Monthly Webinar Series January 2020
Today’s Agenda Announcements & Trial Updates/Reminders Sandi Cassard Breakthrough Disease and DMT Change - Refresher Ellen Mowry, Scott Newsome Monthly Randomization Race Daniel Amirault Q&A All
Announcements & Trial Updates
Enrollment News As of Tuesday, January 7th, we have enrolled 414 patients toward our goal of 900! We are rapidly approaching the half-way mark, and we are grateful for your partnership. WE’VE GOT THIS, as a team. Please continue to screen and enroll patients while we work on a contract extension with PCORI. Please try to find at least 1 new candidate each week so we can accelerate enrollment!!!
Weekly Enrollment Trackers • Graphical representations of the # enrolled versus the # YOU PLEDGED TO ENROLL • Have been modified to meet our new target enrollment completion of 6/2020 TREAT-MS Trial UAB Example of site on track: 25 20 15 10 5 0 Enrollment Commitment Current Enrollment
10 15 20 25 0 5 July-18 August-18 September-18 October-18 Example of sites that need to ramp up: November-18 December-18 January-19 Enrollment Commitment February-19 March-19 TREAT-MS Trial April-19 May-19 Site A June-19 July-19 August-19 Current Enrollment September-19 October-19 November-19 December-19 January-20 February-20 March-20 April-20 May-20 June-20 10 15 20 25 0 5 Enrollment Commitment TREAT-MS Trial Site B Current Enrollment
Enrollment Considerations If You Are Behind: Major Blockages • Your center is not seeing enough newly-diagnosed, untreated patients • Solutions: you may need to reach out to referring clinicians at your institution or in the community, speak at Grand Rounds, engage your patient-partner • You may not be catching people “in time”– consider that you may need to open up some “priority” slots with site PI for newly - referred patients to the center and see those patients quickly, before referring physicians begin therapy • Your colleagues don’t refer to the trial • You may need to re-explain the equipoise of the study, the high degree of physician-patient autonomy, and the flexibility (and even urging) of treatment switches for breakthrough disease • You may need to ensure the site PI is seeing potentially eligible patients • Your patients don’t seem interested/already have a treatment in mind • You likely need to spend more time with the patient (ensure at least 2 visits, bring up the trial at visit #1) • Usually best for the physician/clinician to explain trial and go over consent form • You may need to check your own explanation of equipoise REMEMBER…. THERE ARE PLENTY OF SITES THAT HAVE REACHED AND ARE NOW PURSUING HIGHER TARGETS. THESE GOALS ARE READILY ACCOMPLISHABLE. YOU MADE THE PLEDGE TO DO IT…. SO PLEASE COMMIT TO FIGURING OUT YOUR BLOCKAGES AND MOVING PAST THEM! REACH OUT TO THE SITE PIS OR TO OTHERS WHO ARE SUCCEEDING TO GET TIPS!
Upcoming Important Dates ◦ January 10, 2020 – You will receive continuing review materials from the Johns Hopkins Coordinating Center (JHCC) to review / edit – make sure VISION is up-to-date NOW!!! ◦ January 17, 2020 – Continuing review materials due back to JHCC ◦ January 24, 2020 – Target date for submission of all sites to central IRB for continuing review ◦ January 31, 2020 – DSMB meeting ◦ February 26, 2020 – SAC Meeting – West Palm Beach, Florida
Study Updates - Reminders 1) When consenting patients for the trial, please document the consent process, as detailed in the protocol and MOP, and upload signed consent form and completed DOC process form to VISION database under Source Docs tab, item # 10. 2) PLEASE ENTER VISIT DATA WITHIN 1 WEEK OF THE VISIT AND UPLOAD PDFs of SOURCE DATA SO WE CAN MONITOR THE DATA! We need all visit CRFs to verify the data. CRFs may be scanned as a single PDF, if preferred, and uploaded under Source Docs tab, item # 9.
Consent documentation
Study Updates - Reminders 3) Please visit study website (http://treat-mstrial.org – Documents section) for most up-to-date case report forms (CRFs). 4) Please share webinar slides with study team members that are unable to attend live presentations. 5) Reach out to the coordinating center if you have a patient that wants to withdraw or is having trouble getting started on DMT. 6) Promptly report any SAE (e.g., unplanned hospitalization) in VISION so we can inform our medical monitor and the IRB!
Breakthrough Disease and DMT Change ELLEN MOWRY & SCOTT NEWSOME
Original Randomization 1:1 randomization 1:1 randomization
Who Gets Re-randomized for Breakthrough? High risk disability indicators Low risk disability indicators
Switch in Therapy for Breakthrough? High risk disability indicators Low risk disability indicators • The other patients do not have a re-randomization for first breakthrough if they are changing therapy • If patients in the re-randomized group have a second breakthrough after 6 months on THAT therapy, there is no more randomization
Defining Breakthrough Disease • ANY breakthrough disease after 6 months on therapy will make allowable a discussion about change in therapy • Gadolinium-enhancing lesions can be used as evidence of breakthrough disease activity if the “month 6” first on treatment MRI is performed after 7 months on therapy • Treating clinicians required to document discussion of switching therapy if excessive breakthrough has occurred • Excessive breakthrough= >1 new lesion, or any relapse, after the time periods noted above
“Month 6” MRI – Timing and Interpretation Doing the “month 6” MRI too early can reduce the ability to use it to support a claim for breakthrough disease. If the “month 6” MRI is completed: < 6 months after starting on therapy: For the subsequent MRI scan (month 12 MRI), treating clinician will only be able to confirm a new lesion occurred “after 6 months on therapy” if the new lesion is enhancing. > 6 months to 7 months after starting on therapy: Scan can serve as a true reference MRI scan against which subsequent new lesions can be counted as occurring “after 6 months on therapy.” > 7 months after starting on therapy: If a new lesion is present AND enhancing, treating clinician 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.
Scheduling logistics for MRIs: Examples Question: What is the window for getting the Month 6 MRI completed? How about the Month 12 MRI? Answer: The Month 6 MRI should be completed after the patient has been on his/her 1 st DMT for AT LEAST 6 months. For setting up your visit tracker and optimal timing of the Month 6 MRI, see below example: Example 1: DMT started within 2 months of randomization Randomization date: 02/15/19 DMT start date: 03/25/19 Month 6 MRI: after 09/25/19, assuming patient has remained on the same DMT for 6 months Month 6 MRI if you suspect new activity and want to use it as evidence of breakthrough disease: after 10/25/19. Month 12 MRI: based on randomization date. Visit window is wide (9 months after randomization up to 18 months after randomization – between 11/15/19 and 8/15/20). Please order it when it is clinically indicated.
Scheduling logistics for MRIs: Examples Question: What is the window for getting the Month 6 MRI completed? How about the Month 12 MRI? Answer: The Month 6 MRI should be completed after the patient has been on his/her 1 st DMT for AT LEAST 6 months. For setting up your visit tracker and optimal timing of the Month 6 MRI, see below example: Example 2: Delay in start date for DMT Randomization date: 02/15/19 DMT start date: 5/12/19 Month 6 MRI: after 11/12/19, assuming patient has remained on the same DMT for 6 months Month 6 MRI if you suspect new activity and want to use it as evidence of breakthrough disease: after 12/12/19. You may still label and upload this as a Month 6 MRI, even if it falls within the early part of the Month 12 MRI visit window. Month 12 MRI: Visit window is wide (9 months after randomization up to 18 months after randomization – between 11/15/19 and 8/15/20). Please order it when it is clinically indicated.
Early DMT Changed – MRI timing Question: Our patient took her 1 st DMT for 2 months, then discontinued due to side effects. She is starting her next DMT within the same treatment class within a month of discontinuing the 1 st medication. When should we obtain her month 6 MRI? How about her month 12 MRI? Answer: This patient can be re-baselined prior to starting the 2 nd DMT, and then the month 6 MRI will be after the patient has been on this 2 nd DMT for at least 6 months. The re-baseline can be uploaded in the month 6 MRI slot and the MRI after 6 months on the 2 nd DMT can be uploaded as a month 12 MRI. Example: Baseline MRI: 12/15/18 Next MRI: 06/15/19 (upload as month 6 MRI) 2 nd DMT start date: 6/20/19 Randomization date: 2/15/19 1 st DMT start date: 3/25/19 Next MRI: 01/25/20 (upload as month 12 MRI) 1 st DMT stop date: 5/25/19
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