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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1439 | Early Aggressive Therapy or Traditional Therapy Wiki | 0.58 |
| drug3658 | Repository Corticotropin Injection Wiki | 0.58 |
| drug3714 | Rituximab Wiki | 0.41 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D009103 | Multiple Sclerosis NIH | 0.40 |
| D012598 | Scoliosi NIH | 0.39 |
| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There are 3 clinical trials
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.
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 42Description: 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 42Description: Data will be summarized for each visit.
Measure: Change from Baseline in diastolic/systolic blood pressures Time: Baseline and Up to Day 42Description: 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 42Description: 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 21Description: 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 42The overarching goal of this study is to determine whether rituximab (RTX) offers effectiveness and safety advantages over other commonly used approved Disease-Modifying Drugs (DMT) in the largest real-world population-based structured prospective follow-up cohort of Relapsing-Remitting Multiple Sclerosis (RRMS) patients. The study will include both treatment naïve patients starting their first DMT and patients switching from a previous first line DMT (escalation/second-line).
Description: - Proportion of patients with baseline EDSS ≤2.5 progressing to 12 months confirmed EDSS ≥3 among those over 3 years of follow up
Measure: Confirmed disease progression in patients with Expanded Disability Status Scale (EDSS) ≤2.5 at baseline Time: 3 yearsDescription: - Proportion of patients with baseline EDSS ≥2.5 experiencing 6 months confirmed EDSS increase of 1 point among those over 3 years of follow up
Measure: Confirmed disease progression in patients with EDSS ≥2.5 at baseline Time: 3 yearsDescription: - Change in MSIS-29 over 3 years of follow up (change from baseline; mean value ±SD)
Measure: Disease-related impact on daily life Time: 3 yearsDescription: - Rate of malignancy, cardiovascular disease, serious infections and all-cause mortality in populations on therapy and ever treated, respectively
Measure: Risk and side effect assessments Time: 3-9 yearsDescription: - The occurrence of serious adverse events (SAE) of all types that are possibly or likely related to DMT treatment
Measure: Occurence of Serious Adverse Reactions Time: 3-9 yearsDescription: - Comparison of mean number of relapses per year between the different treatments
Measure: Annual relapse rate Time: 3-9 yearsDescription: - Comparison of mean number of CEL on yearly MRI between the different treatments
Measure: Number of Contrast-enhancing lesions (CEL) Time: 3-9 yearsDescription: - Comparison of yearly increase in mean and median EDSS between the different treatments
Measure: Increase in EDSS Time: 3-9 yearsDescription: - Comparison of yearly proportion of patients with at least 1 step increase in EDSS between the different treatments
Measure: Proportion of patients with at least 1 step increase in EDSS Time: 3-9 yearsDescription: - Comparison of early proportion of patients with No Evidence of Disease Activity (NEDA) -2 (free of exacerbations, new/enlarged T2-lesions and occurrence of CEL) between the treatments
Measure: Proportion of patients with No Evidence of Disease Activity (NEDA) -2 Time: 3-9 yearsDescription: - Comparison of early proportion of patients with NEDA-3 (NEDA-2 plus no worsening of EDSS from baseline) between the treatments
Measure: Proportion of patients with NEDA-3 Time: 3-9 yearsDescription: - Comparison of mean levels of Neurofilament-Light chain (NFL) in serum between the different treatments
Measure: Levels of Neurofilament-Light chain (NFL) in serum Time: 3-9 yearsDescription: - Comparison of yearly brain atrophy rate measured as per cent brain parenchymal fraction (BPF) loss in relation to baseline values between the different treatments
Measure: Brain atrophy rate Time: 3-9 yearsDescription: - Comparison of time to drug discontinuation between the different treatments. Separate analyses will be performed depending on reason to drug discontinuation, mainly side effects and lack of efficacy
Measure: Time on drug Time: 3-9 yearsDescription: Comparison of patient satisfaction with their treatment using the Treatment Satisfaction Questionnaire (TSQ) between the treatments
Measure: Treatment satisfaction Time: 3-9 yearsDescription: - Comparison of health related QoL measured by EQ-5D between the treatments
Measure: Quality of life assessments Time: 3-9 yearsDescription: Comparison of fatigue measured by the Fatigue Scale for Motor and Cognitive Functions (FSMC) between the treatments
Measure: Fatigue Time: 3-9 yearsDescription: - Estimation of total societal costs per year after initiating treatment
Measure: Health economy Time: 3-9 yearsDescription: - Proportion of patients treated with RTX developing high-titer anti-RTX ADA
Measure: Occurrence of Anti-drug antibodies (ADA) Time: 3-9 yearsDescription: - Comparison of mean number of working hours per week between the treatments.
Measure: Employment rate Time: 3-9 yearsDescription: Number of hospital and ICU admittance in people with MS compared to population
Measure: Severity assessments of COVID-19 in MS Time: 1-2 years after COVID-19 epidemicDescription: Number of hospital and ICU admittance in people with MS in relation to DMD
Measure: Severity assessments of COVID-19 in MS in relation to DMD Time: 1-2 years after COVID-19 epidemicFDA-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 December 13, 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