Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation |
|---|
| Name (Synonyms) | Correlation | |
|---|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting NIH | 0.58 |
| D009103 | Multiple Sclerosis NIH | 0.24 |
| D012598 | Scoliosi NIH | 0.23 |
| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There is one clinical trial.
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.
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 monthsDescription: 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 substudyDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: Low-contrast letter acuity (binocular, 2.5% contrast Sloan charts)
Measure: Low contrast visual acuity Time: up to 63 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 substudyDescription: 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 randomizationDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
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