BetaPlus Survey - Observational Study to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon® by Using Elements of the BetaPlus Program

NCT ID: NCT01233245

Last Updated: 2012-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1077 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-04-30

Study Completion Date

2009-06-30

Brief Summary

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This is an observational survey to assess the factors that influence adherence to Betaferon therapy in multiple sclerosis patients using elements of the BetaPlus support program, including the nurse support and auto-injectors. The patients were evaluated under normal clinical practice and were asked to fill out the quality of life FAMS questionnaire, Coping processes (WCQ - Ways of Coping Questionnaire) and depression questionnaire CES-D.

Detailed Description

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Conditions

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Relapsing Remitting MS (RRMS) Secondary Progressive MS (SPMS)

Keywords

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Multiple Sclerosis Adherence Interferon beta-1b Coping Styles

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

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

Intervention Type DRUG

250 µg, sub-cutaneously, on alternate days

Interventions

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

250 µg, sub-cutaneously, on alternate days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Relapsing-remitting MS (RRMS) or secondary-progressive MS (SPMS)
* Previous treatment with disease modifying drugs
* Adjustment of disease modifying treatment necessary at the discretion of the investigator
* Switch to Betaferon at least 1 month but not longer than 3 months prior to inclusion

Exclusion Criteria

* Patients not fulfilling the indications in the local prescribing information
* Refusal to sign inform consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Bayer Schering Pharma AG

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Czechia

Site Status

Many Locations, , France

Site Status

Many Locations, , Germany

Site Status

Many Locations, , Iran

Site Status

Many Locations, , Israel

Site Status

Many Locations, , Italy

Site Status

Many Locations, , Jordan

Site Status

Many Locations, , Lebanon

Site Status

Many Locations, , Netherlands

Site Status

Many Locations, , Portugal

Site Status

Many Locations, , Saudi Arabia

Site Status

Many Locations, , South Korea

Site Status

Many Locations, , Spain

Site Status

Many Locations, , Taiwan

Site Status

Many Locations, , Turkey (Türkiye)

Site Status

Countries

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Czechia France Germany Iran Israel Italy Jordan Lebanon Netherlands Portugal Saudi Arabia South Korea Spain Taiwan Turkey (Türkiye)

References

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Pozzilli C, Schweikert B, Ecari U, Oentrich W; BetaPlus Study group. Supportive strategies to improve adherence to IFN beta-1b in multiple sclerosis--results of the betaPlus observational cohort study. J Neurol Sci. 2011 Aug 15;307(1-2):120-6. doi: 10.1016/j.jns.2011.04.026. Epub 2011 Jun 1.

Reference Type RESULT
PMID: 21636099 (View on PubMed)

Other Identifiers

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BF0704

Identifier Type: OTHER

Identifier Source: secondary_id

14192

Identifier Type: -

Identifier Source: org_study_id