Telephone Interview of Patients That Participated in the the Pivotal Betaferon MS Trial.

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Bayer

Status

Completed

Conditions

Multiple Sclerosis

Treatments

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

Study type

Observational

Funder types

Industry

Identifiers

NCT01031459
14261
20Y-LTF (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to investigate the clinical status of patients who participated in the original pivotal Betaseron study at 20 years after randomized treatment initiationStudy end-points include: Mortality - All-cause mortality - Cause specific mortality - Multiple sclerosis-related mortality EDSS (Expanded Disability Status Scale) Cognition Resource use SPMS (Secondary Progressive Multiple Sclerosis) status Employment history

Enrollment

176 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Previously enrolled in the Betaseron pivotal study protocols TB01-35686 in the US and TB01-35886 in Canada (total, N=372)
  • Patient, caregiver, or legal guardian must provide written informed consent
  • Patient must confirm her/his ability and agreement to participate in the study at the beginning of the phone call

Trial design

176 participants in 1 patient group

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

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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