Neuromyelitis OpticaNMONCT05155644
Safety of Therapeutic Step-down in Neuromyelitis Optica
An observational study of Neuromyelitis Optica, run by University Hospital, Strasbourg, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromyelitis Optica
- How many people
- 947 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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)
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Neurologie - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
About this study
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
- Medical subject headings
- Neuromyelitis Optica, Multiple Sclerosis, Autoimmune Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective evaluation of the risk of rebound during therapeutic escalations in neuromyelitis optica (NMO)
Measured: Files analysed retrospectively from January 01, 2000 to December 31, 2020 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start1 Aug 2020
- Primary completion30 Nov 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromyelitis OpticaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 947 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérôme DE SÈZE, MD, PhD, Principal investigator, Service de Neurologie - Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155644
- Sponsor's protocol ID
- 7808
- Acronym
- NMO
- Status last verified
- Oct 2021
- First submitted
- 7 Oct 2021
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Therapeutic Step-down in Neuromyelitis Optica
- ClinicalTrials.gov ID
- NCT05155644
- Acronym / sponsor ID
- NMO / 7808
- Conditions
- Neuromyelitis Optica
- Keywords
- Neuromyelitis Optica, NMO, multiple sclerosis (MS), Iatrogeny., Autoimmune diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 947 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 13 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jérôme DE SÈZE, MD, PhD principal investigator
Service de Neurologie - Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromyelitis Optica, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2022.