Status:
COMPLETED
Open Label Study to Evaluate Effect, Safety and Tolerability of Betaferon Standard Dose of 250µg in Patients of Chinese Origin With Multiple Sclerosis
Lead Sponsor:
Bayer
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
16-55 years
Phase:
PHASE3
Brief 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.
Detailed 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.
Eligibility Criteria
Inclusion
- Chinese origin
- diagnosis of Relapsing remitting multiple sclerosis or secondary progressive multiple sclerosis
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00370071
Start Date
November 1 2006
End Date
September 1 2008
Last Update
October 29 2015
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing, China, 100050
2
Beijing, China, 100730
3
Shanghai, China, 200040