Scan-Rescan Sub-Study of MS PATHS

Biogen

Status: Completed

Conditions: Multiple Sclerosis

Study type: Observational

Funder types: Industry

Identifiers

NCT04123353

888MS004

Details and patient eligibility

About

The primary objective of this sub-study is to calculate the reproducibility and other technical performance measures of various magnetic resonance imaging (MRI) image analysis algorithms in order to assess their suitability for detecting changes due to multiple sclerosis (MS) in a real-world setting in participants with MS. The secondary objective of this sub-study is to use the primary endpoint results to calibrate measurements across scanners within each MS PATHS center.

Enrollment: 30 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Participants (or participant's legal representative) has the ability to understand the purpose and risks of the sub-study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and l local participant privacy regulations.
• Diagnosis of relapse-onset MS (relapsing-remitting or secondary progressive).
• First MS symptom within the past 1 to 30 years.

Key Exclusion Criteria:

• Initiation of any MS disease-modifying treatment within 4 weeks prior to Visit 1.
• Steroid treatment or suspected MS relapse within 6 weeks prior to Visit 1.

Note: Other protocol specified inclusion and exclusion criteria may apply.