Overview

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

Status:
Completed
Trial end date:
2008-09-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bayer
Treatments:
Interferon beta-1b
Interferon-beta
Interferons
Criteria
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