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Portuguese Observational Survey to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon by Using Elements of the BetaPlus Program - Nurse Support, Auto-injectors

NCT ID: NCT01235455

Last Updated: 2012-11-01

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

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-08-31

Study Completion Date

2011-05-31

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) and depression questionnaire CES-D.

Detailed Description

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Conditions

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Relapsing Remitting Multiple Sclerosis (RRMS) Secondary Progressive Multiple Sclerosis (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 Portugal SA

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Portugal

Site Status

Countries

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Portugal

Other Identifiers

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BF0710PT

Identifier Type: OTHER

Identifier Source: secondary_id

14235

Identifier Type: -

Identifier Source: org_study_id