Scan-Rescan Sub-Study of MS PATHS

NCT04123353 | Completed

• 1 other identifier: 888MS004
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (9)

• Overall Reproducibility of Brain Volume

  Baseline up to Day 7

• Overall Reproducibility of Lesions

  Baseline up to Day 7

• Intrascanner Reproducibility of Brain Volume

  Baseline up to Day 7

• Intrascanner Reproducibility of Lesions

  Baseline up to Day 7

• Interscanner Reproducibility of Brain Volume

  Baseline up to Day 7

• Interscanner Reproducibility of Lesions

  Baseline up to Day 7

• Intra-class Correlation Coefficients (ICCs) Across Repeated Magnetic Resonance Imaging (MRI) for Brain Lesions

  Baseline up to Day 7

• Kappa Coefficients Across Expert Manual Segmentation for Brain Lesions

  Baseline up to Day 7

• Sensitivity and Specificity for Lesion Detection

  Baseline up to Day 7

Secondary Outcomes (1)

• Correlation Coefficients of Equation Parameters for Models to Map Brain Volume and Lesion Measurements between Scanners

  Baseline up to Day 7

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Potential participants will be participants with MS enrolled in Study 888MS001 who have varying levels of disease severity and symptom duration.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (3)

Research Site

Baltimore, Maryland, 21205, United States

Location

Research Site

New York, New York, 10016, United States

Location

Research Site

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: October 10, 2019
• Study Start: February 11, 2017
• Primary Completion: May 9, 2017
• Study Completion: May 9, 2017
• Last Updated: October 10, 2019

Record last verified: 2019-10

Locations

US (3)