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D020529: Multiple Sclerosis, Relapsing-Remitting

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (3)


Name (Synonyms) Correlation
drug1146 Early Aggressive Therapy or Traditional Therapy Wiki 0.71
drug2870 Repository Corticotropin Injection Wiki 0.71
drug2505 Placebo Wiki 0.03

Correlated MeSH Terms (2)


Name (Synonyms) Correlation
D012598 Scoliosi NIH 0.39
D009103 Multiple Sclerosis NIH 0.39

Correlated HPO Terms (0)


Name (Synonyms) Correlation

Clinical Trials

Navigate: Correlations   HPO

There are 2 clinical trials


1 A Multicenter, Randomized, Double Blind, Placebo Controlled Parallel Group, Pilot Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in Subjects With Relapsing-remitting Multiple Sclerosis

This is a multicenter, multiple dose study to estimate the response rate, and examine the safety of H.P. Acthar® Gel (Acthar) in subjects with RRMS who have not responded to high dose steroids. Approximately 66 subjects will be randomized.

NCT03126760
Conditions
  1. Relapsing, Remitting Multiple Sclerosis
Interventions
  1. Drug: Repository Corticotropin Injection
  2. Drug: Placebo
MeSH:Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Sclerosis

Primary Outcomes

Description: The EDSS is a 10 step assessment of neurological impairment/disability in MS ranging from 0 (normal neurological examination) to 10 (death due to MS) that is completed by a blinded rater. The blinded rater will not be involved in any aspects of participant care and management other than performing the EDSS/FSS evaluations in participant in the study.

Measure: Response rate on Expanded Disability Status Scale (EDSS) at Day 42

Time: Day 42

Description: Data for AE and SAE will be presented.

Measure: Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time: Up to Day 42

Description: Data will be summarized for each visit.

Measure: Change from Baseline in diastolic/systolic blood pressures

Time: Baseline and Up to Day 42

Measure: Change from Baseline in respiratory rate

Time: Baseline and Up to Day 42

Measure: Change from Baseline in heart rate

Time: Baseline and Up to Day 42

Measure: Change from Baseline in body temperature

Time: Baseline and Up to Day 42

Measure: Change from Baseline in Clinically Significant Laboratory Test Abnormalities - Hematology

Time: Baseline and Up to Day 42

Measure: Change from Baseline in Clinically Significant Laboratory Test Abnormalities - blood chemistry

Time: Baseline and Up to Day 42

Measure: Change from Baseline in Clinically Significant Laboratory Test Abnormalities -urinalysis

Time: Baseline and Up to Day 42

Secondary Outcomes

Description: The MSIS-29 measures the physical (20 items) and psychological (9 items) impact of MS from the participant's perspective. This validated questionnaire will result in a total score between 29 and 145 and can provide separate scores for physical and psychological impact. The MSIS-29 will be completed by the participant at all required times points during the study except on Study Day 14 when the MSIS-29 will be administered via telephone by a call center trained in the administration of the MSIS-29 or captured via a web portal.

Measure: The response rates on Multiple Sclerosis Impact Scale Version 1 (MSIS-29) and 90% confidence intervals (CIs)

Time: Days 7, 14, 21 and 42

Description: The EDSS is a 10 step assessment of neurological impairment/disability in MS ranging from 0 (normal neurological examination) to 10 (death due to MS) that is completed by a blinded rater. The blinded rater will not be involved in any aspects of participant care and management other than performing the EDSS/FSS evaluations in participant in the study.

Measure: The response rates on EDSS and 90% CIs on Day 7 and Day 21

Time: Days 7 and 21

Description: The CGI-I was developed for use in clinical research to provide a brief overview of the change in a participant's global function compared to baseline and regardless of study drug treatment. It requires a rating from 1 (very much improved) to 7 (very much worse).

Measure: Clinical Global Impression of Improvement Scale (CGI-I) mean scores and 90% CIs

Time: Days 7, 21 and 42
2 A Pragmatic Trial to Evaluate the Intermediate-term Effects of Early, Aggressive Versus Escalation Therapy in People With Multiple Sclerosis

FDA-approved multiple sclerosis (MS) disease-modifying therapies (DMTs) target the relapsing phase of MS but have minimal impact once the progressive phase has begun. It is unclear if, in the relapsing phase, there is an advantage of early aggressive therapy with respect to preventing long-term disability. The infectious risks and other complications associated with higher-efficacy treatments highlight the need to quantify their effectiveness in preventing disability. The TRaditional versus Early Aggressive Therapy for MS (TREAT-MS) trial is a pragmatic, randomized controlled trial that has two primary aims: 1) to evaluate, jointly and independently among patients deemed at higher risk vs. lower risk for disability accumulation, whether an "early aggressive" therapy approach, versus starting with a traditional, first-line therapy, influences the intermediate-term risk of disability, and 2) to evaluate if, among patients deemed at lower risk for disability who start on first-line MS therapies but experience breakthrough disease, those who switch to a higher-efficacy versus a new first-line therapy have different intermediate-term risk of disability.

NCT03500328
Conditions
  1. Multiple Sclerosis, Relapsing-Remitting
Interventions
  1. Other: Early Aggressive Therapy or Traditional Therapy
MeSH:Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Sclerosis

Primary Outcomes

Description: Time to sustained disability progression is measured by the Expanded Disability Status Scale plus (EDSS+): a composite endpoint that includes EDSS change (change at any 6 month time point of > 1.0 point if baseline EDSS is < 5.5 or of > 0.5 if baseline EDSS is > 6.0, that is sustained 6 months later) OR 20% worsening on either of two specific components of the Multiple Sclerosis Functional Composite (MSFC), the timed 25-foot walk test (T25FWT) and the nine hole peg test (9HPT) that is sustained 6 months later.

Measure: Time to sustained disability progression

Time: From date of randomization until the date of first documented sustained disability progression, up to 63 months

Description: The change in overall burden of MS will be defined for the COVID-19 related substudy as the occurrence of breakthrough disease (relapses or new MRI activity) or the development of new (or worsening baseline) MS symptoms, which are (for TREAT-MS) and will continue to be (during the substudy) documented at clinical visits, whether in-person or on tele-visits.

Measure: Change in Overall Burden of MS

Time: up to 48 weeks from enrollment into COVID-19 related substudy

Secondary Outcomes

Description: PDDS is a self-assessment scale of disability due to MS on a scale from 0 to 8 and will be administered as an electronic patient-reported outcome (PRO).

Measure: Patient-Determined Disease Steps (PDDS)

Time: up to 63 months

Description: The MSFC consists of the timed 25 foot walk test, the 9-hole peg test, and the Paced Auditory Serial Addition Test (PASAT) and a composite MSFC z-score will be evaluated.

Measure: Multiple Sclerosis Functional Composite (MSFC) Composite Score

Time: up to 63 months

Description: Time taken to complete the timed 25 foot walk test, measured twice in units of seconds, will be averaged and evaluated.

Measure: Timed 25 Foot Walk Test

Time: up to 63 months

Description: Time taken to complete the nine-hole peg test, measured twice for each hand (dominant and non-dominant) in units of seconds, will be averaged for each hand and evaluated.

Measure: Nine-hole Peg Test

Time: up to 63 months

Description: The paced auditory serial addition test that measures processing speed will be administered once; number and percent correct will be evaluated.

Measure: Paced Auditory Serial Addition Test (PASAT)

Time: up to 63 months

Description: Low-contrast letter acuity (binocular, 2.5% contrast Sloan charts)

Measure: Low contrast visual acuity

Time: up to 63 months

Description: Among participants identified to have a relapse, relapse recovery will be defined as complete or incomplete based on patient self-report.

Measure: Patient-reported incomplete relapse recovery

Time: up to 63 months

Description: Among participants identified to have a relapse, relapse recovery will be defined as complete or incomplete based on neurologic examination (those who have increased Functional System scores, corresponding to the relapse symptoms, of 1.0 point or greater for at least 6 months after the relapse onset, without subsequent accrual of worsening in that same Functional System (e.g. more indicative of progression), will be considered to have incomplete relapse recovery).

Measure: Neurologic exam-based incomplete relapse recovery

Time: up to 63 months

Description: The SDMT is commonly used in MS to assess processing speed and will be administered orally and used to evaluate changes in cognition throughout the study.

Measure: Cognition using Symbol Digit Modality Test (SDMT)

Time: up to 63 months

Description: The MSIS-29 will be used to evaluate the impact of MS on the participants and will be administered as an electronic PRO.Multiple Sclerosis Impact Scale (MSIS-29) is an instrument used for measuring the physical (20 items) and psychological (nine items) impact of multiple sclerosis.

Measure: Multiple Sclerosis Impact Scale (MSIS-29)

Time: up to 63 months

Description: The Anxiety Subscale of Neuro-QoL will be administered as an electronic PRO.

Measure: Quality of Life in Neurological Disorders (Neuro-QoL): Anxiety Subscale

Time: up to 63 months

Description: The Depression Subscale of Neuro-QoL will be administered as an electronic PRO.

Measure: Quality of Life in Neurological Disorders (Neuro-QoL): Depression Subscale

Time: up to 63 months

Description: The Fatigue Subscale of Neuro-QoL will be administered as an electronic PRO.

Measure: Quality of Life in Neurological Disorders (Neuro-QoL): Fatigue Subscale

Time: up to 63 months

Description: The Upper Extremity Function Subscale of Neuro-QoL will be administered as an electronic PRO.

Measure: Quality of Life in Neurological Disorders (Neuro-QoL): Upper Extremity Function

Time: up to 63 months

Description: The Lower Extremity Function Subscale of Neuro-QoL will be administered as an electronic PRO.

Measure: Quality of Life in Neurological Disorders (Neuro-QoL): Lower Extremity Function

Time: up to 63 months

Description: The Cognitive Function Subscale of Neuro-QoL will be administered as an electronic PRO.

Measure: Quality of Life in Neurological Disorders (Neuro-QoL): Cognitive Function

Time: up to 63 months

Description: The Positive Affect/Well-being Subscale of Neuro-QoL will be administered as an electronic PRO.

Measure: Quality of Life in Neurological Disorders (Neuro-QoL): Positive Affect/Well-being

Time: up to 63 months

Description: The Sleep Disturbance Subscale of Neuro-QoL will be administered as an electronic PRO.

Measure: Quality of Life in Neurological Disorders (Neuro-QoL): Sleep Disturbance

Time: up to 63 months

Description: The Ability to Participate in Social Roles and Activities Subscale of Neuro-QoL will be administered as an electronic PRO.

Measure: Quality of Life in Neurological Disorders (Neuro-QoL): Ability to Participate in Social Roles and Activities

Time: up to 63 months

Description: The Satisfaction with Social Roles and Activities Subscale of Neuro-QoL will be administered as an electronic PRO.

Measure: Quality of Life in Neurological Disorders (Neuro-QoL): Satisfaction with Social Roles and Activities

Time: up to 63 months

Description: The Stigma Subscale of Neuro-QoL will be administered as an electronic PRO.

Measure: Quality of Life in Neurological Disorders (Neuro-QoL): Stigma

Time: up to 63 months

Description: The incidence of change in employment to "disabled" or "looking for work, unemployed," will be evaluated for all participants through an electronic PRO.

Measure: Employment status

Time: up to 63 months

Description: Incident divorce or separation, among those who previously were married or in a domestic partnership, will be evaluated for all participants through an electronic PRO.

Measure: Marital status

Time: up to 63 months

Description: SAEs (clinically significant infections, malignancies, or the development of other serious comorbidities, as well as unplanned hospitalizations [for non-elective issues, excluding MS relapse] and death)

Measure: Serious Adverse Events (SAEs)

Time: up to 63 months

Description: Adverse events meaningful enough to lead to medication discontinuation

Measure: Adverse event resulting in a decision to change disease-modifying therapy

Time: up to 63 months

Description: Severe COVID-19 infection will be defined as an outcome of "hospitalization or death" due to confirmed or suspected COVID-19 infection

Measure: Severe COVID-19 Infection

Time: up to 48 weeks from enrollment into COVID-19 related substudy

Other Outcomes

Description: Changes in brain MRI measures of neurodegeneration, including whole brain and normalized gray matter volumes, cortical thickness, subcortical gray matter compartment volumes, and measures of T2 lesion burden.

Measure: Brain Magnetic Resonance Imaging (MRI) evidence of neurodegeneration

Time: From 6 months after starting 1st therapy up to 63 months after randomization

Description: The number of relapses (new or worsening neurologic symptoms lasting for 24 hours or more in the absence of fever).

Measure: Number of relapses

Time: up to 63 months

Description: The number of new/enlarging T2-weighted hyperintense lesions and T1-weighted hypointense lesions will be quantified on each MRI scan

Measure: Number of new brain lesions on MRI

Time: up to 63 months

Description: Retinal nerve fiber layer and ganglion cell/inner plexiform thickness will be evaluated among patients at centers and offices with access to OCT as standard of care

Measure: Retinal layer thickness by Optical Coherence Tomography (OCT)

Time: up to 63 months

Description: As an exploratory outcome, the number of newly-prescribed or dose-escalated medications used for treating MS symptoms (including pain, weakness, numbness/tingling, trouble walking, cognitive problems, fatigue, depression, anxiety, visual dysfunction, spasticity, vertigo, or bladder/bowel/sexual dysfunction) during the trial will be evaluated using the electronic health record. In addition, non-pharmacologic interventions (and referrals to other healthcare providers) for symptom management will also be captured.

Measure: Number of new medications, escalated dosage of medications, and non-pharmacologic interventions for MS-related symptoms

Time: up to 63 months

HPO Nodes


HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


HPO Nodes


Reports

Data processed on September 26, 2020.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

Drug Reports   MeSH Reports   HPO Reports  

Interventions

4,180 reports on interventions/drugs

MeSH

691 reports on MeSH terms

HPO

263 reports on HPO terms

All Terms

Alphabetical index of all Terms

Google Colab

Python example via Google Colab Notebook