Monthly Webinar Series January, 2019 Todays Agenda - - PowerPoint PPT Presentation
Monthly Webinar Series January, 2019 Todays Agenda Announcements/Trial Updates Christina Grabarits This Months Top Enroller & Prize Winner! Christina Grabarits Breakthrough Diseases & Re-Randomizations Ellen Mowry & Scott
January, 2019
Announcements/Trial Updates
Christina Grabarits
This Month’s Top Enroller & Prize Winner!
Christina Grabarits
Breakthrough Diseases & Re-Randomizations
Ellen Mowry & Scott Newsome
Commitment Pledge Responses
Ellen Mowry & Scott Newsome
Christina Grabarits
Q & A
Team
CHRISTINA GRABARITS
We now have 29 sites activated and 64 patients enrolled!!! We need each activated site to screen at least 6 patients each month and enroll 3-4 each month so we can reach our goal of 900 enrolled by June 30, 2019! Thank you for your dedication to the trial and please reach out with questions! The Johns Hopkins Coordinating Center is here to support you!!!
Next in-person Study Advisory Committee (SAC) meeting will be held in Dallas, TX on February 27, 2019 from 1:30 – 5 pm, preceding the ACTRIMS meeting.
*AS OF FRIDAY, 12/28/18
*AS OF FRIDAY, 12/28/18
December Enrollments:
Site Randomizations
University of Washington 1 Norton Neurology Specialists 2 Christiana Care 1 University of Kansas Medical Center 2 University of Alabama at Birmingham 3 Johns Hopkins 3
Total this month 12
December’s Top Enroller:
University of Alabama at Birmingham
ELLEN M. MOWRY, M.D., M.C.R. ASSOCIATE PROFESSOR OF NEUROLOGY AND EPIDEMIOLOGY JOHNS HOPKINS UNIVERSITY SCOTT D. NEWSOME, D.O. ASSOCIATE PROFESSOR OF NEUROLOGY JOHNS HOPKINS UNIVERSITY
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isabil ilit ity progression. => => Will ill in inves estigate overall ll and with ithin str trata of
eople at t high igher ver ersus lo lower risk risk of
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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.
Enrollment within 6 months of 1st 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 1st attack, OR new lesions on MRI if a subsequent MRI is available already Enrollment > 6 months since 1st 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
1:1 randomization 1:1 randomization
High risk disability indicators Low risk disability indicators
allowable a discussion about change in therapy
therapy if excessive breakthrough has occurred
Original: >4 new T2 lesions (MRI)=1 point; 1 relapse=1 point; 2 relapses=2 points
Later re-classified for those who scored 1 point (based on activity from months 12-18) into:
End of Year 1: a Modified Rio Score of 2-3, or in “medium-high” risk subgroup End of Year 2: a) if prior Modified Rio Score was medium-low risk (at year 1); anything more than 1 additional T2 hyperintensity at year 2 MRI (or earlier in year 2 if a relapse occurs prior to the year-end visit) b) if Year 1 Modified Rio Score was 0, a Modified Rio Score of “medium-high” risk or greater Subsequent years will be treated in the same fashion. For example, at the end of year 3: a) if prior Modified Rio Score was medium-low (at year 2): anything more than 1 additional T2 hyperintensity by end of year 3 (or earlier in year 3 if a relapse occurs prior to the year-end visit) b) if Year 2 Modified Rio Score (at year 2) was 0, a Modified Rio Score of “medium-high” risk or greater
Perhaps the most critical MRI in terms of having it, and its timing. Why?
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-8 months: can serve as true reference MRI scan against which subsequent new lesions can be confirmed as
>8 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.
for a bit >6 months AFTER start date of DMT
High risk disability indicators Low risk disability indicators
High risk disability indicators Low risk disability indicators
breakthrough if they are changing therapy
after 6 months on THAT therapy, there is no more randomization
Traditional (First-line) Glatiramer acetate (Copaxone, Glatopa, other generics) Intramuscular interferon (Avonex) Subcutaneous interferon (Betaseron, Extavia, Rebif) Pegylated interferon (Plegridy) Teriflunomide (Aubagio) Dimethyl fumarate (Tecfidera) Fingolimod (Gilenya) Early Aggressive Alemtuzumab (Lemtrada) Ocrelizumab (Ocrevus) Rituximab (Rituxan) Natalizumab (Tysabri)
(Cladribine, if it becomes FDA-approved) *Should not utilize dosages that exceed the maximally approved dosage for MS (or, in the case of rituximab, than the maximally approved dosage for RA) *New FDA-approved therapies will be added to medication lists after consensus-based approach by Study Advisory Committee
discontinue therapies for reasons other than breakthrough disease (e.g. intolerance, adverse effect, desire to conceive) will be encouraged (except in the instance of trying to conceive or pregnancy itself, or when such treatment is otherwise contraindicated) to choose another therapy within the efficacy class to which the discontinued therapy belongs.
choice will be documented at baseline and at any point a switch is made.
ELLEN M. MOWRY, M.D., M.C.R. ASSOCIATE PROFESSOR OF NEUROLOGY AND EPIDEMIOLOGY JOHNS HOPKINS UNIVERSITY
SCOTT D. NEWSOME, D.O. ASSOCIATE PROFESSOR OF NEUROLOGY JOHNS HOPKINS UNIVERSITY
Activated sites as of 12/11/18 have received this commitment letter from the trial PIs at Johns Hopkins along with this commitment pledge Sign and send back your commitment pledge ASAP
Site Date Letter Sent to Site Date Signed Letter Received from Site Advanced Neurology Specialists 12-Dec-18 13-Dec-18 University of Maryland 12-Dec-18 13-Dec-18 New York University School of Medicine 12-Dec-18 14-Dec-18 University of Kansas Medical Center 12-Dec-18 17-Dec-18 University of South Florida Health 12-Dec-18 20-Dec-18 Columbia Presbyterian 11-Dec-18 21-Dec-18 University of Miami 12-Dec-18 21-Dec-18 Central Texas Neurology 12-Dec-18 14-Dec-18 University of Washington 11-Dec-18 14-Dec-18
Site Date Letter Sent to Site Date Signed Letter Received from Site
Baylor Scott & White Health 11-Dec-18 Mayo Clinic 11-Dec-18 Stony Brook University 11-Dec-18 University of California at San Francisco 11-Dec-18 University of Cincinnati 11-Dec-18 University of Louisville 11-Dec-18 University of Rochester 11-Dec-18 University of Vermont 11-Dec-18 Vanderbilt University Medical Center 11-Dec-18 Christiana Care 12-Dec-18 Neurology Specialists of Tidewater 12-Dec-18 Norton Neurology Services 12-Dec-18 Ohio Health 12-Dec-18 Swedish Medical Center 12-Dec-18 University of Alabama at Birmingham 12-Dec-18 University of Florida Gainesville 12-Dec-18 University of Utah 12-Dec-18
Please sign the commitment pledge, emailed to your site during the second week of December, to secure your dedication to this very important trial!
CHRISTINA GRABARITS
ELEVATION
Mount Everest Contenders
*Not fit to scale
89.3 88.9 65.6
46.0 40.5 92.9 47.2
35.4 53.8
32.5
Activated Sites
Rank Activated Sites Final Points
1 Christiana Care 134.5 2 Norton Neurology Specialists 130.9 3 Baylor Scott & White Health 120.3 4 Columbia Presbyterian 112.6 5 Central Texas Neurology Consultants 104.1 6 University of Cincinnati 102.5 7 Dignity Health Sacramento 93.0 8 Advanced Neurology Specialists 85.3 9 New York University School of Medicine 85.2 10 University of Maryland 82.7
Mount Everest Standings
CHRISTINA GRABARITS
West Midwest South Northeast Team A Team B Team C Team D Team E Team F Team G Team H
Advanced Neurology Specialists University of California at San Francisco Mayo Clinic Baylor Scott & White Health University of Louisville Christiana Care New York University School of Medicine University of Vermont Swedish Medical Center University of Washington University of Cincinnati University of Kansas Medical Center Norton Neurology Services Vanderbilt University Medical Center Stony Brook University Columbia Presbyterian University of Utah Dignity Health Sacramento Ohio Health University of Michigan University of Florida, Gainesville University of Alabama at Birmingham University of Rochester Geisinger Clinic Billings Clinic Barrow Neurological Institute Oklahoma Medical Research Foundation Wayne State University University of South Florida Health University of Maryland Icahn School of Medicine Massachusetts General Hospital Providence Health University of California Los Angeles Rush University Medical Center University of Miami Neurology Specialists of Tidewater Barnabas Multiple Sclerosis Comp. Care Center University of Massachusetts Worcester Cedars Sinai University of California San Diego Central Texas Neurology Consultants Georgetown University Hackensack University Medical Center Allegheny Health Network
Assigned teams
Northeast Team H U Vermont Columbia Presbyterian Northeast Team G U of Rochester Stony Brook NYU West Team B UCSF U of Washington
Points
Specialists 67
52
51
44
41
38
32
28
21
14
JHU Midwest Team D Baylor Scott & White Health KUMC U of Louisville Norton UFL Gainesville South Team E CentralTx Neuro U of Miami U of South Florida Health Midwest Team C U Cinn Mayo Clinic Ohio Health West Team A Swedish Advanced Neuro Spc U of Utah South Team F UAB U of Maryland Christiana Care Vanderbilt Neuro Spc of Tidewater
Rowing Competition
https://treat.preludedynamics.com
Join us tomorrow for the encore performance! January 3rd @ 8 AM EST
February’s Monthly Webinar will be held on the 6th at 3pm and 7th at 9am Eastern