Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS)



Status:Recruiting
Conditions:Neurology, Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:55 - Any
Updated:2/27/2019
Start Date:April 20, 2017
End Date:February 2021
Contact:Eric Engebretson, BA
Email:eric.engebretson@ucdenver.edu
Phone:303-724-8388

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Natural history research in Multiple Sclerosis (MS) suggests that risk of relapses and new
Magnetic Resonance Imaging (MRI) changes diminish significantly as people age, especially in
MS patients 55 or older. Thus, the need to continue MS medicines that reduce relapses and new
MRI lesions may also decrease as people age, especially in those who have not had relapses or
MRI scan changes for prolonged times. This study plans to learn more about the safety of
stopping MS medication in this population, as compared to continuing on the medication.

This study will have 2 different groups of research subjects. One of these groups will stay
on their current MS medication, and one group will discontinue their medication. To decide
which group the participant will be in, the investigators will use a method of chance. This
method is like flipping a coin or rolling dice. This is called "randomization".

Participants will be randomized to one of the 2 groups as described above. They will also
have some extra assessments done at their regular routine MS clinic appointment and every 6
months for the next 2 years. The following items will be done in addition to any assessments
or procedures they are already having done as part of their clinical care and are the only
items to be paid for by the study:

- Some questionnaires about the participant's quality of life including questions about
health, mood, thinking, and social life

- Some questionnaires about the participant's MS symptoms

- A test of the participant's attention, concentration, and thinking that involves adding
and repeating numbers

- A test of the participant's physical symptoms

- Along with the MRIs the participants get as part of their routine care, they will also
have one 6 months from their start in the study as part of the study.

Inclusion Criteria:

- Patients with either Relapsing-remitting MS (RRMS), Secondary progressive MS (SPMS),
or Primary progressive MS (PPMS) by McDonald 2010 criteria.

- Patients defined by subtype based on 2013 updated phenotypic criteria.

- Progression of MS defined by the local PI either:

- prospectively with an EDSS change of at least 1.0 points over the last two years,
or

- retrospectively, with any significant change in motor function over at least one
year, unrelated to relapse.

- 55 years of age or older at time of randomization;

- No evidence of recent new inflammatory disease activity (inactive by the Lublin
criteria16) with no new relapse for at least five years and no new MRI lesion for at
least three years

- Using any of the FDA-approved MS DMTs (to include:

- interferon β-1a,

- interferon β-1b,

- glatiramer acetate,

- natalizumab,

- fingolimod,

- dimethyl fumarate, or

- teriflunomide; continuously for no less than 5 years.

- Taking most recent DMT continuously* for no less than two years.

- Willing to be randomized per this protocol; each patient will be questioned as to
their willingness to stay in the trial regardless of the group to which group they are
randomized.

- Willing to follow the protocol

- Able to undergo a brain MRI without anesthesia

- Continuously will be defined as no less than 75% of all prescribed doses, with no
time of greater than four weeks from last intended dose to have missed a dose (8
weeks for natalizumab, i.e. one missed dose).

Exclusion Criteria:

- Any MS relapse in the last five years, as determined at the screen visit by the PI

- Any new or definitely enlarging T2/FLAIR lesion or new gadolinium-enhancing lesion
within the past three years (at least two scans separated by at least three years must
be reviewed) on brain or spine MRI scan. Lesions must be 3mm or larger to be
exclusionary.

- Significant (as defined by the PI) intolerance of presently-used DMT

- More than two courses of acute, systemic (IV or oral) steroids in the last 5 years or
any use within the last year. Course is defined as three or more days continuously,
and not to exceed 14 days. No use of chronic, systemic steroids, defined as 15 or more
days, in the last 5 years. Any use of steroids to treat MS relapse, possible relapse,
or pseudo-relapse in the last 5 years.

- Use of inhaled or topical steroids are not an exclusion criteria.

- Use of oral steroids for no greater than 14 days given for a non-MS condition is
not exclusionary.

- Prior use of the following in the past 5 years:

- alemtuzumab,

- mitoxantrone,

- cyclophosphamide,

- methotrexate,

- cyclosporine, or

- rituximab

- Prior use of any experimental agent used as a DMT for MS in the last five years

- Other significant medical or psychiatric illness, if uncontrolled. Examples:

- uncontrolled hypertension,

- uncontrolled diabetes,

- uncontrolled asthma, or

- uncontrolled depression

- Cancers other than basal cell skin cancers within the last 5 years

- Unable to give informed consent or follow the protocol

- Unable to undergo brain MRI

- Unwilling to be randomized per this protocol

- History of other chronic neurological illnesses that might mimic MS with chronic or
intermittent symptoms (i.e. ALS, myasthenia gravis, chronic neuropathy, etc.)
We found this trial at
16
sites
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Phone: 216-444-5441
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Miami, Florida 33124
(305) 284-2211
Phone: 305-243-1088
University of Miami A private research university with more than 15,000 students from around the...
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Phone: 412-624-9126
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Phone: 503-494-3549
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Phone: 585-275-6120
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Aurora, Colorado 80045
Phone: 303-724-4644
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Charlottesville, Virginia 22903
(434) 924-0311
Phone: 434-924-5717
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Phone: 614-293-7877
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Phone: 615-322-4322
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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New York, New York 10016
Phone: 646-501-7534
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1468 Madison Avenue
New York, New York 10029
Phone: 212-241-3841
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Phone: 215-662-4893
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Phone: 215-955-9575
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Saint Louis, Missouri 63110
Phone: 314-362-3402
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3700 O St NW
Washington, District of Columbia 20057
(202) 687-0100
Phone: 202-444-1447
Georgetown University Georgetown University is one of the world's leading academic and research institutions, offering...
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