Noninterventional Study Assessing Cognitive Function and Physical Activity in People With Multiple Sclerosis

NCT ID: NCT01491100

Last Updated: 2018-04-05

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

1085 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2017-04-05

Brief Summary

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Study assessing cognitive function and physical activity in people with relapsing remitting multiple sclerosis.

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 (Betaseron, BAY86-5046)

Intervention Type DRUG

Patients treated with regular dose subcutaneously administered, according to the label and to clinical routine practice.

Interventions

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

Patients treated with regular dose subcutaneously administered, according to the label and to clinical routine practice.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with Relapsing Remitting Multiple Sclerosis (RRMS), and treated with Betaferon, with the decision for treatment made at the discretion of the attending physician, documented with a prescription of Betaferon by the physician
* EDSS 0 - 6
* Written informed consent

Exclusion Criteria

* Patients who do not meet the local indication criteria for Betaferon treatment.
* Contraindications listed in the local SmPCs have to be considered.
* Patients with a history of severe head trauma.
* Patients with alcohol and/or drug abuse.
* Patients with mental retardation.
* Patients with learning disability.
Minimum Eligible Age

12 Years

Maximum Eligible Age

70 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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Multiple Locations, , Albania

Site Status

Multiple Locations, , Algeria

Site Status

Multiple Locations, , Argentina

Site Status

Multiple Locations, , Belgium

Site Status

Multiple Locations, , Czechia

Site Status

Multiple Locations, , Egypt

Site Status

Multiple Locations, , France

Site Status

Multiple Locations, , Germany

Site Status

Multiple Locations, , Greece

Site Status

Multiple Locations, , Hungary

Site Status

Multiple Locations, , Israel

Site Status

Multiple Locations, , Kazakhstan

Site Status

Multiple Locations, , Netherlands

Site Status

Multiple Locations, , Portugal

Site Status

Multiple Locations, , Saudi Arabia

Site Status

Multiple Locations, , Tunisia

Site Status

Multiple Locations, , Turkey (Türkiye)

Site Status

Countries

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Albania Algeria Argentina Belgium Czechia Egypt France Germany Greece Hungary Israel Kazakhstan Netherlands Portugal Saudi Arabia Tunisia Turkey (Türkiye)

Other Identifiers

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BF1101

Identifier Type: OTHER

Identifier Source: secondary_id

16036

Identifier Type: -

Identifier Source: org_study_id

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