Clinical trial NCT00370071: Open Label Study to Evaluate Effect, Safety and Tolerability of Betaferon Standard Dose of 250µg in Patients of Chinese Origin With Multiple Sclerosis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis
Keywords: MS
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-08-30
Enrollment: 39
Sex: ALL
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
timeFrame: after 6 months of treatment as compared to 3-month pre-treatment
Secondary outcomes:
measure: 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
timeFrame: after 6 months of treatment as compared to 3-month pre-treatment
measure: 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
timeFrame: after 6 months of treatment as compared to the 3-month pre-treatment
measure: Volume of Gadolinium-enhancing Lesions at Baseline, Weeks 12 and 24
timeFrame: Baseline, Weeks 12 and 24
measure: Number of New Gadolinium (T1)-Enhancing Lesions at Baseline, Weeks 12 and 24
timeFrame: Baseline, Weeks 12 and 24
measure: Number of T2 Lesions at Baseline, Weeks 12 and 24
timeFrame: Baseline, Weeks 12 and 24
measure: Assessment of Relapses: Relapse Rate
timeFrame: Baseline up to Week 24
measure: Assessment of Relapses: Number of Relapses
timeFrame: 3 and 6 months
measure: Assessment of Relapses: Percentage of Relapse-free Subjects After 24 Weeks
timeFrame: After 24 weeks
measure: Assessment of Relapses: Relapse Severity
timeFrame: Baseline up to Week 24
measure: Expanded Disability Status Scale (EDSS)
timeFrame: Pre-treatment on Day 1, Week 24
measure: Percentage of Subjects Without EDSS Progression
timeFrame: Baseline up to Week 24
Other outcomes:
Locations:
city: Beijing
country: China
city: Beijing
country: China
city: Shanghai
country: China
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: