Open Label Study to Evaluate Effect, Safety and Tolerability of Betaferon Standard Dose of 250µg in Patients of Chinese Origin With Multiple Sclerosis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-09-30

Brief Summary

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The purpose of this study is to determine if the study drug is effective and safe in the treatment of Multiple Sclerosis (MS) in patients of Chinese origin.

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Detailed Description

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The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany.

Bayer HealthCare AG, Germany is the sponsor of the trial.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)

Interventions

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

Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Chinese origin
* diagnosis of Relapsing remitting multiple sclerosis or secondary progressive multiple sclerosis

Exclusion Criteria

* Any disease other than Multiple Sclerosis (MS) that could better explain the patients signs and symptoms
* HIV (human immunodeficiency virus) infections
* Hepatitis A
* Syphilis
* immunodeficiency
* rheumatic disease or Sjogren syndrome
* heart disease
* severe depression
* pregnancy or lactation
* conditions interfering with Magnetic Resonance Imaging (MRI)
* Gadolinium DTPA (Gadovist, contrast agent) allergy
* allergy against human proteins, paracetamol, acetaminophen and ibuprofen intolerance
* participation in other trial

Minimum Eligible Age

16 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No