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Enrolling by Invitation

NCT Number: NCT07636876

The Italian Multiple Sclerosis and Related Disorders Register

The Italian Multiple Sclerosis and Related Disorders Register (Registro Italiano Sclerosi Multipla e Patologie Correlate - RISM) is an observational cohort study that aims to create an organised multicentre structure to collect data of all patients with multiple sclerosis (MS) followed in the various MS clinical centers in Italy (a near population-level).

RISM is promoted and funded by the Italian Multiple Sclerosis Foundation (Fondazione Italiana Sclerosi Multipla - FISM ETS). In 2014, FISM and the University of Bari constituted a "Research Unit", which manages the project and acts on behalf of the participating MS clinical centers. The governance of RISM includes an Executive Committee (chaired by FISM and the University of Bari) with administrative and organisational roles and a Scientific Committee, which oversees the scientific initiatives, promotes specific strategic projects, and approves requests for access to centralised data for further research projects.

RISM aims to address high-priority research areas pertaining to: public healthcare area (quality of care, health optimisation such as economic optimisation, social and welfare information, access to healthcare treatments and healthcare services) and research area (epidemiology, rare MS disease forms such as primary progressive MS, pediatric MS as well as early and preclinical/subclinical disease stages represented by clinically isolated syndromes and radiologically isolated syndromes, treatment optimisation such as prognostic factors and predictive models of disease course, adherence to treatments, treatment efficacy, and safety).

RISM also includes patients with Neuromyelitis Optica Spectrum Disorders (NMOSD) and Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD).

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Clinically Isolated Syndrome Cranial Nerve Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Demyelinating Diseases of the Central Nervous System Eye Diseases Immune System Diseases Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease Myelitis, Transverse Nervous System Diseases Neuromyelitis Optica Optic Nerve Diseases Optic Neuritis Radiologically Isolated Syndrome

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Italiana Sclerosi Multipla (FISM ETS)

Genova, 16149, Italy

About this study

In 2000, the Italian collection of MS clinical data started at different Italian MS centres in the framework of the Italian Multiple Sclerosis Database Network (MSDN). At the end of 2014, the Italian Multiple Sclerosis and Related Disorders Register (RISM) was set up to create a national data source collecting demographic and clinical data on people with multiple sclerosis. Currently, data are collected through a web-based system - the RISM-App - developed ad hoc for the study. Each centre can enter the data after identification through a personalised password. In RISM, each patient is assigned to a specific centre and has a unique valid code identifier, obtained through the patient encrypted fiscal code.

The RISM-App includes 1,475 variables and is organised into sections and subsections. According to the current clinical practice, the following information is requested in the RISM-App: identification/personal data, onset and diagnosis (anamnesis), follow-up visits (EDSS, safety, and relapses), adverse events (clinical events), treatments, non-pharmacological treatments, risk assessment, pregnancies, COVID-19, co-morbidity, familiar anamnesis, tests and scales, laboratory exams, magnetic resonance, liquor, evoked potentials, EEG, ECG, blood pressure, eye examination, optical computerised tomography.

To harmonise data collection, the RISM-App integrates several standardised databases, including FarmaDati, MedDRA, ICD-9-CM, and EUROCAT (for congenital anomalies). Continuous data monitoring is ensured through regular communication with centres, biannual ad hoc reports providing both overall and centre-specific quality and descriptive indicators, data verification requests, and training on standardised data collection procedures. In addition, a set of built-in validation checks - such as consistency between date of birth, diagnosis, first visit, and treatment - is implemented in the RISM-App to prevent conflicting entries.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of definite or probable multiple sclerosis
  • Clinical diagnosis of CIS or RIS
  • Clinical diagnosis of NMOSD or MOGAD
  • Patient is able to understand and sign the informed consent to participate in the study

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Number of cases included

    Time frame: 1 year

    Total number of subjects with multiple sclerosis and related disorders (NMOSD and MOGAD) included in the study.

  2. Description of demographic characteristics

    Time frame: 1 year

    Female/male ratio.

  3. Description of demographic characteristics

    Time frame: 1 year

    Distributions of age at onset in years.

  4. Description of demographic characteristics

    Time frame: 1 year

    Interval between onset and diagnosis dates in years.

  5. Expanded Disability Status Scale (EDSS)

    Time frame: 1 year

    Number of EDSS scores collected every 6 and 12 months by each center.

  6. Disease-modifying treatment description

    Time frame: 1 year

    Distribution of patients with/without a DMT prescription.

  7. Disease-modifying treatment description

    Time frame: 1 year

    Interval between diagnosis and first DMT start dates in years.

  8. Disease-modifying treatment description

    Time frame: 1 year

    Frequencies of first and last DMT.

  9. Magnetic Resonance Imaging (MRI)

    Time frame: 1 year

    Number of MRI exams collected every year by each center.

Sponsors and collaborators

Lead sponsor

Fondazione Italiana Sclerosi Multipla

Other

Collaborators

  • University of Bari Aldo Moro

Registry information

Official study title

Registro Italiano Sclerosi Multipla e Patologie Correlate

Acronym: RISM

Important dates

Study start
2014
Primary completion
2026
Study completion
2026
First posted
Jun 9, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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