- ICH GCP
- US Clinical Trials Registry
- 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
September 29, 2015 updated by: Bayer
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
39
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China, 100050
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Beijing, China, 100730
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Shanghai, China, 200040
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 55 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.)
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Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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)
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after 6 months of treatment as compared to 3-month pre-treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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after 6 months of treatment as compared to 3-month pre-treatment
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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
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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
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after 6 months of treatment as compared to the 3-month pre-treatment
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Volume of Gadolinium-enhancing Lesions at Baseline, Weeks 12 and 24
Time Frame: Baseline, Weeks 12 and 24
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In the categories listed below, "N" signifies the number of subjects evaluable for the timepoints.
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Baseline, Weeks 12 and 24
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Number of New Gadolinium (T1)-Enhancing Lesions at Baseline, Weeks 12 and 24
Time Frame: Baseline, Weeks 12 and 24
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In the categories listed below, "N" signifies the number of subjects evaluable for the timepoints.
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Baseline, Weeks 12 and 24
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Number of T2 Lesions at Baseline, Weeks 12 and 24
Time Frame: Baseline, Weeks 12 and 24
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In the categories listed below, "N" signifies the number of subjects evaluable for the timepoints.
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Baseline, Weeks 12 and 24
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Assessment of Relapses: Relapse Rate
Time Frame: Baseline up to Week 24
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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.
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Baseline up to Week 24
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Assessment of Relapses: Number of Relapses
Time Frame: 3 and 6 months
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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.
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3 and 6 months
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Assessment of Relapses: Percentage of Relapse-free Subjects After 24 Weeks
Time Frame: After 24 weeks
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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.
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After 24 weeks
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Assessment of Relapses: Relapse Severity
Time Frame: Baseline up to Week 24
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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.
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Baseline up to Week 24
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Expanded Disability Status Scale (EDSS)
Time Frame: Pre-treatment on Day 1, Week 24
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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.
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Pre-treatment on Day 1, Week 24
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Percentage of Subjects Without EDSS Progression
Time Frame: Baseline up to Week 24
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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).
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Baseline up to Week 24
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2006
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
August 29, 2006
First Submitted That Met QC Criteria
August 29, 2006
First Posted (Estimate)
August 30, 2006
Study Record Updates
Last Update Posted (Estimate)
October 29, 2015
Last Update Submitted That Met QC Criteria
September 29, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Multiple Sclerosis
- Sclerosis
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Immunologic Factors
- Adjuvants, Immunologic
- Interferons
- Interferon-beta
- Interferon beta-1b
Other Study ID Numbers
- 91386
- MP-00102 (Other Identifier: Company internal)
- 308720 (Other Identifier: Company internal)
- 2014-004613-93 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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