Phase 3
Completed N=39
Open Label Study to Evaluate Effect, Safety and Tolerability of Betaferon Standard Dose of 250µg in Patients of Chinese Origin With Multiple Sclerosis
Source: ClinicalTrials.gov NCT00370071 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Feb 2010
Primary outcomePrimary: 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 — -1.5 lesions — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 Pre-treatment |
-1.5 | <0.0001 sig |
| 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 |
-0.5 | <0.0001 sig |
| SECONDARY 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 |
— | 0.0017 sig |
| SECONDARY Volume of Gadolinium-enhancing Lesions at Baseline, Weeks 12 and 24 |
585; 93; 648 | <0.0001 sig |
| SECONDARY Number of New Gadolinium (T1)-Enhancing Lesions at Baseline, Weeks 12 and 24 |
2.8; 0.5; 0.8 | — |
| SECONDARY Number of T2 Lesions at Baseline, Weeks 12 and 24 |
48.7; 48.8; 44.6 | — |
| SECONDARY Assessment of Relapses: Relapse Rate |
0.38 | — |
| SECONDARY Assessment of Relapses: Number of Relapses |
6; 7 | — |
| SECONDARY Assessment of Relapses: Percentage of Relapse-free Subjects After 24 Weeks |
84.6 | — |
| SECONDARY Assessment of Relapses: Relapse Severity |
1; 12 | — |
| SECONDARY Expanded Disability Status Scale (EDSS) |
2.06; 1.81 | — |
| SECONDARY Percentage of Subjects Without EDSS Progression |
87.2 | — |
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
- 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
Data sourced from ClinicalTrials.gov (NCT00370071). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.