Trial Outcomes & Findings for Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS): Extension of the DISCOMS Study (NCT NCT04754542)
NCT ID: NCT04754542
Last Updated: 2024-09-25
Results Overview
As inflammatory disease activity may be manifested clinically as a relapse, or radiographically as a new MRI lesion, we have chosen a combined primary outcome measure.
COMPLETED
76 participants
Month 36 visit. The Month 36 visit was the extension study's only visit, which occurred 36 months after randomization in the original DISCOMS study (NCT03073603).
2024-09-25
Participant Flow
Study population is limited to subjects that are currently participating in or have completed the DISCOMS trial (NCT# 03073603). Only subjects that remained in their original treatment arm throughout the trial as well as those that remained in their treatment arm after their participation was completed will qualify. Participants in the DISCOMS trial that experienced a relapse during the study will not qualify for the extension.
Participant milestones
| Measure |
Continuation
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to continue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
Discontinuation
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to discontinue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
45
|
|
Overall Study
COMPLETED
|
30
|
44
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Continuation
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to continue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
Discontinuation
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to discontinue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
|---|---|---|
|
Overall Study
Subject enrolled in error; did not meet eligibility criteria
|
1
|
1
|
Baseline Characteristics
Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS): Extension of the DISCOMS Study
Baseline characteristics by cohort
| Measure |
Discontinuation
n=44 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to discontinue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
Continuation
n=30 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to continue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.1 years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
61 years
STANDARD_DEVIATION 4.4 • n=7 Participants
|
62.2 years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
41 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=5 Participants
|
30 participants
n=7 Participants
|
76 participants
n=5 Participants
|
|
MS Phenotype
Relapsing-Remitting
|
40 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
MS Phenotype
Secondary Progressive
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Time since first onset of symptoms related to MS
|
23.7 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
17.1 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
21.0 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Time since last documented relapse
|
14.5 years
STANDARD_DEVIATION 6 • n=5 Participants
|
11.5 years
STANDARD_DEVIATION 5.1 • n=7 Participants
|
13.3 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: Month 36 visit. The Month 36 visit was the extension study's only visit, which occurred 36 months after randomization in the original DISCOMS study (NCT03073603).As inflammatory disease activity may be manifested clinically as a relapse, or radiographically as a new MRI lesion, we have chosen a combined primary outcome measure.
Outcome measures
| Measure |
Discontinuation
n=44 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to discontinue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
Continuation
n=30 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to continue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
|---|---|---|
|
Number of Participants Off Drug That Have New Inflammatory Disease Compared to Those on Drug.
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline of the original DISCOMS study (NCT03073603) and Month 36. The Month 36 visit was the extension study's only visit, which occurred 36 months after randomization in the original DISCOMS study.The Expanded Disability Status Scale (EDSS) is a commonly used assessment that allows clinicians to objectively measure changes in a patient's symptoms by using unbiased raters. This assessment will be collected at all time-points and will be used to measure changes in patients' symptoms over the course of the study and will be used to help define 'relapse', i.e. will require a change on examination. Possible scores range from 0 to 10, with higher scores indicating a worse outcome (i.e. more severe disability) The change between baseline of the original DISCOMS study (NCT03073603) and Month 36 is reported.
Outcome measures
| Measure |
Discontinuation
n=28 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to discontinue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
Continuation
n=44 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to continue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
|---|---|---|
|
Compare the Change in Disability Using the EDSS Over the Duration of the Trial in Those Who Were Able to Maintain Their Treatment Assignment Without Inflammatory Activity.
|
0 score on a scale
Standard Deviation 0.82
|
0.10 score on a scale
Standard Deviation 0.94
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline of the original DISCOMS study (NCT03073603) and Month 36. The Month 36 visit was the extension study's only visit, which occurred 36 months after randomization in the original DISCOMS study.Population: Subjects missing Neuro-QoL at either DISCOMS baseline or at Month 36 were excluded from this analysis.
The Neuro-QOL Adult PRO short form measures are self-reported measures of overall quality of life and functioning. 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. The change between baseline of the original DISCOMS study (NCT03073603) and Month 36 is reported.
Outcome measures
| Measure |
Discontinuation
n=29 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to discontinue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
Continuation
n=43 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to continue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
|---|---|---|
|
Change in Patient Reported Outcomes (PROs) - NeuroQoL Short Form Scores -- Upper Extremity Function
|
0.2 units on a scale
Standard Deviation 5.1
|
0.1 units on a scale
Standard Deviation 4.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline of the original DISCOMS study (NCT03073603) and Month 36. The Month 36 visit was the extension study's only visit, which occurred 36 months after randomization in the original DISCOMS study.Population: Subjects missing Neuro-QoL at either DISCOMS baseline or at Month 36 were excluded from this analysis.
The Neuro-QOL Adult PRO short form measures are self-reported measures of overall quality of life and functioning. 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. The change between baseline of the original DISCOMS study (NCT03073603) and Month 36 is reported.
Outcome measures
| Measure |
Discontinuation
n=29 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to discontinue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
Continuation
n=43 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to continue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
|---|---|---|
|
Change in Patient Reported Outcomes (PROs) - NeuroQoL Short Form Scores -- Lower Extremity Function
|
0.4 units on a scale
Standard Deviation 7
|
-0.6 units on a scale
Standard Deviation 5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline of the original DISCOMS study (NCT03073603) and Month 36. The Month 36 visit was the extension study's only visit, which occurred 36 months after randomization in the original DISCOMS study.Population: Subjects missing Neuro-QoL at either DISCOMS baseline or at Month 36 were excluded from this analysis.
The Neuro-QOL Adult PRO short form measures are self-reported measures of overall quality of life and functioning. 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. The change between baseline of the original DISCOMS study (NCT03073603) and Month 36 is reported.
Outcome measures
| Measure |
Discontinuation
n=29 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to discontinue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
Continuation
n=43 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to continue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
|---|---|---|
|
Change in Patient Reported Outcomes (PROs) - NeuroQoL Short Form Scores -- Fatigue
|
-0.2 units on a scale
Standard Deviation 5.7
|
0.6 units on a scale
Standard Deviation 5.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline of the original DISCOMS study (NCT03073603) and Month 36. The Month 36 visit was the extension study's only visit, which occurred 36 months after randomization in the original DISCOMS study.Population: Subjects missing Neuro-QoL at either DISCOMS baseline or at Month 36 were excluded from this analysis.
The Neuro-QOL Adult PRO short form measures are self-reported measures of overall quality of life and functioning. 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. The change between baseline of the original DISCOMS study (NCT03073603) and Month 36 is reported.
Outcome measures
| Measure |
Discontinuation
n=29 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to discontinue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
Continuation
n=43 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to continue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
|---|---|---|
|
Change in Patient Reported Outcomes (PROs) - NeuroQoL Short Form Scores -- Sleep Disturbance
|
-0.5 units on a scale
Standard Deviation 5.8
|
0.6 units on a scale
Standard Deviation 5.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline of the original DISCOMS study (NCT03073603) and Month 36. The Month 36 visit was the extension study's only visit, which occurred 36 months after randomization in the original DISCOMS study.Population: Subjects missing Neuro-QoL at either DISCOMS baseline or at Month 36 were excluded from this analysis.
The Neuro-QOL Adult PRO short form measures are self-reported measures of overall quality of life and functioning. 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. The change between baseline of the original DISCOMS study (NCT03073603) and Month 36 is reported.
Outcome measures
| Measure |
Discontinuation
n=29 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to discontinue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
Continuation
n=43 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to continue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
|---|---|---|
|
Change in Patient Reported Outcomes (PROs) - NeuroQoL Short Form Scores -- General Concerns
|
0.5 units on a scale
Standard Deviation 3.7
|
2.3 units on a scale
Standard Deviation 6.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline of the original DISCOMS study (NCT03073603) and Month 36. The Month 36 visit was the extension study's only visit, which occurred 36 months after randomization in the original DISCOMS study.Population: Subjects missing Neuro-QoL at either DISCOMS baseline or at Month 36 were excluded from this analysis.
The Neuro-QOL Adult PRO short form measures are self-reported measures of overall quality of life and functioning. 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. The change between baseline of the original DISCOMS study (NCT03073603) and Month 36 is reported.
Outcome measures
| Measure |
Discontinuation
n=29 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to discontinue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
Continuation
n=43 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to continue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
|---|---|---|
|
Change in Patient Reported Outcomes (PROs) - NeuroQoL Short Form Scores -- Executive Function
|
1 units on a scale
Standard Deviation 5.8
|
-0.2 units on a scale
Standard Deviation 6.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline of the original DISCOMS study (NCT03073603) and Month 36. The Month 36 visit was the extension study's only visit, which occurred 36 months after randomization in the original DISCOMS study.Population: Subjects missing Neuro-QoL at either DISCOMS baseline or at Month 36 were excluded from this analysis.
The Neuro-QOL Adult PRO short form measures are self-reported measures of overall quality of life and functioning. 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. The change between baseline of the original DISCOMS study (NCT03073603) and Month 36 is reported.
Outcome measures
| Measure |
Discontinuation
n=28 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to discontinue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
Continuation
n=43 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to continue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
|---|---|---|
|
Change in Patient Reported Outcomes (PROs) - NeuroQoL Short Form Scores -- Communication
|
-0.1 units on a scale
Standard Deviation 2.1
|
-0.1 units on a scale
Standard Deviation 2.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline of the original DISCOMS study (NCT03073603) and Month 36. The Month 36 visit was the extension study's only visit, which occurred 36 months after randomization in the original DISCOMS study.Population: Subjects missing Neuro-QoL at either DISCOMS baseline or at Month 36 were excluded from this analysis.
The Neuro-QOL Adult PRO short form measures are self-reported measures of overall quality of life and functioning. 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. The change between baseline of the original DISCOMS study (NCT03073603) and Month 36 is reported.
Outcome measures
| Measure |
Discontinuation
n=29 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to discontinue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
Continuation
n=43 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to continue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
|---|---|---|
|
Change in Patient Reported Outcomes (PROs) - NeuroQoL Short Form Scores -- Anxiety
|
-0.2 units on a scale
Standard Deviation 4.8
|
1.3 units on a scale
Standard Deviation 7.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline of the original DISCOMS study (NCT03073603) and Month 36. The Month 36 visit was the extension study's only visit, which occurred 36 months after randomization in the original DISCOMS study.Population: Subjects missing Neuro-QoL at either DISCOMS baseline or at Month 36 were excluded from this analysis.
The Neuro-QOL Adult PRO short form measures are self-reported measures of overall quality of life and functioning. 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. The change between baseline of the original DISCOMS study (NCT03073603) and Month 36 is reported.
Outcome measures
| Measure |
Discontinuation
n=29 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to discontinue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
Continuation
n=43 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to continue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
|---|---|---|
|
Change in Patient Reported Outcomes (PROs) - NeuroQoL Short Form Scores -- Depression
|
-1.2 units on a scale
Standard Deviation 5.2
|
1.3 units on a scale
Standard Deviation 5.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline of the original DISCOMS study (NCT03073603) and Month 36. The Month 36 visit was the extension study's only visit, which occurred 36 months after randomization in the original DISCOMS study.Population: Subjects missing Neuro-QoL at either DISCOMS baseline or at Month 36 were excluded from this analysis.
The Neuro-QOL Adult PRO short form measures are self-reported measures of overall quality of life and functioning. 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. The change between baseline of the original DISCOMS study (NCT03073603) and Month 36 is reported.
Outcome measures
| Measure |
Discontinuation
n=29 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to discontinue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
Continuation
n=43 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to continue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
|---|---|---|
|
Change in Patient Reported Outcomes (PROs) - NeuroQoL Short Form Scores -- Positive Affect and Well-Being
|
2.5 units on a scale
Standard Deviation 6.4
|
-0.8 units on a scale
Standard Deviation 6.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline of the original DISCOMS study (NCT03073603) and Month 36. The Month 36 visit was the extension study's only visit, which occurred 36 months after randomization in the original DISCOMS study.Population: Subjects missing Neuro-QoL at either DISCOMS baseline or at Month 36 were excluded from this analysis.
The Neuro-QOL Adult PRO short form measures are self-reported measures of overall quality of life and functioning. 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. The change between baseline of the original DISCOMS study (NCT03073603) and Month 36 is reported.
Outcome measures
| Measure |
Discontinuation
n=29 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to discontinue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
Continuation
n=43 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to continue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
|---|---|---|
|
Change in Patient Reported Outcomes (PROs) - NeuroQoL Short Form Scores -- Emotional-Behavioral Dyscontrol
|
0.7 units on a scale
Standard Deviation 7.4
|
-0.3 units on a scale
Standard Deviation 6.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline of the original DISCOMS study (NCT03073603) and Month 36. The Month 36 visit was the extension study's only visit, which occurred 36 months after randomization in the original DISCOMS study.Population: Subjects missing Neuro-QoL at either DISCOMS baseline or at Month 36 were excluded from this analysis.
The Neuro-QOL Adult PRO short form measures are self-reported measures of overall quality of life and functioning. 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. The change between baseline of the original DISCOMS study (NCT03073603) and Month 36 is reported.
Outcome measures
| Measure |
Discontinuation
n=29 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to discontinue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
Continuation
n=43 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to continue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
|---|---|---|
|
Change in Patient Reported Outcomes (PROs) - NeuroQoL Short Form Scores -- Satisfaction With Social Roles and Activities
|
0.9 units on a scale
Standard Deviation 4.5
|
-2.3 units on a scale
Standard Deviation 6.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline of the original DISCOMS study (NCT03073603) and Month 36. The Month 36 visit was the extension study's only visit, which occurred 36 months after randomization in the original DISCOMS study.Population: Subjects missing Neuro-QoL at either DISCOMS baseline or at Month 36 were excluded from this analysis.
The Neuro-QOL Adult PRO short form measures are self-reported measures of overall quality of life and functioning. 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. The change between baseline of the original DISCOMS study (NCT03073603) and Month 36 is reported.
Outcome measures
| Measure |
Discontinuation
n=29 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to discontinue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
Continuation
n=43 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to continue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
|---|---|---|
|
Change in Patient Reported Outcomes (PROs) - NeuroQoL Short Form Scores -- Ability to Participate in Social Roles and Activities
|
-1.1 units on a scale
Standard Deviation 8.3
|
-4.3 units on a scale
Standard Deviation 9.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline of the original DISCOMS study (NCT03073603) and Month 36. The Month 36 visit was the extension study's only visit, which occurred 36 months after randomization in the original DISCOMS study.Population: Subjects missing SymptoMScreen at either DISCOMS baseline or at Month 36 were excluded from this analysis.
SymptoMScreen is a rapid assessment tool that allows the patient to self-report across multiple neurological domains (mobility, hand function, spasticity, pain, sensory, bladder, fatigue, vision, dizziness, cognition, depression, and anxiety). This scale is a user friendly, 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. The change between baseline of the original DISCOMS study (NCT03073603) and Month 36 is reported.
Outcome measures
| Measure |
Discontinuation
n=30 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to discontinue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
Continuation
n=44 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to continue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
|---|---|---|
|
Change in Patient Reported Outcomes (PROs) - SymptoMScreen
|
0 units on a scale
Standard Deviation 0.5
|
0.1 units on a scale
Standard Deviation 0.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline of the original DISCOMS study (NCT03073603) and Month 36. The Month 36 visit was the extension study's only visit, which occurred 36 months after randomization in the original DISCOMS study.Population: Subjects missing PDDS at either DISCOMS baseline or at Month 36 were excluded from this analysis.
The Patient-Determined Disease Steps (PDDS) is a PRO version of the clinician-reported Extended Disability Status Scale (EDSS) which hones the stages of cane use and thus is more responsive to mid-range disability changes. This tool asks the patient to characterize level of disability into one of nine steps (0=normal, 1=mild disability, 2=moderate disability, 3=gait disability, 4=early cane, 5=late cane, 6=bilateral support, 7=wheelchair scooter, 8=bedridden). The PDDS will be used to characterize (and to control for) disability in both study groups at all study time points. The change between baseline of the original DISCOMS study (NCT03073603) and Month 36 is reported.
Outcome measures
| Measure |
Discontinuation
n=29 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to discontinue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
Continuation
n=44 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to continue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
|---|---|---|
|
Change in Patient Reported Outcomes (PROs) - Patient Determined Disease Steps (PDDS)
|
-0.1 units on a scale
Standard Deviation 0.8
|
0.3 units on a scale
Standard Deviation 1.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline of the original DISCOMS study (NCT03073603) and Month 36. The Month 36 visit was the extension study's only visit, which occurred 36 months after randomization in the original DISCOMS study.Population: Subjects missing SDMT at either DISCOMS baseline or at Month 36 were excluded from this analysis.
The SDMT measures patient attention, concentration, and speed of information processing and has been validated for discriminating patients from controls even when it was administered each month over six months. It is relatively simple to administer and only takes a few minutes to complete. Possible scores range from 0 to 110, with higher scores indicating a better outcome. The change between baseline of the original DISCOMS study (NCT03073603) and Month 36 is reported.
Outcome measures
| Measure |
Discontinuation
n=28 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to discontinue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
Continuation
n=43 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to continue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
|---|---|---|
|
Patient Reported Outcomes (PROs) - Change in Symbol Digit Modalities Test (SDMT)
|
4.8 units on a scale
Standard Deviation 10.2
|
1.4 units on a scale
Standard Deviation 7.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline of the original DISCOMS study (NCT03073603) and Month 36. The Month 36 visit was the extension study's only visit, which occurred 36 months after randomization in the original DISCOMS study.Population: Subjects missing MSIS-29 at either baseline or at Month 36 were excluded from this analysis.
Since Neuro-QoL short form doesn't have the ability to provide an overall quality of life calculation, the study team added MSIS-29, which is an acceptable, reliable, and valid method for recording quality of life in MS patients. 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). The change between baseline of the original DISCOMS study (NCT03073603) and Month 36 is reported.
Outcome measures
| Measure |
Discontinuation
n=29 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to discontinue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
Continuation
n=44 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to continue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
|---|---|---|
|
Change in Patient Reported Outcomes (PROs) - Multiple Sclerosis Impact Scale (MSIS-29) -- Psychological Impact
Significant change
|
11 Participants
|
19 Participants
|
|
Change in Patient Reported Outcomes (PROs) - Multiple Sclerosis Impact Scale (MSIS-29) -- Psychological Impact
No significant change
|
18 Participants
|
25 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline of the original DISCOMS study (NCT03073603) and Month 36. The Month 36 visit was the extension study's only visit, which occurred 36 months after randomization in the original DISCOMS study.Population: Subjects missing MSIS-29 at either baseline or at Month 36 were excluded from this analysis.
Since Neuro-QoL short form doesn't have the ability to provide an overall quality of life calculation, the study team added MSIS-29, which is an acceptable, reliable, and valid method for recording quality of life in MS patients. 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). The change between baseline of the original DISCOMS study (NCT03073603) and Month 36 is reported.
Outcome measures
| Measure |
Discontinuation
n=29 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to discontinue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
Continuation
n=44 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to continue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
|---|---|---|
|
Change in Patient Reported Outcomes (PROs) - Multiple Sclerosis Impact Scale (MSIS-29) -- Physical Impact
Significant change
|
11 Participants
|
16 Participants
|
|
Change in Patient Reported Outcomes (PROs) - Multiple Sclerosis Impact Scale (MSIS-29) -- Physical Impact
No significant change
|
18 Participants
|
28 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 36 visit. The Month 36 visit was the extension study's only visit, which occurred 36 months after randomization in the original DISCOMS study.This was developed for qualitative and exploratory purposes. These questions will provide insight into patient satisfaction in regards to the disease modifying therapy (DMT) they are using at baseline, versus their ongoing satisfaction with their study care plan (on a DMT v. not on a DMT). Patients were asked, "How Satisfied Are You with Your Present DMT or Lack of DMT?", and could respond on a five-point scale as Highly unsatisfied, Unsatisfied, Neutral, Satisfied, or Highly Satisfied.
Outcome measures
| Measure |
Discontinuation
n=28 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to discontinue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
Continuation
n=40 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to continue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
|---|---|---|
|
Patient Reported Outcomes (PROs) - Treatment Satisfaction Questions
Very dissatisfied
|
3 Participants
|
5 Participants
|
|
Patient Reported Outcomes (PROs) - Treatment Satisfaction Questions
Dissatisfied
|
0 Participants
|
0 Participants
|
|
Patient Reported Outcomes (PROs) - Treatment Satisfaction Questions
Neutral
|
7 Participants
|
0 Participants
|
|
Patient Reported Outcomes (PROs) - Treatment Satisfaction Questions
Satisfied
|
4 Participants
|
6 Participants
|
|
Patient Reported Outcomes (PROs) - Treatment Satisfaction Questions
Very satisfied
|
14 Participants
|
29 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 36 visit. The Month 36 visit was the extension study's only visit, which occurred 36 months after randomization in the original DISCOMS study (NCT03073603).These questions were also developed for exploratory purposes to gain insight on the MS DMT treatment decisions at the conclusion of the study and to better understand recruitment and retention, for patients who were randomized to either staying on or going off their DMT.
Outcome measures
| Measure |
Discontinuation
n=29 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to discontinue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
Continuation
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to continue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
|---|---|---|
|
Patient Reported Outcomes (PROs) - Treatment Decision Questions (Continuation Group)
Stop my DMT
|
4 Participants
|
—
|
|
Patient Reported Outcomes (PROs) - Treatment Decision Questions (Continuation Group)
Continue my current DMT
|
25 Participants
|
—
|
|
Patient Reported Outcomes (PROs) - Treatment Decision Questions (Continuation Group)
Switch to a new DMT
|
0 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 36 visit. The Month 36 visit was the extension study's only visit, which occurred 36 months after randomization in the original DISCOMS study (NCT03073603).These questions were also developed for exploratory purposes to gain insight on the MS DMT treatment decisions at the conclusion of the study and to better understand recruitment and retention, for patients who were randomized to either staying on or going off their DMT.
Outcome measures
| Measure |
Discontinuation
n=42 Participants
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to discontinue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
Continuation
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to continue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
|---|---|---|
|
Patient Reported Outcomes (PROs) - Treatment Decision Questions (Discontinuation Group)
Stay off my DMT
|
42 Participants
|
—
|
|
Patient Reported Outcomes (PROs) - Treatment Decision Questions (Discontinuation Group)
Restart a prior DMT
|
0 Participants
|
—
|
|
Patient Reported Outcomes (PROs) - Treatment Decision Questions (Discontinuation Group)
Restart a new DMT
|
0 Participants
|
—
|
Adverse Events
Continuation
Discontinuation
Serious adverse events
| Measure |
Continuation
n=30 participants at risk
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to continue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
Discontinuation
n=44 participants at risk
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to discontinue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
|---|---|---|
|
Renal and urinary disorders
Overactive and neurogenic bladder
|
3.3%
1/30 • Number of events 2 • Baseline to end of study (18 months)
All adverse events and serious adverse events are reported.
|
0.00%
0/44 • Baseline to end of study (18 months)
All adverse events and serious adverse events are reported.
|
Other adverse events
| Measure |
Continuation
n=30 participants at risk
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to continue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
Discontinuation
n=44 participants at risk
This study is only observing participants that received an intervention from a previous study. Participants that were randomized to discontinue their disease modifying therapy (DMT) in the DISCOMS study and consent to this extension trial will remain in this arm for the extension.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Increased arthritis pain
|
3.3%
1/30 • Number of events 1 • Baseline to end of study (18 months)
All adverse events and serious adverse events are reported.
|
0.00%
0/44 • Baseline to end of study (18 months)
All adverse events and serious adverse events are reported.
|
|
Reproductive system and breast disorders
pelvic organ prolapse
|
3.3%
1/30 • Number of events 1 • Baseline to end of study (18 months)
All adverse events and serious adverse events are reported.
|
0.00%
0/44 • Baseline to end of study (18 months)
All adverse events and serious adverse events are reported.
|
|
Immune system disorders
chills, fatigue and body aches following COVID-19 vaccine
|
3.3%
1/30 • Number of events 1 • Baseline to end of study (18 months)
All adverse events and serious adverse events are reported.
|
0.00%
0/44 • Baseline to end of study (18 months)
All adverse events and serious adverse events are reported.
|
|
Nervous system disorders
trigeminal neuralgia
|
0.00%
0/30 • Baseline to end of study (18 months)
All adverse events and serious adverse events are reported.
|
2.3%
1/44 • Number of events 1 • Baseline to end of study (18 months)
All adverse events and serious adverse events are reported.
|
|
Infections and infestations
COVID-19 infection
|
3.3%
1/30 • Number of events 1 • Baseline to end of study (18 months)
All adverse events and serious adverse events are reported.
|
0.00%
0/44 • Baseline to end of study (18 months)
All adverse events and serious adverse events are reported.
|
|
Infections and infestations
bronchitis
|
0.00%
0/30 • Baseline to end of study (18 months)
All adverse events and serious adverse events are reported.
|
2.3%
1/44 • Number of events 1 • Baseline to end of study (18 months)
All adverse events and serious adverse events are reported.
|
|
Musculoskeletal and connective tissue disorders
ostopenia
|
0.00%
0/30 • Baseline to end of study (18 months)
All adverse events and serious adverse events are reported.
|
2.3%
1/44 • Number of events 1 • Baseline to end of study (18 months)
All adverse events and serious adverse events are reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place