NCT00902135

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
702

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 14, 2009

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

July 17, 2015

Status Verified

July 1, 2015

Enrollment Period

4.6 years

First QC Date

May 13, 2009

Last Update Submit

July 15, 2015

Conditions

Relapsing-Remitting Multiple Sclerosis

Keywords

Multiple SclerosisInterferon beta-1b

Outcome Measures

Primary Outcomes (1)

  • Drop out rate over 2 years

    24 months

Secondary Outcomes (6)

  • Disability status

    After 3, 6, 12 and 24 months

  • Grade of depressiveness

    After 3, 6, 12 and 24 months

  • Grade of fatigue

    After 3, 6, 12 and 24 months

  • Quality of life

    After 3, 6, 12 and 24 months

  • Cognitive status

    After 12 and 24 months

  • +1 more secondary outcomes

Study Arms (3)

Group 1

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

Group 2

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

Group 3

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

Interventions

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

Interferon beta-1b (Betaferon) and Personal Digital Assistant together with a reminder

Group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, Germany

Location

Related Publications (3)

  • Zettl UK, Bauer-Steinhusen U, Glaser T, Hechenbichler K, Hecker M; Study Group. Comparative evaluation of patients' and physicians' satisfaction with interferon beta-1b therapy. BMC Neurol. 2016 Sep 21;16(1):181. doi: 10.1186/s12883-016-0705-1.

    PMID: 27653529DERIVED

  • Zettl UK, Bauer-Steinhusen U, Glaser T, Czekalla J, Hechenbichler K, Limmroth V, Hecker M. Adherence to Long-Term Interferon Beta-1b Injection Therapy in Patients with Multiple Sclerosis Using an Electronic Diary. Adv Ther. 2016 May;33(5):834-47. doi: 10.1007/s12325-016-0325-6. Epub 2016 Apr 18.

    PMID: 27090116DERIVED

  • Zettl UK, Bauer-Steinhusen U, Glaser T, Hechenbichler K, Limmroth V; Study Group. Evaluation of an electronic diary for improvement of adherence to interferon beta-1b in patients with multiple sclerosis: design and baseline results of an observational cohort study. BMC Neurol. 2013 Sep 6;13:117. doi: 10.1186/1471-2377-13-117.

    PMID: 24011220DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple Sclerosis

Interventions

Interferon beta-1b

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-betaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2009

First Posted

May 14, 2009

Study Start

May 1, 2009

Primary Completion

December 1, 2013

Study Completion

August 1, 2014

Last Updated

July 17, 2015

Record last verified: 2015-07

Locations

DE(1)