Injection Management With Betaferon: Influence on Adherence, Patients Satisfaction and Health Related Outcomes (BETAPATH)

Relapsing-Remitting Multiple Sclerosis Clinical Trial

Official title:

Betaferon® Injection Management: Non-interventional Study on Personal Digital Assistant (PDA)Supported Effects on Adherence to a Long-term Injection Therapy (BETAPATH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00902135
• Other study ID #: 14543
• Secondary ID: BF0801DE
• Status: Completed
• Phase: N/A
• First received: May 13, 2009
• Last updated: July 15, 2015
• Start date: May 2009
• Est. completion date: August 2014

Study information

• Verified date: July 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

Aim of the BETAPATH study is to evaluate whether the use of a personal digital assistant (PDA) can improve the adherence of Multiple Sclerosis patients to a therapy with Betaseron. The Personal digital assistant PDA functions as an electronic diary and as an injection reminder.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 702
• Est. completion date: August 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Outpatients with the diagnosis of Multiple Sclerosis and decision by the investigator to prescribe Betaferon.The decision for treatment type and duration is taken before offering the patient the possibility to participate in the study.

Exclusion Criteria:

• Patients, who do not meet the Clinically Isolated Syndrome (CIS) or Relapsing/Remitting Multiple Sclerosis (RRMS) criteria, should not be included.

• Exclusion criteria must be read in conjunction with the German product information.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-Remitting Multiple Sclerosis

Intervention

Drug:
• Interferon beta-1b (Betaseron, BAY86-5046)
Interferon beta-1b (Betaferon) and Personal Digital Assistant together with a reminder
• Interferon beta-1b (Betaseron, BAY86-5046)
Interferon beta-1b (Betaferon) and Personal Digital Assistant without a reminder
• Interferon beta-1b (Betaseron, BAY86-5046)
Interferon beta-1b (Betaferon)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drop out rate over 2 years		24 months	No
Secondary	Disability status		After 3, 6, 12 and 24 months	No
Secondary	Grade of depressiveness		After 3, 6, 12 and 24 months	No
Secondary	Grade of fatigue		After 3, 6, 12 and 24 months	No
Secondary	Quality of life		After 3, 6, 12 and 24 months	No
Secondary	Cognitive status		After 12 and 24 months	No
Secondary	Injection regularity		After 3, 6, 12 and 24 months	No

External Links

•   Click here and search for drug information provided by the FDA.
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