Safety of Therapeutic Step-down in Neuromyelitis Optica

Completed

• Conditions: Neuromyelitis Optica

• Registration Number: NCT05155644
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

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

Not available

Study Timeline

• Study Start: 2020-08-01
• Status Verified: 2021-10
• Study First Submitted: 2021-10-07
• Primary Completion: 2021-11-30
• Study First Submitted QC: 2021-12-09
• Study First Posted: 2021-12-13
• Study Completion: 2021-12-31
• Last Update Submitted: 2022-01-20
• Last Update Posted: 2022-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 947

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Retrospective evaluation of the risk of rebound during therapeutic escalations in neuromyelitis optica (NMO)	Files analysed retrospectively from January 01, 2000 to December 31, 2020 will be examined]

Trial Locations

Locations (1)

Service de Neurologie - Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France