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)

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

— SWITCH - ITA  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05658601
• Other study ID #: IM047-1038
• Status: Recruiting
• Start date: July 14, 2023
• Est. completion date: January 31, 2027

Study information

• Verified date: January 2024
• Source: Bristol-Myers Squibb
• Contact: BMS Study Connect Contact Center http://www.bmsstudyconnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: January 31, 2027
• Est. primary completion date: January 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Locations

Country	Name	City	State
Italy	Neuromed Istituto Neurologico Mediterraneo	Isernia

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At baseline
Primary	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	At baseline
Secondary	Expanded Disability Status Score (EDSS)	Mean EDSS score in patients enrolled in the study	At baseline, week 12, and week 24
Secondary	MRI	Number of new or enlarging T2 lesions and T1 Gadolinium Enhancing Lesions (GdE) lesions.	At baseline, week 12, and week 24
Secondary	TSQM	Treatment Satisfaction Questionnaire for Medication	At baseline and week 24
Secondary	Lymphocyte sub populations	The pattern of the sub populations of lymphocytes: CD3, CD4, CD8, CD19, CD56.	At baseline, week 12, and week 24
Secondary	Incidence of Adverse Events (AEs)	Number of AEs in the study population during the study; AEs will be coded according to MEdDRA.	Continuous (Up to 42 months)
Secondary	Incidence of Serious Adverse Events (SAEs)	Number of SAEs in the study population during the study; SAEs will be coded according to MEdDRA.	Continuous (Up to 42 months)

External Links

•   BMS Clinical Trial Information