NCT00370071

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at below P25 for phase_3 multiple-sclerosis

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

February 10, 2010

Completed
Last Updated

October 29, 2015

Status Verified

September 1, 2015

Enrollment Period

1.8 years

First QC Date

August 29, 2006

Results QC Date

October 23, 2009

Last Update Submit

September 29, 2015

Conditions

Multiple Sclerosis

Keywords

MS

Outcome Measures

Primary Outcomes (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

    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)

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

Secondary Outcomes (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

  • 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

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

    Baseline, Weeks 12 and 24

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

    Baseline, Weeks 12 and 24

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

    Baseline, Weeks 12 and 24

  • +6 more secondary outcomes

Study Arms (1)

Interferon beta-1b (Betaseron, BAY86-5046)

EXPERIMENTAL

Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)

Drug: Interferon beta-1b (Betaseron, BAY86-5046)

Interventions

Interferon beta-1b (Betaseron, BAY86-5046)DRUG

Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)

Interferon beta-1b (Betaseron, BAY86-5046)

Eligibility Criteria

Age16 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Chinese origin
  • diagnosis of Relapsing remitting multiple sclerosis or secondary progressive multiple sclerosis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Beijing, 100050, China

Location

Unknown Facility

Beijing, 100730, China

Location

Unknown Facility

Shanghai, 200040, China

Location

Related Links

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1b

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-betaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Results Point of Contact

Title
Therapeutic Area Head
Organization
BAYER
clinical-trials-contact@bayerhealthcare.com

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2006

First Posted

August 30, 2006

Study Start

November 1, 2006

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

October 29, 2015

Results First Posted

February 10, 2010

Record last verified: 2015-09

Locations

CN(3)