Betaferon Use in Children and Adolescents With Multiple Sclerosis

NCT ID: NCT03577977

Last Updated: 2018-07-11

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

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-01

Study Completion Date

2009-04-15

Brief Summary

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The objective of this study is to determine efficacy, safety and tolerability of interferon beta-1b for multiple sclerosis (MS) in children and adolescents

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

RETROSPECTIVE

Study Groups

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Patients treated with Betaferon

Patients with very early onset of MS, who received at least one injection of interferon beta-1b as prescribed by the treating physician, before the age of 18.

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

Intervention Type DRUG

Betaferon was injected subcutaneously as prescribed by the treating physician.

Interventions

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

Betaferon was injected subcutaneously as prescribed by the treating physician.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients with symptoms consistent with the diagnosis of a demyelinating CNS disease
* patients who received at least one injection of Betaferon before age 18 (before their 18th birthday)
* recorded use of at least one dose of Betaferon before January 1, 2008

Exclusion Criteria

* Diagnosis other then MS or a demyelinating CNS disease
Maximum 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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Multiple Locations, , Russia

Site Status

Countries

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Russia

Other Identifiers

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2008/01743

Identifier Type: -

Identifier Source: org_study_id

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