Monthly Webinar Series July 2019
Today’s Agenda Announcements & Trial Updates Madiha Qutab Recent Enrollments Amanda Bistran-Hall Rowing Competition & Top Enroller Amanda Bistran-Hall Retention Strategies Scott Newsome & Ellen Mowry Q&A All
Announcements & Trial Updates MADIHA QUTAB
Study Updates – Enrollment THANK YOU to activated sites for continuing to screen and enroll patients! We now have 46 sites activated and 236 patients enrolled as of 07/03/19, surpassing our 25% enrollment milestone! CONGRATULATIONS!!! We are in the process of onboarding up to 7 more sites to expand geographic coverage in the US. We enrolled 34 patients across all sites in June, but need to enroll >160 patients each month to reach our goal of 900 patients by the end of October, 2019. All sites need to do their part to make good on the commitment they made to this trial! Please find at least 1 new candidate each week so we can accelerate enrollment!!!
Study Updates - Reminders 1) Starting last month, VISION began generating emails to study coordinators each Monday to address open queries. 2) Responding to queries in a timely manner helps your site and team in the rowboat challenge! 3) Please save and submit for review any page where you have entered data, made a change or responded to a query. Each page that appears “blue” must be submitted for review so the test tube turns “orange” in order for the page to be monitored. 4) All pages for a visit must be submitted for review to receive payment for the visit! THANK YOU for submitting data and uploading source documents promptly!
Study Updates – CRF changes Please visit the study website: http://treat-mstrial.org to download recently updated case report forms (CRFs). The latest updates have V2.2 in the file name and impact the study-long AE, SAE, Concomitant Medications and Protocol Deviations forms as well as Interim Visit, Month 6 follow-up and Month 12 follow-up forms. PLEASE DISCARD OUTDATED CRFs and BEGIN USING THE LATEST CRFs found on the study website.
Study Updates – Coming soon The central IRB has approved version 1.9 of the TREAT-MS trial protocol and version 1.3 of the master Informed Consent Form (ICF). Sites will receive an updated consent form shortly that incorporates recent changes to the protocol, including adding an EDSS exam, timed 25-foot walk test and nine-hole peg test to the months 18, 30 and 42 visits. Subcontract budgets will be amended this fall to include additional payment for these upcoming visits. Current contracting efforts are focused on the BIOBANKING SUBSTUDY funded by the National MS Society. A draft of this new subcontract is being sent to participating sites this summer and retroactive payments will be made for all samples drawn and processed/shipped since 2018 as soon as the subcontract is executed. THANK YOU for continuing to enroll and draw samples for the biobanking substudy!
Recent Enrollments *AS OF MONDAY 07/08/19
DRAKE
The Rowing Competition AMANDA BISTRAN-HALL
Rowing Competition Standings 1. Team E: 60 2. Team A: 55 3. Team F: 48 4. Team B: 46 5. Team H: 44 6. Team D: 41 7. Team C: 26 8. Team G: 20
Rowing Competition Standings Site Points Norton Neurology Services 157 University of Alabama at Birmingham 133 Individual Site Swedish Health Services 112 Gainesville 112 Competition Christiana Care 111 Advanced Neurology Specialists 105 University of Kansas Medical Center 88 Geisinger Clinic 83 University of Washington 81 University of California at Los Angeles 74
Rowing Competition https://treat.preludedynamics.com
Monthly Randomization Race June’s Top Performers: Site Randomizations Norton Neurology Services 4 UCSD 4 Christiana Care 3 Swedish Health 3 Johns Hopkins University 6
June’s Top Enroller: Norton Neurology Services $50
July 2019 Webinar 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
Topics 1. Breakthrough disease, Modified Rio, re-randomization 2. Retention, adherence
TREAT-MS: Objectives 1. . To o evalu luate wheth ther an “early aggressive” therapy approach, versus starting with a traditional th ther erapy, in influ fluen ences th the e in inter ermediate-term risk risk of of dis isabil ilit ity progression. => => Will ill in inves estigate overall ll and with ithin str trata of of peo eople at t high igher ver ersus lo lower risk risk of of lon longer-term dis isabili lity 2. To evaluate if if, , among patients deemed at t lo lower ris risk for dis isability ac accumulatio ion who start on tr traditional, , fir first-line MS th therapies but experience breakthrough dis isease, , th those who switch to a a hig igher-efficacy th therapy ver ersus a new fir first-line th therapy have different in intermediate-term ris risk of f dis isability accumulation.
Risk Strata Determinants Enrollment within 6 months of 1 st attack: high risk if both Clinical or radiographic involvement of the spinal cord OR brainstem/cerebellum AND MRI with >10 T2 lesions OR ≥4 Gadolinium -positive (Gad+) lesions, OR another attack in the first 6 months since the 1 st attack, OR new lesions on MRI if a subsequent MRI is available already Enrollment > 6 months since 1 st attack: high risk if any 2 of the 4 are true Clinical or radiographic involvement of the spinal cord OR brainstem/cerebellum MRI with >10 T2 lesions OR ≥4 Gad+ lesions Residual damage (incomplete recovery based on exam [Functional System Score ≥2 , with the deficit(s) on exam corresponding to the region of prior relapse]) Ongoing activity in the past year: 2 or more relapses OR ≥ 3 new MRI lesions in past year OR ≥2 Gad+ lesions
Original Randomization 1:1 randomization 1:1 randomization
Switch in Therapy for Breakthrough? High risk disability indicators Low risk disability indicators
Defining Breakthrough Disease • ANY breakthrough disease after 6 months on therapy will make allowable a discussion about change in therapy • Treating clinicians required to document discussion of switching therapy if excessive breakthrough has occurred, as defined by “TREAT - MS Maximum Tolerated Modified Rio Score”
TREAT-MS Modified Rio: Applies to Disease Activity that occurs AFTER 6 months on therapy! Patient HAS NOT met modified Rio if: ◦ No relapse, none or only 1 new MRI lesion Patient HAS MET modified Rio if: ◦ Any relapse, or ≥2 new MRI lesions at any single time point these outcomes assessed* ◦ Previously had one new MRI lesion, now acquires one additional MRI lesion* Should be assessed with “annual” MRIs (or earlier, if done earlier in window or at time of a relapse *Remember that disease activity that occurred PRIOR TO 6 FULL MONTHS ON THERAPY is water over the dam! Our reference for treatment failure is anything that happens subsequently/while being treated when medications should be fully “kicked in”
Must the patient switch therapies if they meet maximum disease criteria No. We understand that switching therapy may NOT be indicated at the time! But documentation that therapy switch was discussed is required. Why? Meeting these revised Modified Rio Score criteria= associated with worse intermediate-term disability
MRI logistics: timing of month 6 MRI: AS AGREED UPON BY SAC/SITE PIs Perhaps the most critical MRI in terms of having it, and its timing. Why? ◦ Able to switch therapy for ANY NEW breakthrough disease occurring AFTER 6 months on therapy ◦ Doing the month 6 MRI at the wrong time can reduce the ability to use it to support claim for breakthrough disease: If “month 6” MRI is completed (relative to start date of first therapy) : ≤ 6 months: for the subsequent MRI scan, we will only be able to confirm a new lesion occurred “after 6 months on therapy” if the new lesion is enhancing >6 months-7 months: can serve as true reference MRI scan against which subsequent new lesions can be confirmed as occurring “after 6 months on therapy” >7 months: if a new lesion is present AND enhancing, we can assume it developed “after 6 months on therapy;” if not enhancing, the MRI will simply be a reference MRI scan against which subsequent new lesions can be confirmed Advice: unless you are controlling the scheduling of the “month 6 MRI”, don’t order it until AFTER they have been on the therapy for 6 months. ◦ Consider ordering this MRI at >month 7 on DMT if you strongly believe in using those results to switch therapy
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