Safety of Therapeutic Step-down in Neuromyelitis Optica (NMO)

January 20, 2022 updated by: University Hospital, Strasbourg, France
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

947

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67091
        • Service de neurologie - Hôpitaux Universitaires de Strasbourg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Jérôme DE SÈZE, MD, PhD, Service de neurologie - Hôpitaux Universitaires de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Actual)

November 30, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

October 7, 2021

First Submitted That Met QC Criteria

December 9, 2021

First Posted (Actual)

December 13, 2021

Study Record Updates

Last Update Posted (Actual)

January 21, 2022

Last Update Submitted That Met QC Criteria

January 20, 2022

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7808 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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