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

Tracking Information

• First Submitted Date: December 15, 2016
• First Posted Date: December 19, 2016
• Last Update Posted Date: January 6, 2021
• Actual Study Start Date: December 12, 2017
• Estimated Primary Completion Date: December 15, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 15, 2016)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 17, 2017)

Development of models to calibrate brain volume measurements between centers, if necessary [ Time Frame: Up to 3 years ]

Measured by using MRI scans

• Original Secondary Outcome Measures (submitted: December 15, 2016): Development of models to calibrate brain volume measurements between centers, if necessary [ Time Frame: Up to 3 years ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: MS PATHS Normative Sub-Study
• 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)
• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples Without DNA

Description:

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

• 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).
• Condition: Healthy Volunteer
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: December 15, 2016): 200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 15, 2022
• Estimated Primary Completion Date: December 15, 2022 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany, Spain, United States

Administrative Information

• NCT Number: NCT02996084
• Other Study ID Numbers: 888MS005
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Biogen
• Study Sponsor: Biogen
• Collaborators: Not Provided

Investigators

• Study Director: Medical Director; Biogen

• PRS Account: Biogen
• Verification Date: January 2021