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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

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
CompletedPhase 3Relapsing and progressiveNCT003700712014-004613-93

What it found

Met its main goal

The main measure showed a statistically significant benefit.

MeasureEstimate95% CIp
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 <0.0001

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

Results by group

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

after 6 months of treatment as compared to 3-month pre-treatment

GroupValueIntervalNumber analysed
Interferon Beta-1b (Betaseron, BAY86-5046)-1.5 lesions-35–6.538

p = <0.0001

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Interferon Beta-1b (Betaseron, BAY86-5046)390 (0.0%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main 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

    after 6 months of treatment as compared to 3-month pre-treatment

    MRI lesions

Other measures (11)

  • 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

    after 6 months of treatment as compared to 3-month pre-treatment

    MRI lesions

  • 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

    after 6 months of treatment as compared to the 3-month pre-treatment

    MRI lesions

  • Volume of Gadolinium-enhancing Lesions at Baseline, Weeks 12 and 24

    Baseline, Weeks 12 and 24

    MRI lesions

  • Number of New Gadolinium (T1)-Enhancing Lesions at Baseline, Weeks 12 and 24

    Baseline, Weeks 12 and 24

    MRI lesions

  • Number of T2 Lesions at Baseline, Weeks 12 and 24

    Baseline, Weeks 12 and 24

    MRI lesions

  • Assessment of Relapses: Relapse Rate

    Baseline up to Week 24

    Relapses

  • Assessment of Relapses: Number of Relapses

    3 and 6 months

    Relapses

  • Assessment of Relapses: Percentage of Relapse-free Subjects After 24 Weeks

    After 24 weeks

    Relapses

  • Assessment of Relapses: Relapse Severity

    Baseline up to Week 24

    Disability progressionRelapses

  • Expanded Disability Status Scale (EDSS)

    Pre-treatment on Day 1, Week 24

    Disability progressionWalking and mobility

Who could take part

Relapsing and progressive · 16 to 55

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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Related trials

History

    1. Started

      Nov 2006

    2. Main results due

      Sept 2008

    3. Finished

      Sept 2008

    4. Results posted

      Feb 2010

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