The Italian Multiple Sclerosis and Related Disorders Register

NCT07636876 | Enrolling By Invitation

• 1 other identifier: RISM - FISM 2015/S/1
• Study Type: observational
• Target: 96,000
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Neuromyelitis Optica; Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease; Demyelinating Diseases of the Central Nervous System; Multiple Sclerosis; Clinically Isolated Syndrome; Radiologically Isolated Syndrome

Keywords

Epidemiology; Pharmacoepidemiology; Disease Registry; Patient Registry; Disease Modifying Treatment; Autoimmune Diseases; Multiple Sclerosis; Real-World Data; Real-World Evidence

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (3)

Multiple Sclerosis (MS)

Neuromyelitis Optica Spectrum Disorders (NMOSD)

Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Fondazione Italiana Sclerosi Multipla: lead
• University of Bari Aldo Moro: collaborator

Study Sites (1)

Fondazione Italiana Sclerosi Multipla (FISM ETS)

Genova, Genova, 16149, Italy

Location

Related Publications (3)

• 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.

  PMID: 39329242 RESULT

• 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.

  PMID: 30426289 RESULT

• 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.

  PMID: 37311951 RESULT

Related Links

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

MeSH Terms

Conditions

Multiple Sclerosis; Neuromyelitis Optica; Demyelinating Diseases; Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Immune System Diseases; Myelitis, Transverse; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: June 9, 2026
• Study Start: September 17, 2014
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 9, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)