Open label study to evaluate effect, safety and tolerability of Betaferon standard dose of 250µg in patients of Chinese origin with multiple sclerosis

Conditions: Multiple sclerosis
MedDRA version: 17.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2014-004613-93-Outside-EU/EEA

Lead Sponsor: Bayer HealthCare AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 35

Inclusion Criteria

Chinese origin - diagnosis of Relapsing remitting multiple sclerosis or secondary progressive multiple sclerosis
Are the trial subjects under 18? yes
Number of subjects for this age range: 35
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study was to demonstrate that IFNB–1b treatment in MS patients of Chinese origin positively impacts on the course of their disease as evidenced by MRI.<br>;Secondary Objective: A secondary objective was to establish the safety and tolerability of this treatment in this patient population.;Primary end point(s): 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;Timepoint(s) of evaluation of this end point: after 6 months of treatment as compared to 3-month pre-treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. 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<br>2. 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;Timepoint(s) of evaluation of this end point: after 6 months of treatment as compared to the 3-month pre-treatment