Mo Monthly Webinar Se Series July, 2018 To Todays Agenda - - PowerPoint PPT Presentation

Mo Monthly Webinar Se Series

July, 2018

To Today’s Agenda

• Announcements and Trial Updates

Amanda Bistran-Hall

• Tips for Success: From the Perspective of the Study Coordinator

Madiha Qutab

• Tips for Success: From the Perspective of a Treating Physician

Scott Newsome

• Tips for Success: From the Imaging Analysis Center

Blake Dewey

• Mt. Everest

Christina Grabarits

• Q & A

Team

An Announcem cemen ents

http://treat-mstrial.org

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TR TREAT-MS MS Trial Updates

Enrollment update

First site activated 4/2018- Johns Hopkins University First patient brought in for screening 4/2018 Enrolled: 8 In screening: 3 Reasons for non-participation: pregnancy, randomization, study too demanding/wary of research

TR TREAT-MS MS Trial Updates (continued)

First 4 new sites IRB-approved on 06/21/18!

• Advanced Neurology Specialists – PI: Dr. Dennis Dietrich, Lead Coordinator: Laura Armstrong
• Christiana Care Health Services – PI: Dr. Jason Silversteen, Lead Coordinator: Kathleen Greenbaum
• University of Rochester – PI: Dr. Andrew Goodman, Lead Coordinator: Paul DeRitis
• University of Vermont – PI: Dr. Andrew Solomon, Lead Coordinator: Jane Low

Submitted 5 more sites for IRB approval on 06/27/18

• New York University School of Medicine
• Swedish Health Services
• The University of Texas Southwestern Medical Center
• University of Cincinnati
• University of Florida

Ne Next Steps for Sites

Ø Getting subcontracts partially executed by study sites so they can be fully executed after IRB approval. Ø Completing training and submitting remaining regulatory documents to EDC. Ø Site Activation!

Ne Newly Activated Sites!!!

Christiana Care Health Services on 07/05/18. Advanced Neurology Specialists on 07/09/18.

Welcome aboard!!!

TR TRad aditional al vs. Ear arly y Aggressive Th Therap apy y for Mu Multiple Sclerosis (TREAT-MS MS) Trial: Tips for Success

EL ELLEN EN M. MOWRY (CO-PI PI; TRE REATING PH PHYSICIAN) MA MADIHA QUTA TAB (P (PROJECT MANAGER AN AND STUDY COORDINATOR) SC SCOTT D. NEWSO SOME (C (CO-PI PI; TR TREATI TING PHYSICIAN) BL BLAKE DE DEWEY (I (IMAGING ANALYSIS CENTER)

Objectives

• To review the logistics and address FAQ about

TREAT-MS Trial

• From the perspective of the study

coordinator (Madiha)

• From the perspective of a treating physician

(Ellen/Scott)

• From the Imaging Analysis Center (Blake)

Prep for TREAT-MS Screening/Baseline study visit Access CRFs on TREAT-MS website Add new patient in Vision database Schedule blinded EDSS and blinded MSFC examiners During Visit Provider discusses elements of study with patient Labs pending/labs reviewed and narrowed down treatment options Patient consented/Patient took consent home to review (defer “baseline”)

During Visit

• Follow the baseline study visit checklist
• When consented, ask patient questions on Documentation of Consent form
• Treating Provider goes though I/E criteria and Risk Stratification with the patient

before randomization; with lab results available, provider could narrow down the treatment options with the patient

During visit: Blinded examiners administer MSFC and EDSS Baseline Brain MRI Upload zipped DICOM on the MRI upload page OCT (if standard of care) Complete OCT CRF and upload OCT PDF in Source Docs

ePROs At the study visit, have patient create their vision login to access ePROs; Patient will login to vision and complete PDDS and Social Status ePROs at the visit Challenges: Patient may forget to complete ePROs at home; patient is notified via email to complete ePROs 2 weeks after randomization date/time ePROs not completed within ePRO window (within 45 days from baseline) Strongly encourage patient to complete all ePROs at their visit

After visit Follow-up with patient to confirm DMT start Once CRFs completed in vision, submit for review Once patient completes ePROs, submit for review Follow-up with patient if ePROs not completed in vision Medical/Surgical History, Concomitant medications, and MS DMT will be reviewed and updated at follow-up

Challenges: Multiple study visits on same day If needed, split baseline visit into two days Patients forget to complete ePROs Strongly encourage patient to complete all baseline ePROs at the visit If not completed, follow-up with patients; offer to fax or mail ePROs for patient to send back within study ePRO window (45 days since baseline)

Objectives

• To review the logistics and address FAQ about

TREAT-MS

• From the perspective of the study coordinator

(Madiha)

• From the perspective of a treating physician

(Ellen/Scott)

• From the Imaging Analysis Center (Blake)

Ho How do I identify and enrich the pool of el eligible e candidates es for

• r TRE

TREAT-MS MS?

• Strategies may differ depending on type of clinic and referral

workflow

• At our tertiary MS clinic, a clinic RN screens new referrals; we have

asked her to flag all newly-diagnosed patients and notify us

• If the person may be a TREAT-MS candidate, Scott and/or Ellen makes an

appointment available as an add-on

• Alternatively, we direct the person to a visit with another provider if there is

an opening in their schedule within the next few weeks

• Recruitment materials available for all sites, with space for site-

specific information to be pasted on a label

• We are also working with the CMSC and the National MS Society to

disseminate updates

• Plans are for local email blasts by NMSS in stages, as sites open

If If I I identify a patient as eligible, how do I I di discus uss the he trial with h he her/hi him?

• Key points:
• There is EQUIPOISE in the trial (otherwise we would not be doing it!!)
• A lot of decisions are left up to the clinician/patient (autonomy)
• A little extra time goes a long way
• Very low threshold for switching treatment (allowed if ANY disease

activity occurs after 6 months on therapy)

• Re-randomization at that point ONLY if the person was low-risk for

disability at enrollment AND was initially on a first-line therapy (similar consideration as outside of a trial!)

Pa Patient Logistics (Clinician Pe Perspective)

• Due to need to complete diagnostics, check safety labs, or due to patient

feeling overwhelmed, etc, it is often necessary for newly-diagnosed patients to have more than 1 visit to work through the implications of diagnosis, decide on treatment (even independent of TREAT-MS)

• One of the perks of the “add-on” model is less rushed interaction than

classic clinic appointment

• We call the baseline visit the one in which the patient signs consent form

Pa Patient Logistics (Clinician Pe Perspective), continued:

• At baseline visit, several possibilities of how to approach DMT discussion:
• If safety labs already complete: can randomize and decide on DMT on the

spot

• If safety labs not done/pending: can still enroll. Randomize AFTER safety labs

completed and resulted (although, as long as eligible for at least one early aggressive therapy can randomize- HIV negative and JCV negative)

• Can narrow down therapies within each category (pending safety labs and

randomization), or

• Can bring in for another visit to randomize and/or decide on therapy within

category, or

• Can complete randomization and therapy discussion remotely (e.g. by telephone)

Visit Logistics (Clinician Perspective):

• We have shareable EPIC note templates available that can be used to help

quick data entry into CRFs

• Useful to order the baseline MRI and OCT (if applicable) right at that visit,

and to schedule the month 6 follow-up right at that time as well

• We have medication appeal letters and checklist of disease characteristics

that you can incorporate into clinic notes and/or insurance appeals

• Since meds are all approved for MS, our PRA analysts said notification to

insurance company that patient is in trial NOT required (Recommend NOT stating trial involvement in notes)

Visit Logistics (Clinician Perspective), continued:

• We are working with manufacturers of higher-efficacy therapies to best

understand access programs so as to avoid denials

• Biogen already has a patient access program for natalizumab.
• No response to date from Genzyme (alemtuzumab).
• Genentech rolling out a pilot program that will help those who are

denied ocrelizumab by insurance.

• If patient’s household income $150,000: request “escalation” due to

concern about patient safety with respect to delay of medication startà easy approval

• Available for all patients, not just trial patients

Objectives

• To review the logistics and address FAQ about

TREAT-MS

• From the perspective of the study coordinator

(Madiha)

• From the perspective of a treating physician

(Ellen/Scott)

• From the Imaging Analysis Center (Blake)

Ove Overview: TREAT-MS MS MR MRIs

• Brain MRIs in the TREAT-MS trial are conducted as standard of care
• Schedule of imaging reflects expert consensus guidelines for timing and

frequency of monitoring (Traboulsee et al., AJNR 2016)

• As such, MRIs are billed to insurance as standard of care
• MRI scans are not meant to be extra burdensome to the study team. We

are working hard to standardize the images, however, because:

a) there IS an expert consensus to follow certain minimum MRI parameters, and b) it is the right thing to do. People with MS need answers, and they need our help to

• btain them. We can do this best by getting high-quality imaging.

c) It will help us to ultimately pool TREAT-MS results with DELIVER-MS, for secondary data analyses. We anticipate a governance structure that will allow TREAT-MS investigators to propose use of the dataset in the long-term.

Wh Why do I have to change my existing imaging pr protocol? Am I de depa parting ng from tradi ditiona nal standa ndard d

• f
• f care?

e?

• Many sites will not have to make any alterations to their existing

MRI protocols to fall within our guidelines. These guidelines were developed based on 2016 expert guidelines for MS imaging from the Consortium of Multiple Sclerosis Centers (CMSC) and are currently used across the country as a part of standard of care scanning.

• The guidelines for scanning were distributed in the MRI manual that

was sent out to all sites. If you don’t have a copy, please reach out to the study team. You will not be deviating from standard of care by adopting this guidelines.

• We hope that all sites will strive to comply with these guidelines, as

we feel that accurate, quality imaging will give the study the most impact.

Ca Can I use e a 1.5 T T scanner er?

• We are highly recommending sites use 3T scanners for their

scanning of TREAT-MS patients. 3T scanners offer a great deal of improvement of image quality and allow for better, more consistent follow-up of you patients. If your site does not have access to a 3T scanner, please let our team know and we will work with you to explore other options.

Wh What if my patient’s insurance will not allow them to to have an MRI scan at my institution where the st study protoco col is loaded?

• To address this concern, we have asked each site to identify 1 or 2 “outside”

imaging facilities that have 3T magnets that we can potentially work with to see if they are willing to load a TREAT-compatible sequence on their scanner for their MS scans

• We have been actively working with RadNet, which oversees MULTIPLE imaging

centers in several states (Maryland, Delaware, California, New Jersey, New York, Florida) to install TREAT-compatible sequences on ALL of their 3T scanners, and to ensure their workflow directs MS patients to those scanners

• Once implemented, list of RadNet locations will be sent to sites in those areas;

ultimate goal is to work with additional imaging networks & companies to expand nationwide (not just for TREAT-MS, but to improve our patients’ care universally)

Wh What if my patient has no insurance coverage fo for MRIs?

• Monitoring patients by MRI is an important part of MS care.
• Funds to do imaging are available for financially-eligible patients

every 2 years, through the MS Association of America: https://mymsaa.org/msaa-help/mri/

The The Moun unt Everest Climb

CHRISTINA GRABARITS

• You receive 1 point for attending these

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Activation!

The Summit End of Month 3 Lhotse Wall End of Month 2 Icy Lhotse Wall End of Month 1 Valley of Silence

Receipt of Protocol and Contract

Base Camp

ELEVATION

Mount Everest Standings ccc cc

*Not fit to scale 128.7

• 1. Christiana Care

115.6

• 2. Norton Neurology Specialists
• 3. Columbia Presbyterian

106.6

• 4. University of Cincinnati

76.9 70.5 79.1 152.8 82.3

• 5. NYU School of Medicine
• 7. Cedars Sinai
• 8. Neurology Specialists of Tidewater
• 9. University of Michigan

64.7

• 10. Vanderbilt University Medical Center

98.4

• 6. Advanced Neurology Specialists

https://etm.preludedynamics.com

• Mt. Everest Route

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Op Open for Questions

Thank You for attending today’s webinar!

Encore Performance: Tomorrow 9am

August’s Monthly Webinar: Recruitment and Retention will be held on the 1st at 3pm and 2nd at 9am Eastern