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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:
Bayer
ClinicalTrials.gov Identifier:
NCT00370071
First received: August 29, 2006
Last updated: May 26, 2013
Last verified: May 2013
  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


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
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:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00370071     History of Changes
Other Study ID Numbers: 91386, MP-00102, 308720
Study First Received: August 29, 2006
Results First Received: October 23, 2009
Last Updated: May 26, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Bayer:
MS

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

ClinicalTrials.gov processed this record on November 25, 2014