The French Cohort and Biobank of Devic's Neuromyelitis Optica and Related Neurological Disorders (NMOSD) (NOMADMUS)

NCT ID: NCT02850705

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1787 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2021-11-30

Brief Summary

Devic's neuromyelitis optica (NMO) is rare. Epidemiological and demographic data are poor, based mainly on monocentric cohorts. Moreover, NMO might be difficult to distinguish from multiple sclerosis and begin with atypical or incomplete clinical presentations. Therefore, NMO is still underdiagnosed. The constitution of a nationwide and prospective cohort, including not only NMO but also clinical syndromes suggestive of a first episode (DNMO-spectrum disorders (SDs)), should allow to gather a critical mass of cases and answer questions that could not have been addressed at the level of a single centre.

Objectives: The main objective is to describe the clinical, radiological and biological features of NMO spectrum disorder (NMO, isolated longitudinally extensive transverse myelitis (LETM), relapsing or not; isolated atypical optic neuritis (ON)) and their evolution. The second aim is to create a biobank dedicated to NMO (serum, whole blood for RNA and DNA extraction, cerebrospinal fluid), to promote translational research in the field. Methods: NOMADMUS is a prospective, multicentre, observational study of patients NMOSD and related disorder in France. Prevalent cases are included retrospectively and then followed prospectively. Incident cases are included from disease onset and followed prospectively. A minimal set of data has been defined and synthesized on specific paper forms derived from the European database for multiple sclerosis (EDMUS) forms. Patients are systematically tested regarding their AQP4-IgG and MOG-IgG status. All the data are centralised in a EDMUS-derived database in Lyon, the EDEN software. All cases are validated and classified by an expert committee.

Conditions

Neuromyelitis Optica Spectrum Disorders; Neuromyelitis Optica Spectrum Related Disorders

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

Definite Devic's Neuromyelitis Optica NMO according to established criteria (Wingerchuk 1999, Wingerchuk 2006, International panel 2015)

• high risk syndromes for NMOSD, defined as: recurrent or simultaneous optic neuritis, idiopathic single or recurrent longitudinally extensive transverse myelitis (spinal cord lesion seen on MRI >3 vertebral segments)
• patients tested positive for AQP4-IgG autoantibody or MOG-IgG autoantibody
• living in France since 5 years minimum

Exclusion Criteria

• None

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospices Civils de Lyon / Hopital Neurologique Pierre Wertheimer

Bron, , France

Countries

France

References

Januel E, Brochard V, Le Guennec L, Maillart E, Louapre C, Lubetzki C, Weiss N, Demeret S, Papeix C. Risk factors and prognosis of orotracheal intubation in aquaporin-4-IgG neuromyelitis optica spectrum disorder attacks. Ann Intensive Care. 2024 Jan 8;14(1):4. doi: 10.1186/s13613-023-01213-x.

Reference Type: DERIVED

PMID: 38185760 (View on PubMed)

Demuth S, Collongues N, Audoin B, Ayrignac X, Bourre B, Ciron J, Cohen M, Deschamps R, Durand-Dubief F, Maillart E, Papeix C, Ruet A, Zephir H, Marignier R, De Seze J; NOMADMUS Study Group. Rituximab De-escalation in Patients With Neuromyelitis Optica Spectrum Disorder. Neurology. 2023 Jul 25;101(4):e438-e450. doi: 10.1212/WNL.0000000000207443. Epub 2023 Jun 8.

Reference Type: DERIVED

PMID: 37290967 (View on PubMed)

Other Identifiers

D50742

Identifier Type: -

Identifier Source: org_study_id