MS PATHS Normative Sub-Study

• ClinicalTrials.gov Identifier: NCT02996084
• Recruitment Status: Active, not recruiting
• First Posted: December 19, 2016
• Last Update Posted: January 6, 2021
• Sponsor: Biogen
• Information provided by (Responsible Party): Biogen

Study Description

Brief Summary:

The primary objective of this study is to determine the normative range of brain volume and brain volume change in healthy control (HC) participants whose age, race, and gender distribution is approximately matched to the age, race, and gender distribution of patients with Multiple Sclerosis (MS) enrolled in Study 888MS001. The secondary objective is to use the results of the primary endpoint to ensure consistency of brain volume measurements across MS PATHS centers.

Condition or disease
Healthy Volunteer

Study Design

• Study Type: Observational
• Estimated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Longitudinal Brain Volume Change (and Correlates) in Healthy Control Subjects: A Normative Sub-Study of Multiple Sclerosis Partners Advancing Technology and Health Solutions (MS PATHS)
• Actual Study Start Date: December 12, 2017
• Estimated Primary Completion Date: December 15, 2022
• Estimated Study Completion Date: December 15, 2022

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Brain volume [ Time Frame: Every 12 months up to 3 years ]
   Measured by using magnetic resonance imaging (MRI) scans
2. Brain volume change [ Time Frame: Every 12 months up to 3 years ]
   Measured by using MRI scans

Secondary Outcome Measures :

1. Development of models to calibrate brain volume measurements between centers, if necessary [ Time Frame: Up to 3 years ]
   Measured by using MRI scans

Biospecimen Retention:   Samples Without DNA

Ribonucleic acid (RNA), serum, and whole blood biomarker samples

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Healthy control (HC) participants enrolled at each institution will be carefully selected to result in a group whose age, race, and gender distribution is approximately matched to the age, race, and gender distribution of patients with MS enrolled in MS PATHS at that center. Patients enrolled in MS PATHS at each center will be encouraged to enlist a friend or family member to participate in the study as an HC. Subsequently, on approximately quarterly review of participant participation, particular demographic groups will be targeted for recruitment, if needed, in order for the age, race, and gender distribution of a center's HC sample to be similar to their MS PATHS participant sample (within the study age range).

Criteria

Key Inclusion Criteria

• Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local participant privacy regulations.

Key Exclusion Criteria

• History of human immunodeficiency virus.
• Confirmed or suspected pregnancy.
• Diagnosis of migraine requiring medication or any other participant-reported diagnosis of a neurological disease or condition (e.g., stroke, transient ischemic attack, epilepsy, brain infection, brain surgery, prior head injury or concussion, or brain tumor).
• Any participant-reported diagnosis of an autoimmune disorder (e.g., rheumatoid arthritis, Sjögren's syndrome, scleroderma, or systemic lupus erythematosus).
• Standard MRI exclusion criteria, including claustrophobia, inability to lay still in the magnet (e.g., tremor), or any type of implanted metal in the body that would be affected by the strong magnetic field.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Contacts and Locations

Locations

United States, Maryland

Johns Hopkins University

Baltimore, Maryland, United States, 21287

United States, Missouri

Washington University

Saint Louis, Missouri, United States, 63110

United States, New York

University of Rochester Medical Center

Rochester, New York, United States, 14642

United States, Ohio

The Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

Germany

University Hospital Carl Gustav Carus Dresden

Dresden, Germany

Spain

Multiple Sclerosis Centre of Catalonia (Cemcat) Vall d'Hebron Hospital

Barcelona, Spain

Sponsors and Collaborators

Biogen

Investigators

• Study Director: Medical Director; Biogen

More Information

• Responsible Party: Biogen
• ClinicalTrials.gov Identifier: NCT02996084
• Other Study ID Numbers: 888MS005
• First Posted: December 19, 2016
• Last Update Posted: January 6, 2021
• Last Verified: January 2021

Keywords provided by Biogen:

Imaging research