Multiple Sclerosis, Relapsing-RemittingSWITCH - ITANCT05658601
A Study to Describe the Switching From a First- or Second-line Disease Modifying Therapy (DMT) to Ozanimod in Participants With Relapsing Remitting Multiple Sclerosis (RRMS)
An observational study of Multiple Sclerosis, Relapsing-Remitting, run by Bristol-Myers Squibb at 1 site in Italy.
Trial summary
The purpose of this study is to describe the reasons, therapy, and/or disease for changing first or second line Disease Modifying Therapy (DMT) to ozanimod in participants with Relapsing Remitting Multiple Sclerosis (RRMS). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- How many people
- 104 participants
- Where
- 1 siteItaly
- Study dates
- 14 Jul 2023to 3 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study population is composed of 180 participants 18-55 years with Relapsing Remitting Multiple Sclerosis (RRMS) diagnosed according to 2017 revised McDonald criteria, switching from a first or second line Disease Modifying Therapy (DMT) to ozanimod, and in treatment with ozanimod between 4 and 12 weeks before the enrollment.
Who may be able to join
- Patients with RRMS according to 2017 revised McDonald criteria
- Patients who switched a previous first or second line DMT to ozanimod between 4 and 12 weeks before the enrollment
- Patient with a MRI performed within three months before the enrollment
- Patient eligible to ozanimod according to SmPC
Who cannot join
- Patients with clinical forms of MS other than RRMS
- Patients unable to participate for various reasons
- Patients participating in another clinical study with an investigational product if the study considers the switching behavior as an endpoint or objective
- Contraindications to ozanimod according to SmPC
- Other protocol-defined Inclusion/Exclusion Criteria apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SWITCH - ITA A Multicentre, Single Country, Prospective Non Interventional Observational Study to Describe the Switching From a First- or Second-line Disease Modifying Therapy (DMT) to Ozanimod, in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Treated According to Clinical Practice.
The purpose of this study is to describe the reasons, therapy, and/or disease for changing first or second line Disease Modifying Therapy (DMT) to ozanimod in participants with Relapsing Remitting Multiple Sclerosis (RRMS).
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Multiple Sclerosis, Ozanimod
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
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 |
|---|---|---|
| Cohort 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reason for switching treatment
Reason for switching the previous treatment: Lack of efficacy, Poor safety/tolerability, Difficulty in administration, Poor compliance, Patient's request, or other reasons
Measured: At baseline
Mode of switching treatment
Wash-out from previous treatment (first/second line DMT) (days), overlapping (days), dosage (first/second line DMT and ozanimod), concomitant treatments
Measured: At baseline
Secondary outcomes (6)
Expanded Disability Status Score (EDSS)
Mean EDSS score in patients enrolled in the study
Measured: At baseline, week 12, and week 24
MRI
Number of new or enlarging T2 lesions and T1 Gadolinium Enhancing Lesions (GdE) lesions.
Measured: At baseline, week 12, and week 24
TSQM
Treatment Satisfaction Questionnaire for Medication
Measured: At baseline and week 24
Lymphocyte sub populations
The pattern of the sub populations of lymphocytes: CD3, CD4, CD8, CD19, CD56.
Measured: At baseline, week 12, and week 24
Incidence of Adverse Events (AEs)
Number of AEs in the study population during the study; AEs will be coded according to MEdDRA.
Measured: Continuous (Up to 42 months)
Incidence of Serious Adverse Events (SAEs)
Number of SAEs in the study population during the study; SAEs will be coded according to MEdDRA.
Measured: Continuous (Up to 42 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start14 Jul 2023
- Primary completion3 Jul 2025
- Study completion3 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658601
- Sponsor's protocol ID
- IM047-1038
- Acronym
- SWITCH - ITA
- Status last verified
- Sep 2025
- First submitted
- 12 Dec 2022
- Last updated
- 1 Oct 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SWITCH - ITA A Multicentre, Single Country, Prospective Non Interventional Observational Study to Describe the Switching From a First- or Second-line Disease Modifying Therapy (DMT) to Ozanimod, in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Treated According to Clinical Practice.
- ClinicalTrials.gov ID
- NCT05658601
- Acronym / sponsor ID
- SWITCH - ITA / IM047-1038
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Multiple Sclerosis, Ozanimod
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2023 (actual)
- Primary completion
- 3 Jul 2025 (actual)
- Study completion
- 3 Jul 2025 (actual)
- First posted
- 21 Dec 2022 (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 purpose of this study is to describe the reasons, therapy, and/or disease for changing first or second line Disease Modifying Therapy (DMT) to ozanimod in participants with Relapsing Remitting Multiple Sclerosis (RRMS).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population is composed of 180 participants 18-55 years with Relapsing Remitting Multiple Sclerosis (RRMS) diagnosed according to 2017 revised McDonald criteria, switching from a first or second line Disease Modifying Therapy (DMT) to ozanimod, and in treatment with ozanimod between 4 and 12 weeks before the enrollment.
Key inclusion criteria (4 listed)
- Patients with RRMS according to 2017 revised McDonald criteria
- Patients who switched a previous first or second line DMT to ozanimod between 4 and 12 weeks before the enrollment
- Patient with a MRI performed within three months before the enrollment
- Patient eligible to ozanimod according to SmPC
Key exclusion criteria (5 listed)
- Patients with clinical forms of MS other than RRMS
- Patients unable to participate for various reasons
- Patients participating in another clinical study with an investigational product if the study considers the switching behavior as an endpoint or objective
- Contraindications to ozanimod according to SmPC
- Other protocol-defined Inclusion/Exclusion Criteria apply.
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
Reason for switching treatment
Time frame: At baseline
Reason for switching the previous treatment: Lack of efficacy, Poor safety/tolerability, Difficulty in administration, Poor compliance, Patient's request, or other reasons
Mode of switching treatment
Time frame: At baseline
Wash-out from previous treatment (first/second line DMT) (days), overlapping (days), dosage (first/second line DMT and ozanimod), concomitant treatments
6 secondary outcomes
Expanded Disability Status Score (EDSS)
Time frame: At baseline, week 12, and week 24
MRI
Time frame: At baseline, week 12, and week 24
TSQM
Time frame: At baseline and week 24
Lymphocyte sub populations
Time frame: At baseline, week 12, and week 24
Incidence of Adverse Events (AEs)
Time frame: Continuous (Up to 42 months)
Incidence of Serious Adverse Events (SAEs)
Time frame: Continuous (Up to 42 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
Related trials for Multiple Sclerosis, Relapsing-Remitting
Active, not recruiting
Tai Chi Training for Persons With Multiple Sclerosis.
Multiple Sclerosis (MS) - Relapsing-remitting
RecruitingObservational study
REAL-MS: Observational Database Study of AHSCT and MS Therapies
Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting
RecruitingPhase 2
The HIt HArd and hiT Early in Multiple Sclerosis Trial
Relapsing-remitting Multiple Sclerosis
RecruitingPhase 3
Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)
Relapsing Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis
Not yet recruitingPhase 2
A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous Ocrelizumab Administration in Children and Adolescents With Relapsing-remitting Multiple Sclerosis (RRMS)
Relapsing-remitting Multiple Sclerosis
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. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
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, Relapsing-Remitting, run by Bristol-Myers Squibb 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 5 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: finished, as of the sponsor's last update on 1 Oct 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reason for switching treatment (time frame: At baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2025; AzTrials last refreshed its copy on 29 Oct 2026.