Multiple SclerosisRISMNCT07636876
The Italian Multiple Sclerosis and Related Disorders Register
An observational study of Multiple Sclerosis and Neuromyelitis Optica, run by Fondazione Italiana Sclerosi Multipla at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis, Neuromyelitis Optica, Demyelinating Diseases of the Central Nervous System
- How many people
- 96,000 participants
- Where
- 1 siteItaly
- Study dates
- 17 Sep 2014to Jul 2026
- How long will I take part?
- 7 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione Italiana Sclerosi Multipla (FISM ETS)
Genova, Genova, 16149
About this study
Official title: 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.
Read more
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).
Read the 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.
- Conditions
- Multiple Sclerosis, Neuromyelitis Optica, Demyelinating Diseases of the Central Nervous System, Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease, 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
- Medical subject headings
- Multiple Sclerosis, Neuromyelitis Optica, Demyelinating Diseases, Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Multiple Sclerosis (MS) | Not described | |
| Neuromyelitis Optica Spectrum Disorders (NMOSD) | Not described | |
| Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cases included
Total number of subjects with multiple sclerosis and related disorders (NMOSD and MOGAD) included in the study.
Measured: 1 year
Description of demographic characteristics
Female/male ratio.
Measured: 1 year
Description of demographic characteristics
Distributions of age at onset in years.
Measured: 1 year
Description of demographic characteristics
Interval between onset and diagnosis dates in years.
Measured: 1 year
Expanded Disability Status Scale (EDSS)
Number of EDSS scores collected every 6 and 12 months by each center.
Measured: 1 year
Disease-modifying treatment description
Distribution of patients with/without a DMT prescription.
Measured: 1 year
Disease-modifying treatment description
Interval between diagnosis and first DMT start dates in years.
Measured: 1 year
Disease-modifying treatment description
Frequencies of first and last DMT.
Measured: 1 year
Magnetic Resonance Imaging (MRI)
Number of MRI exams collected every year by each center.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start17 Sep 2014
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96,000 participants (estimated)
- Target duration
- 7 Years
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Sclerosi Multipla
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bari Aldo Moro
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636876
- Sponsor's protocol ID
- RISM - FISM 2015/S/1
- Acronym
- RISM
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 39329242Trojano 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.
PubMed 30426289Mosconi 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.
PubMed 37311951
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registro Italiano Sclerosi Multipla e Patologie Correlate
- ClinicalTrials.gov ID
- NCT07636876
- Acronym / sponsor ID
- RISM / RISM - FISM 2015/S/1
- Conditions
- Multiple Sclerosis, Neuromyelitis Optica, Demyelinating Diseases of the Central Nervous System, Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease, Clinically Isolated Syndrome, Radiologically Isolated Syndrome
- Keywords
- Epidemiology, Pharmacoepidemiology, Disease Registry, Patient Registry, Disease Modifying Treatment, Autoimmune Diseases, Multiple Sclerosis, Real-World Data
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 96,000 participants (estimated)
- Lead sponsor
- Fondazione Italiana Sclerosi MultiplaUniversity, hospital or other
- Collaborators
- University of Bari Aldo Moro
- Study start
- 17 Sep 2014 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 9 Jun 2026 (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.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis (MS) | – | – |
| Neuromyelitis Optica Spectrum Disorders (NMOSD) | – | – |
| Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD) | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
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
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.
Description of demographic characteristics
Time frame: 1 year
Female/male ratio.
Description of demographic characteristics
Time frame: 1 year
Distributions of age at onset in years.
Description of demographic characteristics
Time frame: 1 year
Interval between onset and diagnosis dates in years.
Expanded Disability Status Scale (EDSS)
Time frame: 1 year
Number of EDSS scores collected every 6 and 12 months by each center.
Disease-modifying treatment description
Time frame: 1 year
Distribution of patients with/without a DMT prescription.
Disease-modifying treatment description
Time frame: 1 year
Interval between diagnosis and first DMT start dates in years.
Disease-modifying treatment description
Time frame: 1 year
Frequencies of first and last DMT.
Magnetic Resonance Imaging (MRI)
Time frame: 1 year
Number of MRI exams collected every year by each center.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Results publication: PubMed 39329242Ponzio 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.
- Results publication: PubMed 30426289Trojano 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.
- Results publication: PubMed 37311951Mosconi 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.
- Public website of the Italian Multiple Sclerosis and Related Disorders RegisterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Multiple Sclerosis and Neuromyelitis Optica, run by Fondazione Italiana Sclerosi Multipla at 1 site in Italy.
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 1 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: enrolling by invitation, as of the sponsor's last update on 9 Jun 2026. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of cases included (time frame: 1 year). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07636876, which also lists 3 linked publications.
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 9 Jun 2026.