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Interferon Beta-1b in Chinese MS Patients
NCT00370071Phase 3
Key facts
- Status
- Completed
- Start
- Nov 2006
- Primary completion
- Sep 2008
- Countries
- 1
- Sponsor
- Bayer
- Modality
- Cytokines & Interferons
- Drugs
- interferon beta-1b
- Conditions
- multiple sclerosis (MS)
01
Overview
Phase 3, open-label, single-arm trial of interferon beta-1b in multiple sclerosis (MS), sponsored by Bayer. 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… Started Nov 2006; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Interferon beta-1b
Interferon beta-1b 250 µg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
03
Who it enrols
Chinese patients with Relapsing remitting or secondary progressive multiple sclerosis, aged 16-55.
04
Endpoints
Primary
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…
Secondary
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
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
Volume of Gadolinium-enhancing Lesions at Baseline, Weeks 12 and 24
Number of New Gadolinium (T1)-Enhancing Lesions at Baseline, Weeks 12 and 24
Number of T2 Lesions at Baseline, Weeks 12 and 24
Assessment of Relapses: Relapse Rate
Assessment of Relapses: Number of Relapses
Assessment of Relapses: Percentage of Relapse-free Subjects After 24 Weeks
05
Results
Primary endpoints met
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