The Italian Multiple Sclerosis and Related Disorders Register (RISM)

Registro Italiano Sclerosi Multipla e Patologie Correlate

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Multiple Sclerosis; Clinically Isolated Syndrome; Neuromyelitis Optica; Radiologically Isolated Syndrome; Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease; Demyelinating Diseases of the Central Nervous System

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 96000

Contacts and Locations

Study Locations

• Italy
  • Genova
    • Genova, Genova, Italy, 16149
      • Fondazione Italiana Sclerosi Multipla (FISM ETS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All the Italian clinical centers specialized in multiple sclerosis and related disorders who participate in RISM invite their patients to be part of the study. Only subjects with multiple sclerosis (including CIS and RIS), NMOSD or MOGAD are enrolled in RISM.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Multiple Sclerosis (MS)
Neuromyelitis Optica Spectrum Disorders (NMOSD)
Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of cases included	Total number of subjects with multiple sclerosis and related disorders (NMOSD and MOGAD) included in the study.	1 year
Description of demographic characteristics	Female/male ratio.	1 year
Description of demographic characteristics	Distributions of age at onset in years.	1 year
Description of demographic characteristics	Interval between onset and diagnosis dates in years.	1 year
Expanded Disability Status Scale (EDSS)	Number of EDSS scores collected every 6 and 12 months by each center.	1 year
Disease-modifying treatment description	Distribution of patients with/without a DMT prescription.	1 year
Disease-modifying treatment description	Interval between diagnosis and first DMT start dates in years.	1 year
Disease-modifying treatment description	Frequencies of first and last DMT.	1 year
Magnetic Resonance Imaging (MRI)	Number of MRI exams collected every year by each center.	1 year

Collaborators and Investigators

• Sponsor: Fondazione Italiana Sclerosi Multipla
• Collaborators: University of Bari Aldo Moro

Publications and helpful links

General Publications

• Ponzio M, Battaglia MA, Trojano M, Salivetto M, D'Ettorre A, Corrado D, Paletta P, Lepore V, Mosconi P; Comitato Scientifico del Registro Italiano Sclerosi Multipla e Patologie Correlate; Rete dei centri del Registro Italiano Sclerosi Multipla e Patologie Correlate; Rete degli assistenti di ricerca del Registro Italiano Sclerosi Multipla e Patologie Correlate. [Registers as central real world data source: the experience of the Italian Multiple Sclerosis and Related Disorders Register]. Epidemiol Prev. 2024 Jul-Oct;48(4-5):361-374. doi: 10.19191/EP24.4-5.A734.074. Italian.
• Trojano M, Bergamaschi R, Amato MP, Comi G, Ghezzi A, Lepore V, Marrosu MG, Mosconi P, Patti F, Ponzio M, Zaratin P, Battaglia MA; Italian Multiple Sclerosis Register Centers Group. The Italian multiple sclerosis register. Neurol Sci. 2019 Jan;40(1):155-165. doi: 10.1007/s10072-018-3610-0. Epub 2018 Nov 13.
• Mosconi P, Guerra T, Paletta P, D'Ettorre A, Ponzio M, Battaglia MA, Amato MP, Bergamaschi R, Capobianco M, Comi G, Gasperini C, Patti F, Pugliatti M, Ulivelli M, Trojano M, Lepore V; Italian Multiple Sclerosis and Related Disorders Register Centres Group. Data monitoring roadmap. The experience of the Italian Multiple Sclerosis and Related Disorders Register. Neurol Sci. 2023 Nov;44(11):4001-4011. doi: 10.1007/s10072-023-06876-9. Epub 2023 Jun 14.

Helpful Links

• Public website of the Italian Multiple Sclerosis and Related Disorders Register

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2014
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: June 5, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Epidemiology; Autoimmune Diseases; Disease Registry; Pharmacoepidemiology; Patient Registry; Real-World Evidence; Real-World Data; Disease Modifying Treatment
• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Eye Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Myelitis, Transverse; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Multiple Sclerosis; Neuromyelitis Optica; Autoimmune Diseases; Demyelinating Diseases; Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease
• Other Study ID Numbers: RISM - FISM 2015/S/1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No