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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Coefficients of Equation Parameters for Models to Map Brain Volume and Lesion Measurements between Scanners | Baseline up to Day 7 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol specified inclusion and exclusion criteria may apply.
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Potential participants will be participants with MS enrolled in Study 888MS001 who have varying levels of disease severity and symptom duration.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Baltimore | Maryland | 21205 | United States | ||
| Research Site |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| New York |
| New York |
| 10016 |
| United States |
| Research Site | Cleveland | Ohio | 44195 | United States |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |