Multiple Sclerosis
Conditions
Interventions
Discontinuation of disease-modifying treatment
Sponsors
Amsterdam UMC, location VUmc
Eligibility
Inclusion criteria
Inclusion criteria: 1. A minimum age of 18 years 2. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local privacy regulations. 3. Definite diagnosis of relapsing-onset MS according to the revised McDonald 2017 criteria 4. All relapsing-onset MS patients treated with one of the first-line treatments: any of the interferons, glatiramer acetate, dimethylfumarate, teriflunomide 5. Complete absence of inflammatory activity (no objectively defined and confirmed relapses, no significant number (2 or more) of new-T2 lesions and no contrast-enhancing lesions) for 5 consecutive years under first-line treatment
Exclusion criteria
Exclusion criteria: 1. 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. 2. 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 3. Patients that have previously used interferon-beta and have been tested positive for neutralizing antibodies (NAbs). This is determined by measuring MxA-bioactivity and is a test that is part of routine follow-up in patients that use interferon-beta. The reason for this is that development of NAbs has been shown to affect interferon-beta treatment efficacy.
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) in the discontinuation group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end points are: - Changes in neurological functioning (EDSS, MSFC) - Individual MRI-parameters (T1-post contrast lesion numbers and volumes, T2-lesion numbers and volumes, atrophy measurements) | — |
Contacts
Public ContactEline Coerver
Amsterdam UMC, locatie VUmc
Outcome results
None listed