multiple sclerosis
Conditions
Interventions
 
The intervention is the discontinuation of previously used disease-modifying 
therapy (DMT). 
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Patients who are treated with one of the first-line treatments (any of the interferons, glatiramer acetate, dimethylfumarate, teriflunomide) and who had a complete absence of inflammatory activity (no relapses, no new-T2 lesions and no contrast-enhancing lesions on MRI) for 5 consecutive years under first-line treatment will be eligible for inclusion. In case the last available MRI-scan was conducted 10 or more years ago, no more than 3 new T2-lesions in these 10 years are accepted.
Exclusion criteria
Exclusion criteria: - Clinical or radiological inflammatory disease activity in the 5 years prior to the study. - A switch between first-line disease modifying therapy over two years prior to inclusion, in case the switch has been due to in effectivity of the first DMT. In case the switch has been due to side-effects or by a personal preference of the patient (such as the wish to switch to oral therapies), this is not considered as an exclusion criterium. - Women who want to discontinue medication because of a pregnancy wish and women who are pregnant or expect to become pregnant during the study period - Patients that have previously used interferon-beta and have been tested positive for neutralizing antibodies (NAbs).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is number of patients with return of inflammatory disease activity after 2 years based on: a clinically confirmed relapse (defined according to the definition most often used in MS phase-III trials: the onset of new or recurrent symptoms that last > 24 hours, that are accompanied by new objective abnormalities on a neurological examination and that are not explained by non-MS processes such as fever, infection, severe stress or drug toxicity (Gold et al NEJM 2012)) , or any emerging subclinical disease activity proven to be due to active disease/new inflammation (defined as 3 or more lesions on T2*weighted images or 2 or more gadolinium enhancing lesions on T1-weighted post-contrast MRI suggestive of demyelination) in the discontinuation group. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Changes in neurological functioning: EDSS-change, MSFC-change (timed 25-foot walk test, 9-hole peg test, symbol digits modality test) - Individual MRI-parameters: T1 post-contrast lesion numbers, T2 lesion numbers, atrophy measurements. - Changes in quality of life measurements: MSIS-29, short form health survey (SF-36), CIS20r, MSSE, Treatment Satisfaction Questionnaire for Medication (TSQM), EQ5D-5L, iMCQ, iPCQ. - Changes in biomarker measurements (neurofilament light). - OCT and eye movement measurements: peri-papillary retinal nerve fiber (RNFL) thickness, macular ganglion cell-layer inner plexiform layer (GCL-IPL) thickness, eye movement measurements - Changes in digital biomarkers using the NeuroKeys and MS sherpa mobile applications: 2-minute walking test, cognition test, questionnaire, keystroke data. | — |
Countries
Netherlands
Contacts
Public ContactJ. Killestein
Amsterdam UMC
Outcome results
None listed