Open Label Study to Evaluate Effect, Safety and Tolerability of Betaferon Standard Dose of 250µg in Patients of Chinese Origin With Multiple Sclerosis
Information source: Bayer
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Sclerosis
Intervention: Interferon beta-1b (Betaseron, BAY86-5046) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
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.
Clinical Details
Official title: Open Label Study to Evaluate the Effect, Safety and Tolerability of 250µg (8 MIU) Interferon Beta 1b (Betaferon) Given Subcutaneously Every Other Day (for 24 Weeks) in Patients of Chinese Origin With Multiple Sclerosis
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Difference Between the Number of Newly Active Lesions in Magnetic Resonance Imaging (MRI) Per Three Months During the 6-month Treatment Period and the Number of Newly Active Lesions During 3-month Pre-treatment
Secondary outcome: Difference Between the Number of New Gadolinium (Gd)-Enhancing Lesions Per 3 Months During the 6-month Treatment Period and the Number of New Gd-enhancing Lesions During 3-month Pre-treatmentDifference Between the Number of New or Enlarging T2 Lesions Per 3 Months During the 6-month Treatment Period and the Number of New or Enlarging T2 Lesions During 3-month Pre-treatment
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
Minimum age: 16 Years.
Maximum age: 55 Years.
Gender(s): Both.
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
Locations and Contacts
Beijing 100050, China
Beijing 100730, China
Shanghai 200040, China
Additional Information
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Starting date: November 2006
Last updated: May 26, 2013
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