Trial Condition(s):

Multiple Sclerosis

Open label study to evaluate effect, safety and tolerability of Betaferon standard dose of 250µg in patients of Chinese origin with multiple sclerosis

Bayer Identifier:

91386

ClinicalTrials.gov Identifier:

NCT00370071

EudraCT Number:

2014-004613-93

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
39
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Shanghai, China, 200040

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100050

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100730

Status
Completed
 

Trial Design