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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 1 March 2021
Main ID:  NCT03073603
Date of registration: 18/01/2017
Prospective Registration: Yes
Primary sponsor: University of Colorado, Denver
Public title: Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS) DISCOMS
Scientific title: Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS)
Date of first enrolment: April 20, 2017
Target sample size: 260
Recruitment status: Active, not recruiting
URL:  https://clinicaltrials.gov/show/NCT03073603
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).  
Phase:  Phase 4
Countries of recruitment
United States
Contacts
Name:     John Corboy, MD
Address: 
Telephone:
Email:
Affiliation:  University of Colorado, Denver
Key inclusion & exclusion criteria

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 ß-1a,

- interferon ß-1b,

- glatiramer acetate,

- natalizumab,

- fingolimod,

- dimethyl fumarate,

- ocrelizumab, 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,

- rituximab,

- siponimod, or

- cladribine

- 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.)



Age minimum: 55 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Multiple Sclerosis
Intervention(s)
Drug: Discontinuation of disease modifying therapy
Drug: Standard of Care
Primary Outcome(s)
Number of patients with new disease activity upon discontinuation of therapy vs. those continuing therapy. [Time Frame: Baseline, then every 6 months for 2 years with one exception at 18 months.]
Secondary Outcome(s)
Evaluation of Change in Physical Disability using the Expanded Disability Status Scale (EDSS) [Time Frame: Baseline, then every 6 months for 2 years.]
Evaluation of the patient's Quality of Life using the MSIS-29 Scale [Time Frame: Baseline, then every 6 months for 2 years.]
Total Number of New T2 Lesions on MRI [Time Frame: Baseline, then every 6 months for 2 years with one exception at 18 months.]
Secondary ID(s)
15-2388
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Multiple Sclerosis Society
Patient-Centered Outcomes Research Institute
University of Alabama at Birmingham
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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