Safety of Therapeutic Step-down in Neuromyelitis Optica

NCT05155644 | Completed

• 1 other identifier: 7808
• Study Type: observational
• Target: 947
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuromyelitis Optica

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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]

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Major patients who have received long-term treatment for NMO and with a prospectively diagnosed NMO using the 2015 NMO classification criteria (IPND)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de Neurologie - Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Neuromyelitis Optica; Multiple Sclerosis; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Demyelinating Diseases; Eye Diseases; Immune System Diseases

Study Officials

• Jérôme DE SÈZE, MD, PhD

  Service de Neurologie - Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: December 13, 2021
• Study Start: August 1, 2020
• Primary Completion: November 30, 2021
• Study Completion: December 31, 2021
• Last Updated: January 21, 2022

Record last verified: 2021-10

Locations

FR (1)