BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies

Bayer

Status and phase: Completed; Phase 4

Conditions: Multiple Sclerosis

Treatments: Other: Blood sampling; Other: Brain MRI

Study type: Interventional

Funder types: Industry

Identifiers

NCT03269175

2017-001176-31 (EudraCT Number)

19215

Details and patient eligibility

About

The purpose of this study is to obtain long-term clinical data from patients approximately 15 years after their first clinical event, who participated in the former BENEFIT 304747 study and were treated at least once within that study.

This study will collect clinical information on the disease course, on disability, relapses, cognitive function over time, quality of life, depression, fatigue, resource use, and employment status. In addition, brain MRI is performed.

Enrollment: 261 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All subjects who were treated at least once in BENEFIT study 304747 are eligible for inclusion in the BENEFIT 15 study

Exclusion criteria

• 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
• Suspected clinical instability or unpredictability of the clinical course during the study(e.g., due to previous surgery or acute stroke)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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261 participants in 2 patient groups

Experimental arm 15 years ago

Other group

Description:

This long term study does not imply current study medication. It looks at the status 15 years after the clinicial trial (BENEFIT)

Treatment:

Other: Brain MRI

Other: Blood sampling

Placebo arm, offered treatment at MS diagnosis or at Month 24

Other group

Description:

This long term study does not imply current study medication. It looks at the status 15 years after the clinicial trial (BENEFIT)

Treatment:

Other: Brain MRI

Other: Blood sampling