Study Completed

Relapsing-Remitting Multiple Sclerosis

Bayer Identifier:

14543

ClinicalTrials.gov Identifier:

NCT00902135

EudraCT Number:

Not Available

EU CT Number:

Not Available

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

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A

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

702

Trial Dates

May 2009 - August 2014

Phase

N/A

Could I Receive a placebo

Products

Betaseron (Interferon beta-1b, BAY86-5046)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Many Locations, Germany

Primary Outcome

Drop out rate over 2 years
Time Frame:
24 months
Safety Issue:
No

Secondary Outcome

Disability status
Time Frame:
After 3, 6, 12 and 24 months
Safety Issue:
No
Grade of depressiveness
Time Frame:
After 3, 6, 12 and 24 months
Safety Issue:
No
Grade of fatigue
Time Frame:
After 3, 6, 12 and 24 months
Safety Issue:
No
Quality of life
Time Frame:
After 3, 6, 12 and 24 months
Safety Issue:
No
Cognitive status
Time Frame:
After 12 and 24 months
Safety Issue:
No
Injection regularity
Time Frame:
After 3, 6, 12 and 24 months
Safety Issue:
No

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

N/A

Additional Information

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