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Safety of Therapeutic Step-down in Neuromyelitis Optica

Safety of Therapeutic Step-down in Neuromyelitis Optica

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05155644
Acronym
NMO
Enrollment
947
Registered
2021-12-13
Start date
2020-08-01
Completion date
2021-12-31
Last updated
2022-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromyelitis Optica

Keywords

Neuromyelitis Optica, NMO, multiple sclerosis (MS), Iatrogeny., Autoimmune diseases

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.

Interventions

None listed

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frame
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]

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026