Depression and Fatigue in MS Patients Treated With Betaferon.

NCT ID: NCT01354665

Last Updated: 2015-01-21

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

567 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-06-30

Brief Summary

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This study aims to evaluate the occurence and severity of fatigue and depression in multiple sclerosis patients and the impact of Betaferon treatment on symptoms alterations.

The study is conducted in routine practice setting hence no interference with standard care takes place.

Pharmacologic treatments of MS-fatigue and depression will also be recorded.

Detailed Description

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Conditions

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Multiple Sclerosis

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 (Betaferon, BAY86-5046)

Intervention Type BIOLOGICAL

Patients treated with regular dose of Betaferon injections (250 micrograms subcutaneously every other day) under routine practice setting.

Interventions

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

Patients treated with regular dose of Betaferon injections (250 micrograms subcutaneously every other day) under routine practice setting.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Relapsing-remitting multiple sclerosis
* Age 18+
* Patients initiating Betaferon treatment

Exclusion Criteria

* Patients previously treated with any immunomodulatory drug
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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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Poland

Site Status

Countries

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Poland

Other Identifiers

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BF1012PL

Identifier Type: OTHER

Identifier Source: secondary_id

15307

Identifier Type: -

Identifier Source: org_study_id

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