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

• ClinicalTrials.gov Identifier: NCT00370071
• Recruitment Status: Completed
• First Posted: August 30, 2006
• Results First Posted: February 10, 2010
• Last Update Posted: October 29, 2015
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

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.

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

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 39 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: November 2006
• Actual Primary Completion Date: September 2008
• Actual Study Completion Date: September 2008

Arms and Interventions

Arm	Intervention/treatment
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.)

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   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 :

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 [ Time Frame: after 6 months of treatment as compared to 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)
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 [ Time Frame: after 6 months of treatment as compared to the 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
3. Volume of Gadolinium-enhancing Lesions at Baseline, Weeks 12 and 24 [ Time Frame: Baseline, Weeks 12 and 24 ]
   In the categories listed below, "N" signifies the number of subjects evaluable for the timepoints.
4. Number of New Gadolinium (T1)-Enhancing Lesions at Baseline, Weeks 12 and 24 [ Time Frame: Baseline, Weeks 12 and 24 ]
   In the categories listed below, "N" signifies the number of subjects evaluable for the timepoints.
5. Number of T2 Lesions at Baseline, Weeks 12 and 24 [ Time Frame: Baseline, Weeks 12 and 24 ]
   In the categories listed below, "N" signifies the number of subjects evaluable for the timepoints.
6. Assessment of Relapses: Relapse Rate [ Time Frame: Baseline up to Week 24 ]
   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.
7. Assessment of Relapses: Number of Relapses [ Time Frame: 3 and 6 months ]
   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.
8. Assessment of Relapses: Percentage of Relapse-free Subjects After 24 Weeks [ Time Frame: 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.
9. Assessment of Relapses: Relapse Severity [ Time Frame: Baseline up to Week 24 ]
   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.
10. Expanded Disability Status Scale (EDSS) [ Time Frame: Pre-treatment on Day 1, Week 24 ]
    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.
11. Percentage of Subjects Without EDSS Progression [ Time Frame: Baseline up to Week 24 ]
    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).

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 55 Years (Child, Adult)
• Sexes Eligible for Study: All
• 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

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:

Click here to find information about studies related to Bayer Healthcare products conducted in Europe 

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT00370071
• Other Study ID Numbers: 91386; MP-00102 ( Other Identifier: Company internal ); 308720 ( Other Identifier: Company internal ); 2014-004613-93 ( EudraCT Number )
• First Posted: August 30, 2006
• Results First Posted: February 10, 2010
• Last Update Posted: October 29, 2015
• Last Verified: September 2015

Keywords provided by Bayer:

MS

Additional relevant MeSH terms:

Multiple Sclerosis; 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