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

This study is currently recruiting participants.

Verified April 2013 by Bayer

Sponsor:

Information provided by:

Bayer

ClinicalTrials.gov Identifier:

NCT00902135

First received: May 13, 2009

Last updated: April 9, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

May 13, 2009

Last Updated Date

April 9, 2013

Start Date ^ICMJE

May 2009

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Drop out rate over 2 years [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00902135 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Disability status [ Time Frame: After 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
Grade of depressiveness [ Time Frame: After 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
Grade of fatigue [ Time Frame: After 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: After 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
Cognitive status [ Time Frame: After 12 and 24 months ] [ Designated as safety issue: No ]
Injection regularity [ Time Frame: After 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Adult female and male Clinically Isolated Syndrome (CIS) and relapsing-remitting multiple sclerosis (RRMS) patients who are at least 18 years of age, have started a treatment with Betaferon based on clinical decision by the treating neurologist and have completed the dose titration, will be documented after the therapy decision has been made.

The prescription of the medicine must be clearly independent from the decision to include the patient in the study.

Condition ^ICMJE

Relapsing-Remitting Multiple Sclerosis

Intervention ^ICMJE

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

Study Group/Cohort (s)

Group 1
Intervention: Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Group 2
Intervention: Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Group 3
Intervention: Drug: Interferon beta-1b (Betaseron, BAY86-5046)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

800

Estimated Completion Date

March 2014

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Bayer Clinical Trials Contact

clinical-trials-contact@bayerhealthcare.com

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00902135

Other Study ID Numbers ^ICMJE

14543, BF0801DE

Has Data Monitoring Committee

Responsible Party

Medical Director, Bayer Vital GmbH

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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