A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron®

Phase 1

• Conditions: Clinically-isolated syndrome (CIS) and multiple sclerosis (MS); MedDRA version: 20.0 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0 Level: PT Classification code 10071068 Term: Clinically isolated syndrome System Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-001176-31-GB
• Lead Sponsor: Bayer AG,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-21
• Study Completion: 2018-05-22
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 261

Inclusion Criteria

1.All subjects who were treated at least once in BENEFIT study 304747 are eligible for inclusion in the BENEFIT 15 study. Also, those original BENEFIT subjects who prematurely discontinued study participation in any of the prior BENEFIT studies areeligible for inclusion in the BENEFIT 15 study.
2.Subjects with signed written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Subjects who, according to the investigator’s judgment, have medical, psychiatric, or other conditions that compromise the subject’s ability to understand the purpose of the study
2.Subjects who meet any of the following criteria will only be excluded from the MRI assessment. However, these subjects should be encouraged to nevertheless participate in the clinical part of the study:
3.Pregnant or nursing (including pumping for storage and feeding)
4.Contraindications to MRI examination (e.g., inability to hold breath, severearrhythmias, very low cardiac output, severe claustrophobia, or subjects with implanted defibrillators or other metallic devices not approved for MRI)
5.Suspected clinical instability or unpredictability of the clinical course during the study (e.g., due to previous surgery or acute stroke)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified