The safety and cost-effectiveness of discontinuing disease-modifying therapies in relapsing-onset multiple sclerosis (DOT-MS): a randomized rater-blinded multicenter trial.

Amsterdam UMC, location VUmc0 个研究点目标入组 130 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•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

•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.

发起方

Amsterdam UMC, location VUmc