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
Overview
- Phase
- Phase 3
- Intervention
- Interferon beta-1b (Betaseron, BAY86-5046)
- Conditions
- Multiple Sclerosis
- Sponsor
- Bayer
- Enrollment
- 39
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility 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
- •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
Arms & Interventions
Interferon beta-1b (Betaseron, BAY86-5046)
Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
Intervention: Interferon beta-1b (Betaseron, BAY86-5046)
Outcomes
Primary Outcomes
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
Time Frame: after 6 months of treatment as compared to 3-month pre-treatment
The primary efficacy variable was calculated by subtracting the number of newly active lesions during the 3-month pre-treatment period from the cumulative number of newly active lesions during the 6-month treatment period divided by 2 (number of newly active lesions per three months, new lesion frequency per 3 months)
Secondary Outcomes
- Difference 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(after 6 months of treatment as compared to the 3-month pre-treatment)
- Assessment of Relapses: Percentage of Relapse-free Subjects After 24 Weeks(After 24 weeks)
- 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-treatment(after 6 months of treatment as compared to 3-month pre-treatment)
- Assessment of Relapses: Relapse Rate(Baseline up to Week 24)
- Assessment of Relapses: Relapse Severity(Baseline up to Week 24)
- Percentage of Subjects Without EDSS Progression(Baseline up to Week 24)
- Volume of Gadolinium-enhancing Lesions at Baseline, Weeks 12 and 24(Baseline, Weeks 12 and 24)
- Number of New Gadolinium (T1)-Enhancing Lesions at Baseline, Weeks 12 and 24(Baseline, Weeks 12 and 24)
- Assessment of Relapses: Number of Relapses(3 and 6 months)
- Number of T2 Lesions at Baseline, Weeks 12 and 24(Baseline, Weeks 12 and 24)
- Expanded Disability Status Scale (EDSS)(Pre-treatment on Day 1, Week 24)