Trials / Unknown

UnknownNCT04260711

Discontinuing Disease-modifying Therapies in Stable Relapsing - Onset Multiple Sclerosis (DOT-MS).

The Safety and Cost-effectiveness of Discontinuing Disease-modifying Therapies in Stable Relapsing - Onset Multiple Sclerosis (DOT-MS): a Randomized Rater-blinded Multicenter Trial.

Status: Unknown
Phase: N/A
Study type: Interventional
Enrollment: 130 (estimated)

Sponsor: Amsterdam UMC, location VUmc · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

The aim of this study is to identify whether it is possible to safely discontinue treatment in relapsing-onset MS patients who have shown no evidence of active inflammation in the years prior to inclusion clinically and/or radiologically. The secondary objectives address the questions whether the discontinuation of first-line treatment has an effect on disability progression and whether the discontinuation of first-line treatment improves the quality of life for the patient. Furthermore, blood collections will be included to assess whether it is possible to retrospectively predict possible return of inflammatory activity with biomarkers such as neurofilament light (NFL) or patient characteristics such as disease activity prior to disease modifying therapy (DMT). In case of emerging disease activity after the cessation of therapy we will assess if reinitiation will lead to NEDA again, and if there are long-term consequences. If possible, post-hoc analysis are performed for the different types of treatment compounds.

Conditions

Interventions

Type	Name	Description
DRUG	DMT	Discontinuation of patients' own disease modifying therapy (any of the interferons, glatiramer acetate, dimethylfumarate, teriflunomide)

Timeline

Start date: 2020-07-01
Primary completion: 2023-08-01
Completion: 2024-01-01
First posted: 2020-02-07
Last updated: 2020-10-19

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT04260711. Inclusion in this directory is not an endorsement.