Open Label Study to Evaluate Effect, Safety and Tolerability of Betaferon Standard Dose of 250µg in Patients of Chinese Origin With Multiple Sclerosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00370071
First received: August 29, 2006
Last updated: September 29, 2015
Last verified: September 2015
  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.

Condition Intervention Phase
Multiple Sclerosis
Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 [ Time Frame: after 6 months of treatment as compared to 3-month pre-treatment ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • 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 [ Time Frame: after 6 months of treatment as compared to 3-month pre-treatment ] [ Designated as safety issue: No ]
    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)

  • 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 [ Time Frame: after 6 months of treatment as compared to the 3-month pre-treatment ] [ Designated as safety issue: No ]
    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

  • Volume of Gadolinium-enhancing Lesions at Baseline, Weeks 12 and 24 [ Time Frame: Baseline, Weeks 12 and 24 ] [ Designated as safety issue: No ]
    In the categories listed below, "N" signifies the number of subjects evaluable for the timepoints.

  • Number of New Gadolinium (T1)-Enhancing Lesions at Baseline, Weeks 12 and 24 [ Time Frame: Baseline, Weeks 12 and 24 ] [ Designated as safety issue: No ]
    In the categories listed below, "N" signifies the number of subjects evaluable for the timepoints.

  • Number of T2 Lesions at Baseline, Weeks 12 and 24 [ Time Frame: Baseline, Weeks 12 and 24 ] [ Designated as safety issue: No ]
    In the categories listed below, "N" signifies the number of subjects evaluable for the timepoints.

  • Assessment of Relapses: Relapse Rate [ Time Frame: Baseline up to Week 24 ] [ Designated as safety issue: No ]
    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.

  • Assessment of Relapses: Number of Relapses [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    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.

  • Assessment of Relapses: Percentage of Relapse-free Subjects After 24 Weeks [ Time Frame: After 24 weeks ] [ Designated as safety issue: No ]
    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.

  • Assessment of Relapses: Relapse Severity [ Time Frame: Baseline up to Week 24 ] [ Designated as safety issue: No ]
    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.

  • Expanded Disability Status Scale (EDSS) [ Time Frame: Pre-treatment on Day 1, Week 24 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Subjects Without EDSS Progression [ Time Frame: Baseline up to Week 24 ] [ Designated as safety issue: No ]
    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).


Enrollment: 39
Study Start Date: November 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interferon beta-1b (Betaseron, BAY86-5046)
Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)

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

Ages Eligible for Study:   16 Years to 55 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00370071

Locations
China
Beijing, China, 100050
Beijing, China, 100730
Shanghai, China, 200040
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00370071     History of Changes
Other Study ID Numbers: 91386  MP-00102  308720  2014-004613-93 
Study First Received: August 29, 2006
Results First Received: October 23, 2009
Last Updated: September 29, 2015
Health Authority: China: Food and Drug Administration

Keywords provided by Bayer:
MS

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferons
Interferon-beta
Interferon beta-1b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on July 21, 2016