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

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:

1. Mortality - All-cause mortality - Cause specific mortality - Multiple sclerosis-related mortality
2. EDSS (Expanded Disability Status Scale)
3. Cognition
4. Resource use
5. SPMS (Secondary Progressive Multiple Sclerosis) status
6. 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)