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

Bayer

Status and phase

Completed

Phase 3

Conditions

Multiple Sclerosis

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00370071

308720 (Other Identifier)

MP-00102 (Other Identifier)

2014-004613-93 (EudraCT Number)

91386

Details and patient eligibility

About

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.

Full description

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.

Enrollment

39 patients

Sex

All

Ages

16 to 55 years old

Volunteers

No Healthy Volunteers

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