Monthly Webinar Series May 2020
Today’s Agenda Trial Updates/Reminders Shannon Hillery Highlights from the TREAT-MS SAC Zoom Meeting on April 10 Scott Newsome & Ellen Mowry Protocol v.2.0 and Consent v.1.4 updates Scott Newsome & Ellen Mowry Monthly Randomization Race Shannon Hillery Q&A All
Trial Updates / Reminders SHANNON HILLERY
Trial Updates/Reminders ➢ As of March 17 th , 2020, when we PAUSED enrollment due to the COVID-19 pandemic we had 477 patients enrolled. ➢ The SAC met by Zoom on April 10, 2020 and voted on the classification of 3 more approved or soon to be approved MS medications (main presentation today) ➢ PCORI granted a 9 month extension on the follow-up period. Some patients will have a M54 and M60 visit and visits will go through August 1, 2023. ➢ The IRB approved Protocol v.2.0 and Master Consent v.1.4 and approval letter, revised protocol and new consent forms were sent out to sites this week. ➢ We will be modifying subcontracts and budgets to include payment for additional visits and questionnaires.
Trial Updates/Reminders ➢ Data collected from visits conducted remotely (tele-visits and phone visits) are to be recorded as interim information ➢ Please contact patients by phone to collect PDDS, at a minimum, if patient missed last protocol-specified visit (window has closed) and enter data under interim information tab. ➢ Please continue to share tele-visit progress notes and collect interim information and data for study-long forms, if possible (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). You may enter data directly into the VISION EDC while speaking with the patient. Research note will serve as source for data collected by phone.
Trial Updates/Reminders ➢ Protocol-specified follow-up visits (e.g., M6, M12, M18, M24, etc.) may be completed if seeing patients in-person, even if all assessments not able to be done ➢ More guidance coming soon regarding re-opening enrollment and resuming other TREAT-MS research activities when permitted locally ➢ Thank you for your hard work and partnership to date!!!
Highlights from the SAC Zoom Meeting held on April 10, 2020 ELLEN M. MOWRY, M.D., M.C.R. SCOTT D. NEWSOME, D.O. ASSOCIATE PROFESSOR OF ASSOCIATE PROFESSOR OF NEUROLOGY AND EPIDEMIOLOGY NEUROLOGY JOHNS HOPKINS UNIVERSITY JOHNS HOPKINS UNIVERSITY
New and Emerging FDA approved DMTs SCOTT NEWSOME AND ELLEN MOWRY
Medication Classes Traditional (First-line) Early Aggressive Glatiramer acetate (Copaxone, Glatopa, other generics) Alemtuzumab (Lemtrada) Intramuscular interferon (Avonex) Ocrelizumab (Ocrevus) Subcutaneous interferon (Betaseron, Extavia, Rebif) Rituximab (Rituxan) Pegylated interferon (Plegridy) Natalizumab (Tysabri) Teriflunomide (Aubagio) Cladribine (Mavenclad) Dimethyl fumarate (Tecfidera) *We held up the Change In Research (CIR) to Diroximel fumarate (Vumerity) add Vumerity and Gilenya generics knowing that Ozanimod was likely going to get approved Fingolimod (Gilenya and generics) and want to be ready for another CIR as soon as Siponimod (Mayzent) Ofatumumab and Ponesimod get approved
Medications Needing SAC Vote (traditional versus early aggressive therapy) • Ozanimod (approved) • Ponesimod (not yet approved) • Ofatumumab (not yet approved) FDA approval of new medications requires vote by SAC to determine if traditional versus early aggressive therapy
Vote based on efficacy in treating inflammatory activity (relapses and new lesions) in the phase 3 trials (or in comparative effectiveness studies)
Ozanimod Approval Sphingosine 1-phosphate receptor modulator, selectively binds to receptor subtypes 1 and 5 (1>5>4) Ozanimod was approved in the last week of March 2020 (brand name: Zeposia); dosing regimen includes titration for first 7 days, with target dose=0.92mg po daily Official marketing launch delayed due to COVID-19
Ponesimod Expected Approval Sphingosine 1-phosphate receptor modulator, selectively binds to receptor subtypes 1 and 5 (1>5>3) Ponesimod new drug application filed March 18 th , 2020 (brand name: ?); dosing regimen 20mg daily- possible titration. Official marketing launch if approved: unknown
Ofatumumab Expected Approval Fully humanized monoclonal antibody- selective depletion of CD20 + B-cells Ofatumumab FDA decision about approval is expected by late June 2020 (brand name ?); Ofatumumab 20mg subcutaneous injection monthly Official marketing launch unknown
SAC VOTE → Ozanimod First-line (Traditional) Therapy → Ponesimod First-line (Traditional) Therapy → Ofatumumab Early Aggressive Therapy SAC Zoom Meeting was recorded and can be found on our trial’s website: http://treat-mstrial.org → Documents section, folder “Study Advisory Committee Meetings” if you are interested in the presentation of data supporting the vote.
Protocol (v.2.0) and Consent (v.1.4) Changes Traditional Therapies Early Aggressive Therapies Glatiramer acetate (Copaxone, Glatopa, and other generics) Natalizumab (Tysabri) Intramuscular interferon (Avonex) Alemtuzumab (Lemtrada) Subcutaneous interferon (Betaseron, Extavia, Rebif) Ocrelizumab (Ocrevus) Pegylated interferon (Plegridy) Rituximab (Rituxan) Teriflunomide (Aubagio) Cladribine (Mavenclad) Dimethyl fumarate (Tecfidera) Diroximel fumarate (Vumerity) Fingolimod (Gilenya and generics) Siponimod (Mayzent) Ozanimod (Zeposia)
Protocol (v.2.0) and Consent (v.1.4) Changes Month Month Month Month Month Month Month Month Month Visit Activity Baseline Month 6 12 18 24 30 36 42 48 54 60 Consent, screening/initial evaluation X Medical history & relapse assessment X X X X X X X X X X X Disability risk classification & randomization X Medication review X X X X X X X X X X X Neurologic exam (blinded assessment of MS X X X X X X X X X X X related disability) MS Functional Composite (timed 25-foot walk X X @ X X @ X X @ X X @ X X @ X test, 9 hole peg test and 3 second addition test) and low-contrast vision test Thought processing speed test X X X X X X Patient rating of MS related disability X X X X X X X Brain MRI & (standard of care) X X X X X X X OCT # (if standard of care) X X X X X X Safety / Adverse event assessment^ X X X X X X X X X X & MRI=magnetic resonance imaging; # OCT=optical coherence tomography; ^ Safety / Adverse event assessment is done for both standard of care and research purposes; @ timed 25-foot walk test and 9 hole peg test only
Protocol (v.2.0) and Consent (v.1.4) Changes Month Month Month Month Month Month Month 60/End Home-based Questionnaires Baseline 3 9 21 33 45 48 of Study Multiple Sclerosis Impact Scale X X X X X X X X Patient rating of disability due to MS X X X X X X X X Neuro-QoL (quality of life) X X X X X X X X Medication adherence survey X X X X X X X Social status (including employment status) and X X X X X lifestyle factors (diet and exercise)
Single Scull Regatta SHANNON HILLERY
Single Scull Regatta Standings
Monthly Randomization Race SHANNON HILLERY
March’s Top Enroller: Christiana Care! $50
Open for Questions
Thank You for attending today’s webinar! Encore performance on Thursday, May 7 th at 9 AM EDT The June Monthly Webinar will be held on the 3 rd at 3 PM and 4 th at 9 AM EDT
Recommend
More recommend
