Safety of Therapeutic Step-down in Neuromyelitis Optica

NCT ID: NCT05155644

Last Updated: 2022-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

947 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Neuromyelitis Optica

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jérôme DE SÈZE, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Service de Neurologie - Hôpitaux Universitaires de Strasbourg

Locations

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Service de Neurologie - Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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7808

Identifier Type: -

Identifier Source: org_study_id

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