Betaferon treatment [at 6, 12, 18 and 24 months]

Secondary Outcome Measures

1. Ways of Coping Questionnaire (WCQ) [at 6, 12, 18 and 24 months]

2. Hospital Anxiety and Depression Scale (HAD) [at 6, 12, 18 and 24 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1		Many locations		China

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT01436838
• Other Study ID Numbers: 15916; BF1110CN
• First Posted: Sep 20, 2011
• Last Update Posted: Sep 5, 2016
• Last Verified: Aug 1, 2016

• Keywords provided by Bayer: Relapsing-Remitting Multiple Sclerosis; Secondary Progressive Multiple Sclerosis
• Additional relevant MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis; Interferons; Interferon-beta; Interferon beta-1b

Study Results

No Results Posted as of Sep 5, 2016