Safety of Therapeutic Step-down in Neuromyelitis Optica

Neuromyelitis Optica Clinical Trial

— NMO  

Official title:

Safety of Therapeutic Step-down in Neuromyelitis Optica

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05155644
• Other study ID #: 7808
• Status: Completed
• Start date: August 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2021
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 947
• Est. completion date: December 31, 2021
• Est. primary completion date: November 30, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuromyelitis Optica

Locations

Country	Name	City	State
France	Service de Neurologie - Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]