Safety of Therapeutic Step-down in Neuromyelitis Optica

Neuromyelitis Optica (NMO) is a neuroinflammatory disease related to multiple sclerosis (MS). It affects young subjects and causes a lot of handicap without treatment. Thus, aggressive treatments are frequently introduced early in the life of patients and maintained over the long term. A long duration of treatment exposes to iatrogenism. Therapeutic de-escalation trials in MS or other autoimmune diseases show rebound phenomena. In the NMO, there are no published data on the tolerance of desescalations to guide such strategies.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neuromyelitis Optica Autoimmune Diseases Autoimmune Diseases of the Nervous System Cranial Nerve Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Eye Diseases Immune System Diseases Multiple Sclerosis Myelitis, Transverse Nervous System Diseases Optic Nerve Diseases Optic Neuritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Neurologie - Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Major patients who have received long-term treatment for NMO
Patients with a prospectively diagnosed NMO using the 2015 NMO classification criteria (IPND)
Patients who retrospectively meet the classification criteria of the 2015 NMO (IPND)
Patients who have not expressed their opposition, after information, to the reuse of their data for research purposes.

Exclusion criteria

Patient who expressed his opposition to participating in the study
Lack of data on the assay of anti-AQP4 and anti-MOG antibodies
Less than a year of taking a second-line treatment before the relay
End of follow-up <1 year following the transfer, this therefore includes patients whose transfer took place less than one year before the date of data extraction

Treatment and study plan

Primary outcomes

Retrospective evaluation of the risk of rebound during therapeutic escalations in neuromyelitis optica (NMO)

Time frame: Files analysed retrospectively from January 01, 2000 to December 31, 2020 will be examined]

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: NMO

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Dec 13, 2021
Registry last updated: Jan 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Enrolling by Invitation