| Primary | Number of Participants Developing a New MS Relapse and/or MRI Brain Lesion Over the Course of the Study Duration | The outcome is the proportion of participants in each group developing a new MS relapse and/or MRI brain lesion over the course of the study duration. Count of Participants with either a new MS relapse and/or a new brain MRI lesion is reported. | | Posted | | Count of Participants | | Participants | | 18-24 months, based on time of enrollment | | | | ID | Title | Description |
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| OG000 | Drug Continuation Arm | Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. Standard of Care: Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. | | OG001 | Drug Discontinuation Arm | Participants who will discontinue their Disease Modifying Therapies (DMTs). No other changes to their treatment occur. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. Discontinuation of disease modifying therapy: Participants who will discontinue their current MS drug. No other changes to their treatment occur. |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| We tested the null hypothesis of inferiority with the proportion of disease events (i.e., new MS relapse and/or MRI brain lesion) for the drug discontinuation group being 8% greater than the proportion for the drug continuation group under the alternative that the two rates are equal. | Exact binomial test | Exact binomial test for difference in two proportions | 0.521 | | Difference in proportion | 0.0753 | | | 2-Sided | 95 | 0.0063 | 0.1500 | | | | | Non-Inferiority | We performed a non-inferiority test for the proportions of the drug continuation and drug discontinuation arms experiencing a new MS relapse and/or MRI Brain Lesion over the course of the study duration. The non-inferiority margin used was 8%. |
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| Secondary | Number With Disability Progression Confirmed at 6 Months Using the Expanded Disability Status Scale (EDSS) | The EDSS is a neurological examination performed by a blinded rater. This assessment is collected at each study visit. Increase in the EDSS score shows disease activity or progression, and must be observed six months later to be confirmed. Whether a confirmed change is significant depends on the subject's EDSS at baseline: for those with a baseline EDSS of 5.5 points or fewer, the increase must be at least one point to be significant; for those with a baseline EDSS of 6.0 points or greater, a change of at least 0.5 points is considered significant. We will calculate the percentage in each group of those who had a significant change at anytime during the follow-up period, which was then confirmed at 6 months later. | Three subjects (2 in drug continuation arm and 1 in drug discontinuation arm) did not have a baseline EDSS recorded, so change in EDSS could not be assessed. | Posted | | Count of Participants | | Participants | | Baseline, then every 6 months for up to a maximum of 24 months, based on time of enrollment. | | | | ID | Title | Description |
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| OG000 | Drug Continuation Arm | Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. Standard of Care: Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. | |
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| Secondary | Change in Neuro-QoL (Quality of Life) Short Form Scores -- Upper Extremity Function | The Neuro-QOL Adult PRO short form measures are collected to evaluate self-reported overall quality of life and functioning in patients with a variety of neurological conditions including MS. The Neuro-Qol short form scales consist of 5-9 single scale item scales. Raw scores are then converted to a standardized score with mean 50 and standard deviation 10. The Neuro-QoL short forms used in this study with higher scores representing better outcomes are: Upper Extremity Function, Lower Extremity Function, Cognitive -- General Concerns, Cognitive -- Executive Function, Communication, Positive Affect and Well-Being, Satisfaction with Social Roles and Activities, and Ability to Participate in Social Roles and Activities. The short forms used with lower scores representing better outcomes are: Fatigue, Sleep Disturbance, Anxiety, Depression, and Emotional-Behavioral Dyscontrol. | Subjects missing Neuro-QOL at either baseline or at Month 18-24 were excluded from this analysis | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 18-24 Months, based on time of enrollment | | | | ID | Title | Description |
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| OG000 | Drug Continuation Arm | Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. Standard of Care: Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. |
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| Secondary | Change in Neuro-QoL (Quality of Life) Short Form Scores -- Lower Extremity Function | The Neuro-QOL Adult PRO short form measures are collected to evaluate self-reported overall quality of life and functioning in patients with a variety of neurological conditions including MS. The Neuro-Qol short form scales consist of 5-9 single scale item scales. Raw scores are then converted to a standardized score with mean 50 and standard deviation 10. The Neuro-QoL short forms used in this study with higher scores representing better outcomes are: Upper Extremity Function, Lower Extremity Function, Cognitive -- General Concerns, Cognitive -- Executive Function, Communication, Positive Affect and Well-Being, Satisfaction with Social Roles and Activities, and Ability to Participate in Social Roles and Activities. The short forms used with lower scores representing better outcomes are: Fatigue, Sleep Disturbance, Anxiety, Depression, and Emotional-Behavioral Dyscontrol. | Subjects missing Neuro-QOL at either baseline or at Month 18-24 were excluded from this analysis | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 18-24 Months, based on time of enrollment | | | | ID | Title | Description |
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| OG000 | Drug Continuation Arm | Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. Standard of Care: Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. |
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| Secondary | Change in Neuro-QoL (Quality of Life) Short Form Scores -- Fatigue | The Neuro-QOL Adult PRO short form measures are collected to evaluate self-reported overall quality of life and functioning in patients with a variety of neurological conditions including MS. The Neuro-Qol short form scales consist of 5-9 single scale item scales. Raw scores are then converted to a standardized score with mean 50 and standard deviation 10. The Neuro-QoL short forms used in this study with higher scores representing better outcomes are: Upper Extremity Function, Lower Extremity Function, Cognitive -- General Concerns, Cognitive -- Executive Function, Communication, Positive Affect and Well-Being, Satisfaction with Social Roles and Activities, and Ability to Participate in Social Roles and Activities. The short forms used with lower scores representing better outcomes are: Fatigue, Sleep Disturbance, Anxiety, Depression, and Emotional-Behavioral Dyscontrol. | Subjects missing Neuro-QOL at either baseline or at Month 18-24 were excluded from this analysis | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 18-24 Months, based on time of enrollment | | | | ID | Title | Description |
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| OG000 | Drug Continuation Arm | Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. Standard of Care: Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. |
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| Secondary | Change in Neuro-QoL (Quality of Life) Short Form Scores -- Sleep Disturbance | The Neuro-QOL Adult PRO short form measures are collected to evaluate self-reported overall quality of life and functioning in patients with a variety of neurological conditions including MS. The Neuro-Qol short form scales consist of 5-9 single scale item scales. Raw scores are then converted to a standardized score with mean 50 and standard deviation 10. The Neuro-QoL short forms used in this study with higher scores representing better outcomes are: Upper Extremity Function, Lower Extremity Function, Cognitive -- General Concerns, Cognitive -- Executive Function, Communication, Positive Affect and Well-Being, Satisfaction with Social Roles and Activities, and Ability to Participate in Social Roles and Activities. The short forms used with lower scores representing better outcomes are: Fatigue, Sleep Disturbance, Anxiety, Depression, and Emotional-Behavioral Dyscontrol. | Subjects missing Neuro-QOL at either baseline or at Month 18-24 were excluded from this analysis | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 18-24 Months, based on time of enrollment | | | | ID | Title | Description |
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| OG000 | Drug Continuation Arm | Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. Standard of Care: Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. |
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| Secondary | Change in Neuro-QoL (Quality of Life) Short Form Scores -- General Concerns | The Neuro-QOL Adult PRO short form measures are collected to evaluate self-reported overall quality of life and functioning in patients with a variety of neurological conditions including MS. The Neuro-Qol short form scales consist of 5-9 single scale item scales. Raw scores are then converted to a standardized score with mean 50 and standard deviation 10. The Neuro-QoL short forms used in this study with higher scores representing better outcomes are: Upper Extremity Function, Lower Extremity Function, Cognitive -- General Concerns, Cognitive -- Executive Function, Communication, Positive Affect and Well-Being, Satisfaction with Social Roles and Activities, and Ability to Participate in Social Roles and Activities. The short forms used with lower scores representing better outcomes are: Fatigue, Sleep Disturbance, Anxiety, Depression, and Emotional-Behavioral Dyscontrol. | Subjects missing Neuro-QOL at either baseline or at Month 18-24 were excluded from this analysis | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 18-24 Months, based on time of enrollment | | | | ID | Title | Description |
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| OG000 | Drug Continuation Arm | Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. Standard of Care: Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. |
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| Secondary | Change in Neuro-QoL (Quality of Life) Short Form Scores -- Executive Function | The Neuro-QOL Adult PRO short form measures are collected to evaluate self-reported overall quality of life and functioning in patients with a variety of neurological conditions including MS. The Neuro-Qol short form scales consist of 5-9 single scale item scales. Raw scores are then converted to a standardized score with mean 50 and standard deviation 10. The Neuro-QoL short forms used in this study with higher scores representing better outcomes are: Upper Extremity Function, Lower Extremity Function, Cognitive -- General Concerns, Cognitive -- Executive Function, Communication, Positive Affect and Well-Being, Satisfaction with Social Roles and Activities, and Ability to Participate in Social Roles and Activities. The short forms used with lower scores representing better outcomes are: Fatigue, Sleep Disturbance, Anxiety, Depression, and Emotional-Behavioral Dyscontrol. | Subjects missing Neuro-QOL at either baseline or at Month 18-24 were excluded from this analysis | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 18-24 Months, based on time of enrollment | | | | ID | Title | Description |
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| OG000 | Drug Continuation Arm | Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. Standard of Care: Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. |
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| Secondary | Change in Neuro-QoL (Quality of Life) Short Form Scores -- Communication | The Neuro-QOL Adult PRO short form measures are collected to evaluate self-reported overall quality of life and functioning in patients with a variety of neurological conditions including MS. The Neuro-Qol short form scales consist of 5-9 single scale item scales. Raw scores are then converted to a standardized score with mean 50 and standard deviation 10. The Neuro-QoL short forms used in this study with higher scores representing better outcomes are: Upper Extremity Function, Lower Extremity Function, Cognitive -- General Concerns, Cognitive -- Executive Function, Communication, Positive Affect and Well-Being, Satisfaction with Social Roles and Activities, and Ability to Participate in Social Roles and Activities. The short forms used with lower scores representing better outcomes are: Fatigue, Sleep Disturbance, Anxiety, Depression, and Emotional-Behavioral Dyscontrol. | Subjects missing Neuro-QOL at either baseline or at Month 18-24 were excluded from this analysis | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 18-24 Months, based on time of enrollment | | | | ID | Title | Description |
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| OG000 | Drug Continuation Arm | Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. Standard of Care: Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. |
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| Secondary | Change in Neuro-QoL (Quality of Life) Short Form Scores -- Anxiety | The Neuro-QOL Adult PRO short form measures are collected to evaluate self-reported overall quality of life and functioning in patients with a variety of neurological conditions including MS. The Neuro-Qol short form scales consist of 5-9 single scale item scales. Raw scores are then converted to a standardized score with mean 50 and standard deviation 10. The Neuro-QoL short forms used in this study with higher scores representing better outcomes are: Upper Extremity Function, Lower Extremity Function, Cognitive -- General Concerns, Cognitive -- Executive Function, Communication, Positive Affect and Well-Being, Satisfaction with Social Roles and Activities, and Ability to Participate in Social Roles and Activities. The short forms used with lower scores representing better outcomes are: Fatigue, Sleep Disturbance, Anxiety, Depression, and Emotional-Behavioral Dyscontrol. | Subjects missing Neuro-QOL at either baseline or at Month 18-24 were excluded from this analysis | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 18-24 Months, based on time of enrollment | | | | ID | Title | Description |
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| OG000 | Drug Continuation Arm | Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. Standard of Care: Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. |
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| Secondary | Change in Neuro-QoL (Quality of Life) Short Form Scores -- Depression | The Neuro-QOL Adult PRO short form measures are collected to evaluate self-reported overall quality of life and functioning in patients with a variety of neurological conditions including MS. The Neuro-Qol short form scales consist of 5-9 single scale item scales. Raw scores are then converted to a standardized score with mean 50 and standard deviation 10. The Neuro-QoL short forms used in this study with higher scores representing better outcomes are: Upper Extremity Function, Lower Extremity Function, Cognitive -- General Concerns, Cognitive -- Executive Function, Communication, Positive Affect and Well-Being, Satisfaction with Social Roles and Activities, and Ability to Participate in Social Roles and Activities. The short forms used with lower scores representing better outcomes are: Fatigue, Sleep Disturbance, Anxiety, Depression, and Emotional-Behavioral Dyscontrol. | Subjects missing Neuro-QOL at either baseline or at Month 18-24 were excluded from this analysis | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 18-24 Months, based on time of enrollment | | | | ID | Title | Description |
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| OG000 | Drug Continuation Arm | Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. Standard of Care: Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. |
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| Secondary | Change in Neuro-QoL (Quality of Life) Short Form Scores -- Positive Affect and Well-Being | The Neuro-QOL Adult PRO short form measures are collected to evaluate self-reported overall quality of life and functioning in patients with a variety of neurological conditions including MS. The Neuro-Qol short form scales consist of 5-9 single scale item scales. Raw scores are then converted to a standardized score with mean 50 and standard deviation 10. The Neuro-QoL short forms used in this study with higher scores representing better outcomes are: Upper Extremity Function, Lower Extremity Function, Cognitive -- General Concerns, Cognitive -- Executive Function, Communication, Positive Affect and Well-Being, Satisfaction with Social Roles and Activities, and Ability to Participate in Social Roles and Activities. The short forms used with lower scores representing better outcomes are: Fatigue, Sleep Disturbance, Anxiety, Depression, and Emotional-Behavioral Dyscontrol. | Subjects missing Neuro-QOL at either baseline or at Month 18-24 were excluded from this analysis | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 18-24 Months, based on time of enrollment | | | | ID | Title | Description |
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| OG000 | Drug Continuation Arm | Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. Standard of Care: Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. |
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| Secondary | Change in Neuro-QoL (Quality of Life) Short Form Scores -- Emotional-Behavioral Dyscontrol | The Neuro-QOL Adult PRO short form measures are collected to evaluate self-reported overall quality of life and functioning in patients with a variety of neurological conditions including MS. The Neuro-Qol short form scales consist of 5-9 single scale item scales. Raw scores are then converted to a standardized score with mean 50 and standard deviation 10. The Neuro-QoL short forms used in this study with higher scores representing better outcomes are: Upper Extremity Function, Lower Extremity Function, Cognitive -- General Concerns, Cognitive -- Executive Function, Communication, Positive Affect and Well-Being, Satisfaction with Social Roles and Activities, and Ability to Participate in Social Roles and Activities. The short forms used with lower scores representing better outcomes are: Fatigue, Sleep Disturbance, Anxiety, Depression, and Emotional-Behavioral Dyscontrol. | Subjects missing Neuro-QOL at either baseline or at Month 18-24 were excluded from this analysis | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 18-24 Months, based on time of enrollment | | | | ID | Title | Description |
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| OG000 | Drug Continuation Arm | Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. Standard of Care: Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. |
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| Secondary | Change in Neuro-QoL (Quality of Life) Short Form Scores -- Satisfaction With Social Roles and Activities | The Neuro-QOL Adult PRO short form measures are collected to evaluate self-reported overall quality of life and functioning in patients with a variety of neurological conditions including MS. The Neuro-Qol short form scales consist of 5-9 single scale item scales. Raw scores are then converted to a standardized score with mean 50 and standard deviation 10. The Neuro-QoL short forms used in this study with higher scores representing better outcomes are: Upper Extremity Function, Lower Extremity Function, Cognitive -- General Concerns, Cognitive -- Executive Function, Communication, Positive Affect and Well-Being, Satisfaction with Social Roles and Activities, and Ability to Participate in Social Roles and Activities. The short forms used with lower scores representing better outcomes are: Fatigue, Sleep Disturbance, Anxiety, Depression, and Emotional-Behavioral Dyscontrol. | Subjects missing Neuro-QOL at either baseline or at Month 18-24 were excluded from this analysis | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 18-24 Months, based on time of enrollment | | | | ID | Title | Description |
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| OG000 | Drug Continuation Arm | Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. Standard of Care: Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. |
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| Secondary | Change in Neuro-QoL (Quality of Life) Short Form Scores -- Ability to Participate in Social Roles and Activities | The Neuro-QOL Adult PRO short form measures are collected to evaluate self-reported overall quality of life and functioning in patients with a variety of neurological conditions including MS. The Neuro-Qol short form scales consist of 5-9 single scale item scales. Raw scores are then converted to a standardized score with mean 50 and standard deviation 10. The Neuro-QoL short forms used in this study with higher scores representing better outcomes are: Upper Extremity Function, Lower Extremity Function, Cognitive -- General Concerns, Cognitive -- Executive Function, Communication, Positive Affect and Well-Being, Satisfaction with Social Roles and Activities, and Ability to Participate in Social Roles and Activities. The short forms used with lower scores representing better outcomes are: Fatigue, Sleep Disturbance, Anxiety, Depression, and Emotional-Behavioral Dyscontrol. | Subjects missing Neuro-QOL at either baseline or at Month 18-24 were excluded from this analysis | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 18-24 Months, based on time of enrollment | | | | ID | Title | Description |
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| OG000 | Drug Continuation Arm | Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. Standard of Care: Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. |
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| Secondary | Change in SymptoMScreen Composite Score (SymptoMScreen - Overall Symptom Severity). | SymptoMScreen will be collected to assess overall symptom severity. Participants self-report across multiple neurological domains (mobility, hand function, spasticity, pain, sensory, bladder, fatigue, vision, dizziness, cognition, depression, and anxiety). This scale is a single page, validated measure that allows for quick assessment of multiple symptoms. Single item scores are rated as 0-6 with higher numbers representing increased limitations and symptom severity. Composite score is calculated by summing the single item scores with total score ranges from 0 to 72. | Subjects missing SymptoMScreen at either baseline or at Month 18-24 were excluded from this analysis | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, then every 6 months for up to a maximum of 24 months, based on time of enrollment. The change between baseline and Month 18-24 is reported. | | | | ID | Title | Description |
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| OG000 | Drug Continuation Arm | Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. Standard of Care: Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. | | OG001 | Drug Discontinuation Arm | |
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| Secondary | Change in Patient-Determined Disease Steps (PDDS - Disability). | Patient-Determined Disease Steps will be collected to assess changes in disability from the patient's perspective. This outcome measure is a single question. The scores range from 0 to 8, and a participant with a low score has less perceived disability than a participant with a higher score. | Subjects missing PDDS at either baseline or at Month 18-24 were excluded from this analysis | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, then every 6 months for up to a maximum of 24 months, based on time of enrollment. The change between baseline and Month 18-24 is reported. | | | | ID | Title | Description |
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| OG000 | Drug Continuation Arm | Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. Standard of Care: Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. | | OG001 | Drug Discontinuation Arm | Participants who will discontinue their Disease Modifying Therapies (DMTs). No other changes to their treatment occur. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. Discontinuation of disease modifying therapy: Participants who will discontinue their current MS drug. No other changes to their treatment occur. |
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| Secondary | Change in Symbol Digit Modalities Test (SDMT - Cognition). | The SDMT measures patient attention, concentration, and speed of information processing and has been validated for discriminating patients from controls. Possible scores range from 0 to 110, with higher scores indicating a better outcome. | Subjects missing SDMT at either baseline or at Month 18-24 were excluded from this analysis | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, then every 6 months for up to a maximum of 24 months, based on time of enrollment. The change between baseline and Month 18-24 is reported. | | | | ID | Title | Description |
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| OG000 | Drug Continuation Arm | Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. Standard of Care: Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. | | OG001 | Drug Discontinuation Arm | Participants who will discontinue their Disease Modifying Therapies (DMTs). No other changes to their treatment occur. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. Discontinuation of disease modifying therapy: Participants who will discontinue their current MS drug. No other changes to their treatment occur. |
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| Secondary | Evaluation of the Patient's Quality of Life Using the MSIS-29 Scale -- Physical Impact | The Multiple Sclerosis Impact Scale (MSIS-29) will be collected to assess changes in quality of life from the patient's perspective. The MSIS has 29 questions. Each question asks the participant to rank how impacted they are in a certain aspect of their life. The options are 1 through 4. 1 indicates not at all impacted while 4 indicates extremely impacted. The lower the final score, the less impacted the participant is overall. Scores on the physical impact scale range from 20-80 and from 9-36 on the psychological impact scale. We will compare the proportion in each group who have had a change of 7.5 points or more (considered a clinically meaningful change). | Subjects missing MSIS-29 at either baseline or at Month 18-24 were excluded from this analysis | Posted | | Count of Participants | | Participants | | Baseline, then every 6 months for up to a maximum of 24 months, based on time of enrollment. The change between baseline and Month 18-24 is reported. | | | | ID | Title | Description |
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| OG000 | Drug Continuation Arm | Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. Standard of Care: Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. | | OG001 |
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| Secondary | Evaluation of the Patient's Quality of Life Using the MSIS-29 Scale -- Psychological Impact | The Multiple Sclerosis Impact Scale (MSIS-29) will be collected to assess changes in quality of life from the patient's perspective. The MSIS has 29 questions. Each question asks the participant to rank how impacted they are in a certain aspect of their life. The options are 1 through 4. 1 indicates not at all impacted while 4 indicates extremely impacted. The lower the final score, the less impacted the participant is overall. Scores on the physical impact scale range from 20-80 and from 9-36 on the psychological impact scale. We will compare the proportion in each group who have had a change of 7.5 points or more (considered a clinically meaningful change). | Subjects missing MSIS-29 at either baseline or at Month 18-24 were excluded from this analysis | Posted | | Count of Participants | | Participants | | Baseline, then every 6 months for up to a maximum of 24 months, based on time of enrollment. The change between baseline and Month 18-24 is reported. | | | | ID | Title | Description |
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| OG000 | Drug Continuation Arm | Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. Standard of Care: Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. | | OG001 |
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| Other Pre-specified | Total Number of New T2 Lesions on MRI | MRIs will be reviewed to determine the total number of new T2 lesions that develop for each subject over the course of the study. Lesion counts will be performed by the central MRI facility. | | Posted | | Median | Full Range | lesions | | Baseline, then every 6 months for 2 years with one exception at 18 months. | | | | ID | Title | Description |
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| OG000 | Drug Continuation Arm | Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. Standard of Care: Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. | | OG001 | Drug Discontinuation Arm | Participants who will discontinue their Disease Modifying Therapies (DMTs). No other changes to their treatment occur. DMTs include ~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease. Discontinuation of disease modifying therapy: Participants who will discontinue their current MS drug. No other changes to their treatment occur. |
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