check_circleStudy Completed

Multiple sclerosis

Bayer Identifier:

308272

ClinicalTrials.gov Identifier:

NCT00206635

EudraCT Number:

Not Available

EU CT Number:

Not Available
Betaseron 16-Year Long-Term Follow-Up (LTF) in Patients With Relapsing-Remitting Multiple Sclerosis

Trial purpose

The purpose of this follow-up study is to look carefully at the long-term course of multiple sclerosis (MS) and possibly the long-term effects of Betaseron in the patients who were previously enrolled in the original North American study that led to the marketing approval of Betaseron.

Key Participants Requirements

Sex

Both

Age

33 Years
  • - Patients in North America have to have been previously enrolled in the original Betaseron trial from 1988-1993
    - Be able to understand the consent form (or have a guardian who can)
  • - North American patients cannot be included if they have not participated in the original Betaseron trial from 1988-1993

Trial summary

Enrollment Goal
432
Trial Dates
January 2005 - December 2005
Phase
N/A
Could I Receive a placebo
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Canada
Completed
Many Locations, Canada
Completed
Many Locations, Canada
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States
Completed
Many Locations, United States

Primary Outcome

  • Description of long term course of disease
    date_rangeTime Frame:
    16 years
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    Safety Issue:
    None

Secondary Outcome

  • Comparison to natural history cohort
    date_rangeTime Frame:
    16 years
    enhanced_encryption
    Safety Issue:
    None

Trial design

A long-term follow up of patients enrolled in the pivotal study of Betaseron® (interferon beta 1b) in relapsing-remitting multiple sclerosis
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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