Monthly Webinar Series July 2020
Today’s Agenda Trial Updates/Reminders Sandi Cassard PCORI COVID-19-Related Enhancement for Existing Research Background Ellen Mowry & Scott Newsome Specific Aims Ellen Mowry & Scott Newsome Substudy Design & Outcomes Ellen Mowry & Scott Newsome Single Scull Regatta Competition Shannon Hillery Monthly Randomization Race Shannon Hillery Q&A All
Trial Updates / Reminders SANDI CASSARD
Trial Updates/Reminders As of July 7 th , 2020, 485 patients have been enrolled. 21 sites have re-opened to enrollment over the past two months. Welcome to Medical College of Wisconsin, Dr. Ahmed Obeidat , site PI and Sam O’Dell , lead coordinator, our newest participating site that was activated to enroll on July 7 th !!! Remaining sites on-hold need to request permission to re-open to enrollment and other research activities (reach out to Sandi Cassard). Biobanking: UAB re-opened and is receiving/processing samples. Biobanking questions and/or need more supply kits - reach out to Susan Emrich
Trial Updates/Reminders Database lock was on June 30 th , 2020, in preparation for next DSMB report; reach out to your site monitor (Mason, Jesse, Jen, or Sandi) with any questions related to data entry and queries. Data collected from visits conducted remotely (tele-visits and phone visits) should continue to be recorded as interim information. Please continue to share tele-visit progress notes and collect interim information and data for study-long forms (e.g. concomitant meds/therapies, MS signs and symptoms, MRI/relapse assessment, Breakthrough disease, DMT changes, therapy decision factors, AEs / SAEs, updates to medical/surgical history). Thank you for your continued hard work and partnership to date!!!
PCORI COVID-19 19-Related Enhancement for Existing Research ELLEN M. MOWRY, M.D., M.C.R. SCOTT D. NEWSOME, D.O. PROFESSOR OF NEUROLOGY AND ASSOCIATE PROFESSOR OF EPIDEMIOLOGY NEUROLOGY JOHNS HOPKINS UNIVERSITY JOHNS HOPKINS UNIVERSITY
Background ELLEN MOWRY AND SCOTT NEWSOME
COVID-19 Impact & Concerns • Pandemic has caused clinical care and research disruptions world wide • People with MS and their clinicians, are fearful that MS or the MS therapy they are using may increase the risk or severity of COVID-19 infection: => these fears may be amplified for newly diagnosed people (in general) => fears may differ for patients in TREAT-MS depending on their randomization and current therapy
COVID-19 Impact & Concerns • It is unclear whether a person with early MS is more likely to experience more severe COVID-19 if treated with a higher-efficacy therapy- increases awareness of equipoise of initial treatment choice • Unknown if COVID-19-induced disruptions in therapy or other clinical care increase MS disease activity or MS symptoms; extremely relevant since greater MS activity early on is associated with worse long-term outcomes • It is unclear if pre-pandemic anxiety and depression contribute to decisions to alter disease-modifying therapy or care
PCORI Enhancements • Supplements to ongoing, funded projects to generate “timely findings to provide answers to dilemmas facing patients, clinicians, health systems, and other stakeholders and entities battling the novel coronavirus pandemic in the United States .” • Intended to be conducted within 12 months • TREAT-MS team applied for/received an enhancement (one of two for MS)
Specific Aims ELLEN MOWRY AND SCOTT NEWSOME
Aim 1 • To evaluate if patients enrolled in TREAT-MS delayed or altered their disease- modifying therapy schedule or other MS care, and whether such alterations are associated with a greater degree of breakthrough inflammatory disease activity or the development of new (or worsening baseline) MS symptoms. Rationale: Patients with MS may face COVID-19-related changes in MS monitoring or treatment adherence, which may influence the a) degree of inflammatory disease activity (MS relapses and new lesions) or b) burden of MS symptoms. We will also explore whether pre-pandemic anxiety or depression contribute to decisions to alter disease-modifying therapy or care and, if so, whether the association differs by treatment class (higher-efficacy vs. traditional).
Aim 2 • To evaluate if patients with MS treated with higher-efficacy, versus traditional, therapies differ in the risk of severe COVID-19 infection, defined as requiring hospitalization (with or without intubation) or mortality due to COVID-19. Rationale: Higher-efficacy treatments may increase the risk of more severe COVID-19 infection. Understanding these risks is important to informing future patients with MS with respect to making disease- modifying therapy choices.
Study Design & Outcomes ELLEN MOWRY AND SCOTT NEWSOME
Overview • Those eligible include all enrolled and being followed as of 3/16/2020 (n=460) • Duration: 48 weeks • Week 0 visit is any visit that occurred between 3/16/2020 and 9/15/2020 that is documented in our TREAT-MS database as an interim visit • Collecting data will be flexible, at either in-person clinical care visits or remotely (video or telephone visits); most “new” data to be collected by coordinators • We will leverage data collected during this enhancement period against previously-collected, pre-COVID-19 outcomes when relevant • TREAT-MS Project Manager to oversee activities
Schedule of Activities *includes all non-physical assessments per main TREAT-MS protocol including relapse assessment, MS symptom verification, evaluation of breakthrough disease **includes COVID-19 symptom assessment, test results, hospitalization and outcomes, and degree of social distancing
Primary Outcome • Change in Overall Burden of MS * - change in overall burden of MS will be defined for this study as: Occurrence of breakthrough disease (relapses or new MRI activity) OR Development of new or worsening of baseline MS symptoms *documented at clinical visits, whether in-person or on tele-visits
Secondary Outcomes • Severe COVID-19 Infection: defined as an outcome of “hospitalization or death” due to confirmed or suspected COVID-19 infection; this will be the primary outcome for Aim 2. -All patients will be queried about COVID-19 symptoms, testing, hospitalization, care during hospitalization, and treatments/outcomes during hospitalization, including mortality (which will also be assessed independent of hospitalization). -Coordinators will obtain hospital records (with permission) from patients so that the treating clinician can verify medical details; calls to emergency contacts can be made for patients for whom contact can’t be directly established to evaluate if death has occurred.
Secondary Outcomes, continued • Change in Neuro-QoL Anxiety Subscale: full Neuro-QoL health-related quality of life battery is already collected for TREAT-MS patients at baseline and at months 3, 9, 21, 33, 45, 48, and 60. -In order to ensure there are not systematic differences in the timing and frequency of collection, we will collect the Anxiety Subscale at the start of the enhancement period and approximately quarterly, with the final assessment at week 48. • Change in Neuro-QoL Depression: As above, we will collect the Depression Subscale quarterly in the enhancement period.
Predictors & Covariates • Alterations in Disease-Modifying Therapy and MS Care: primary predictor for Aim 1 • Treatment Strategy: primary predictor for Aim 2 (higher-efficacy vs. traditional) • Social Distancing: evaluate degree to which patients isolate themselves throughout the pandemic (covariate for both aims) • Modified Social Support Survey: social support will be evaluated as a possible covariate
Analysis Plan • Evaluate overall MS burden during the study period, first in all subjects and then by treatment group (Aim 1)* • Evaluate differences in severe COVID-19 related illness (Aim 2)* • Evaluating anxiety as an outcome- detect a 3-point difference in the early aggressive, higher-efficacy therapy group vs. traditional *adjusting for covariates
Single Scull Regatta SHANNON HILLERY
Single Scull Regatta Standings
Monthly Randomization Race SHANNON HILLERY
June’s Top Enroller: Swedish Health Services! $50
Open for Questions
Thank You for attending today’s webinar! Encore performance on Thursday, July 9 th at 9 AM EDT The August Monthly Webinar will be held the 1st week of August on the 5 th at 3 PM and 6 th at 9 AM EDT.
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