Trial Condition(s):
Relapsing-Remitting Multiple Sclerosis
Injection management with Betaferon: Influence on Adherence, Patients Satisfaction and Health Related Outcomes (BETAPATH)
Bayer Identifier:
14543
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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.
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, Germany | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Betaferon® injection management: Non-interventional study on personal digital assistant (PDA)supported effects on Adherence to a long-term injection Therapy (BETAPATH)
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
3
Primary Outcome
- Drop out rate over 2 yearsTimeframe: 24 months
Secondary Outcome
- Disability statusTimeframe: After 3, 6, 12 and 24 months
- Grade of depressivenessTimeframe: After 3, 6, 12 and 24 months
- Grade of fatigueTimeframe: After 3, 6, 12 and 24 months
- Quality of lifeTimeframe: After 3, 6, 12 and 24 months
- Cognitive statusTimeframe: After 12 and 24 months
- Injection regularityTimeframe: After 3, 6, 12 and 24 months
Additional Information
Copyright © Bayer
Powered by
