check_circleStudy Completed

Multiple sclerosis

Bayer Identifier:

91386

ClinicalTrials.gov Identifier:

NCT00370071

EudraCT Number:

2014-004613-93

EU CT Number:

Not Available
Open label study to evaluate effect, safety and tolerability of Betaferon standard dose of 250µg in patients of Chinese origin with multiple sclerosis

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

16 - 55 Years
  • - Chinese origin
    - diagnosis of Relapsing remitting multiple sclerosis or secondary progressive multiple sclerosis
  • - 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

Trial summary

Enrollment Goal
39
Trial Dates
November 2006 - September 2008
Phase
Phase 3
Could I Receive a placebo
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Shanghai, 200040, China
Completed
Beijing, 100050, China
Completed
Beijing, 100730, China
Completed
Beijing, 100730, China

Primary Outcome

  • 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
    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)
    date_rangeTime Frame:
    after 6 months of treatment as compared to 3-month pre-treatment
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • 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
    This secondary endpoint (component of the primary endpoint) was calculated by subtracting the number of new Gd-enhancing lesions during the 3-month pre-treatment period from the cumulative number of new Gd-enhancing lesions during the 6-month treatment period divided by 2 (number of new Gd-enhancing lesions per three months)
    date_rangeTime Frame:
    after 6 months of treatment as compared to 3-month pre-treatment
    enhanced_encryption
    Safety Issue:
    No
  • 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
    This secondary endpoint (component of the primary endpoint) was calculated by subtracting the number of new or enlarging T2 lesions during the 3-month pre-treatment period from the cumulative number of new or enlarging T2 lesions during the 6-month treatment period divided by 2 (number of new T2 lesions per three months) based on non-enhancing lesions on T1 weighted scans
    date_rangeTime Frame:
    after 6 months of treatment as compared to the 3-month pre-treatment
    enhanced_encryption
    Safety Issue:
    No
  • Volume of Gadolinium-enhancing Lesions at Baseline, Weeks 12 and 24
    In the categories listed below, “N” signifies the number of subjects evaluable for the timepoints.
    date_rangeTime Frame:
    Baseline, Weeks 12 and 24
    enhanced_encryption
    Safety Issue:
    No
  • Number of New Gadolinium (T1)-enhancing Lesions at Baseline, Weeks 12 and 24
    In the categories listed below, “N” signifies the number of subjects evaluable for the timepoints.
    date_rangeTime Frame:
    Baseline, Weeks 12 and 24
    enhanced_encryption
    Safety Issue:
    No
  • Number of T2 Lesions at Baseline, Weeks 12 and 24
    In the categories listed below, “N” signifies the number of subjects evaluable for the timepoints.
    date_rangeTime Frame:
    Baseline, Weeks 12 and 24
    enhanced_encryption
    Safety Issue:
    No
  • Assessment of Relapses: Relapse Rate
    A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical event. The abnormality must be present for at least 24 hours and occur in the absence of fever (axillary temperature more than (>) 37.5 degree celsius / 99.5 degree fahrenheit) or known infection. A relapse must be confirmed by a documented report from a physician or by objective assessment. The relapse rate was calculated on an annualized basis. Annualized relapse rate is the average number of relapses in a year calculated by negative binomial regression as the sum of confirmed relapses of all subjects in the group divided by the sum of the number of days on study of all subjects in the group and multiplied by 365.25.
    date_rangeTime Frame:
    Baseline up to Week 24
    enhanced_encryption
    Safety Issue:
    No
  • Assessment of Relapses: Number of Relapses
    A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical event. The abnormality must be present for at least 24 hours and occur in the absence of fever (axillary temperature >37.5 degree celsius / 99.5 degree fahrenheit) or known infection. A relapse must be confirmed by a documented report from a physician or by objective assessment. In the categories listed below, “N” signifies the number of subjects evaluable for the timepoints, and same subjects were counted more than once under each category.
    date_rangeTime Frame:
    3 and 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Assessment of Relapses: Percentage of Relapse-free Subjects After 24 Weeks
    A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical event. The abnormality must be present for at least 24 hours and occur in the absence of fever (axillary temperature >37.5 degree celsius / 99.5 degree fahrenheit) or known infection. A relapse must be confirmed by a documented report from a physician or by objective assessment.
    date_rangeTime Frame:
    After 24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Assessment of Relapses: Relapse Severity
    A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical event. The abnormality must be present for at least 24 hours and occur in the absence of fever (axillary temperature >37.5 degree celsius / 99.5 degree fahrenheit) or known infection. A relapse must be confirmed by a documented report from a physician or by objective assessment. A major relapse was defined based on changes on EDSS with the following additional criteria to be met: objective neurological impairment, correlating with the subject’s reported symptoms, defined as either increase in at least one of the functional systems of the EDSS score or increase of the total EDSS score. Relapses which did not meet the criteria of major relapses were considered as non-major.
    date_rangeTime Frame:
    Baseline up to Week 24
    enhanced_encryption
    Safety Issue:
    No
  • Expanded Disability Status Scale (EDSS)
    The EDSS is a scale based on the standardized neurological examination which comprised of optic, brain stem/cranial nerves, pyramidal, cerebellar, sensory, vegetative, and cerebral functions, as well as walking ability. The EDSS scores range from 0.0 (normal) to 10.0 (dead). A score of 2 to 3 indicates minimal to moderate disability.
    date_rangeTime Frame:
    Pre-treatment on Day 1, Week 24
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of Subjects Without EDSS Progression
    The EDSS is a scale based on the standardized neurological examination which comprised of optic, brain stem/cranial nerves, pyramidal, cerebellar, sensory, vegetative, and cerebral functions, as well as walking ability.The EDSS scores range from 0.0 (normal) to 10.0 (dead). A score of 2 to 3 indicates minimal to moderate disability. An EDSS progression was defined as increase in EDSS greater than or equal to (>=) 1.0 points (in the treatment period as compared to baseline).
    date_rangeTime Frame:
    Baseline up to Week 24
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

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