Traditional vs. Early Aggressive Therapy for Multiple Sclerosis TREATMS Mon onthly W Webinar ar Ser Series April, 2018
Today’s A Agenda • Announcements Amanda Bistran-Hall • News and Updates Amanda Bistran-Hall • 90-day Start-Up Overview: Go Live to Site Activation Karen Lane • Q & A Team
Announcements • The Onboarding Webinar was held March 1 st and March 2 nd • Both a PDF copy of the slide presentation and a video recording are available through your Site Managers • Monthly Webinars will be held on the 1 st Wednesday at 3pm Eastern and 1 st Thursday at 9am Eastern of every month • In order to attend, you must register • Contact your Site Managers with any questions! • Carolyn: carolynhkoenig@gmail.com • Sarah: slenington@optonline.net
TREAT-MS M S March Monthly W Webinar • March 1 st at 9am • Providence Health (OR) • 41 attended out of 54 registered (76%) • Neurology Specialists of Tidewater / Meridian Clinical Research • March 2 nd at 11am • New York Presbyterian / Columbia University of Medical Center • New York University School of Medicine • 63 attended out of 74 registered (85%) • Norton Neurology Services Sites Represented: • Ohio Health • Providence Health (OR) • Advanced Neurology Specialists • Rush University Medical Center • Billings Clinic - Billings, MT • Stony Brook University • Cedars Sinai Medical Center • Swedish Medical Center • Central Texas Neurology Consultants • University of Alabama at Birmingham (UAB) • Christiana Care Health System – Newark, DE • University of California, San Francisco (UCSF) • Dignity Health Sacramento (CA) • University of California, Los Angeles (UCLA) • EvergreenHealth Medical Center • University of Cincinnati • Georgetown University • University of Florida, Gainesville Hackensack University Medical Center • • University of Kansas Medical Center (KUMC) • Holy Name Medical Center • University of Kentucky • Icahn School of Medicine at Mount Sinai • University of Louisville (KY) • Johns Hopkins University • University of Miami Massachusetts General Hospital / Harvard University • • University of Pittsburgh • Mayo Clinic • University Rochester • Neurology Specialists of Tidewater / Meridian Clinical Research • University of South Florida Health New York Presbyterian / Columbia University of Medical • • University of Texas Southwestern (UTSW) Center • University of Utah • New York University School of Medicine • University of Washington • Norton Neurology Services • Vanderbilt University Medical Center Ohio Health • • Wayne State University
O U R S I T E M A N AG E R S W I L L B E AWAY Carolyn: Sarah: April 7 – 21 April 12-19 Back-up Managers: Noeleen Amanda Katie Tracey Your back-up Site Managers will be conducting your weekly meetings as scheduled.
Vacation S on Sub ubstitutes es
In Development: Patient Brochure
Didyouknow? To learn more about the There is an unmet need to evaluate TREAT-MS study, please visit: initial therapeutic strategies and [insert website] strategies for switching therapies during the relapsing-remitting phase of [Insert POC name] multiple sclerosis (MS). [Insert POC number] Currently there is a lack of evidence- based guidelines to help MS providers determine which treatment strategy is Togetherwe arestronger best for patients with MS. There are many treatments for MS, but in this study doctors are trying to Join us in our fight to understand which types of treatments improve treatment for are most appropriate to begin with. Multiple Sclerosispatients Funded by: Medical care only improves with the help of volunteers like you. Your participation can help improve the treatment and outcomes of future MS patients. Resources Please see the NMSS and CMSC websites for information on MS: https://www.nationalmssociety.org http://www.mscare.org/
What isTREAT-MS? Whatmedicinewill I take? TREAT-MS is a study where we hope to Most treatments in the TREAT-MS study are identify specific treatments that can prevent, FDA-approved for relapsing-remitting MS. If delay, or lessen disabling effects of multiple you participate, you will be randomly assigned sclerosis (MS) over time. (like a flip of a coin) to one of two standard types of therapy: Who canparticipate? Traditional therapy, such as a shot or oral medication You may be able to participate if you: Early aggressive therapy, such as an Are 18-60 years of age infusion Have relapsing-remitting MS (symptom flare-ups followed by periods with few to With the advice and guidance of your MS no symptoms) Why should Iparticipate? Have not been on chemotherapy in the provider, you will choose the specific therapy past year Satisfaction that you may contribute to within the group you are assigned to that is the Have never been treated with rituximab, improved care for future MS patients best fit for you. ocrelizumab, alemtuzumab, mitoxantrone Help improve decision-making for or cladribine providers and greater community Help Have not been on any disease modifying better understand how to treat people Whathappensat studyvisits? therapy for MS for > 6 months duration with MS Have not been on any MS treatment in the A screening visit to see if the study is right past 6 months We value your participation, and you will be for you Are HIV negative financially compensated for your time. Visit with your MS provider every 6 months for 4 years for medical check-ups and questionnaires HowdoIgetinvolved? Brain MRI at least yearly Please talk with your MS provider to see Brief online questionnaires collected if TREAT-MS is a good fit for you. For between visits more information, please e-mail TREATMS@jhmi.edu or visit [insert website]. [Insert POC name] [Insert POC number]
In Development: Physician Flyer and I/E Card
Inclusion Criteria Aged 18-60 RRMS by 2017 McDonald criteria No chemo in last year TR aditional versus E arly A ggressive HIV negative T herapy for M ultiple S clerosis Must be EITHER JC virus antibody negative or low ( TREAT-MS ) Trial positive (index antibody titer <0.9), OR negative for: Hepatitis B and C, tuberculosis Protocol Number: IRB00143534 There is an unmet need to evaluate initial therapeutic Exclusion Criteria strategies and strategies for switching therapies during Use of any MS DMT in the past 6 months the relapsing-remitting phase of multiple sclerosis (MS). Prior use of rituximab, ocrelizumab, alemtuzumab, Currently there is a lack of evidence- based guidelines mitoxantrone or cladribine to help clinicians determine which treatment strategy is Prior use of any other MS DMT for > 6 months best for patients with MS. duration Use of other investigational drugs for MS Use of teriflunomide in past 2 years without a washout Women who are pregnant, breastfeeding, or of About the Study child-bearing age who are considering conception Randomized controlled trial in people with during the study relapsing-remitting Multiple Sclerosis (RRMS) Study Activities N=900 Stratified by higher vs. lower risk for long term Study participation: 48+ months disability Evaluation includes: standardized neurologic Randomized 1:1 to early aggressive vs. traditional exam/disability measures and other performance disease-modifying therapy (DMT) class (specific measures therapy within assigned therapy class at the Standard-of-care brain MRIs at baseline, 6 months, discretion of you and your patient) 12 months and annually thereafter Routine Optical Coherence Tomography tests annually at select sites Clinic evaluation every 6 months Collect electronic patient reported outcomes Contact Information POC Name: [Insert] Email: [Insert] Phone: [Insert] Funded by: Principal Investigators: Ellen M. Mowry, MD, MCR and Scott D. Newsome, DO
Updates from Trial Leadership
March 27 April 19 Protocol v1.6 & consent Completed LCQ due (2 weeks) template approved by JHM IRB! TREAT-MS Trial Update Protocol, consent form template and local context questionnaire (LCQ) to sites April 5 (today!)
Once sites receive JHM IRB approval, subcontracts will be finalized and Payment for executed Start-Up Once 90 day activities are Activities completed, sites will be activated and start-up payments will be sent!!!
Updates Regarding our Website
IRB Reliance & Subcontracts Karen Lane
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