Relapsing-remitting Multiple Sclerosis (RRMS) Clinical Trial
— AppreZiateOfficial title:
Observational, Multicenter Study to Describe the Persistence in Relapsing Remitting Multiple Sclerosis Naive Patients With Low-moderate Activity Treated With Ozanimod (Zeposia®) in Clinical Practice in Spain
| NCT number | NCT05811416 |
| Other study ID # | IM047-066 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 14, 2023 |
| Est. completion date | March 31, 2026 |
The purpose of the study is to collect clinical data on the persistence with ozanimod treatment, as well as to describe its effects on participant-relevant outcome parameters in treatment-naïve participants with RRMS.
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | March 31, 2026 |
| Est. primary completion date | March 31, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Relapsing-remitting multiple sclerosis (RRMS) diagnosis by 2017 revised McDonald criteria at the treatment start - Participant who started treatment with ozanimod for the first time 3 months (+/- 2 weeks) before inclusion, according to European Union (EU) Summary of Product Characteristics (SmPC) and/or Spanish therapeutic positioning report (TPR) recommendation and following routine clinical practice of the participating hospital - Low-to-moderate activity, defined as less than 2 relapses in the previous year before starting the treatment with ozanimod Exclusion Criteria: - Prior exposure to ozanimod or any other disease modifier treatment (DMT) for RRMS before starting treatment with ozanimod subject of this study - Participant who has started ozanimod within a clinical trial Note: Other protocol-defined inclusion/exclusion criteria apply |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Local Institution - 0001 | Barcelona |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time from ozanimod treatment initiation to ozanimod treatment permanent discontinuation | Up to 24 months | ||
| Primary | Percentage of participants on treatment with ozanimod at 24 months | At month 24 | ||
| Secondary | Percentage of participants with ozanimod treatment at 3 and 12 months | At month 3 and month 12 | ||
| Secondary | Percentage of participants with ozanimod treatment discontinuation | Up to 24 months | ||
| Secondary | Percentage of participants switching to treatment alternative | Up to 24 months | ||
| Secondary | Annualized relapse rate at month 12 month and month 24 | At month 12 and month 24 | ||
| Secondary | Proportion of participants with an increase in Symbol Digit Modalities Test (SDMT) score of =4 points | At month 3, 12 and 24 | ||
| Secondary | Proportion of participants with a decrease SDMT score of =4 points | At month 3, 12 and 24 | ||
| Secondary | Proportion of participants with a stable SDMT score | At month 3, 12 and 24 | ||
| Secondary | Change from baseline in SDMT score at month 3, 12 and 24 | Baseline, Month 3, 12 and 24 | ||
| Secondary | Change from baseline in Neurofilament light (NfL) levels at month 6, 12 and 24 | Baseline, Month 6, 12 and 24 | ||
| Secondary | Proportion of participants with change of =1.0 point from baseline in expanded disability status scale (EDSS) score at Month 3, 12 and 24 | Baseline, Month 3, 12 and 24 | ||
| Secondary | Change from baseline in EDSS score at Month 3, 12 and 24 | Baseline, Month 3, 12 and 24 | ||
| Secondary | Change from baseline in number of new or enlarging hypointense T1 lesions at month 12 and 24 | Baseline, Month 12 and 24 | ||
| Secondary | Change from baseline in number of new or enlarging hypointense T2 lesions at month 12 and 24 | Baseline, Month 12 and 24 | ||
| Secondary | Change from baseline in number of new or enlarging gadolinium enhancing brain lesions at month 12 and 24 | Baseline, Month 12 and 24 | ||
| Secondary | Number of Participants with at least one Adverse Event (AE) | Up to 24 months | ||
| Secondary | Number of Participants with AE that imply discontinuation of ozanimod | Up to 24 months | ||
| Secondary | Description of sociodemographic characteristics of participants | Baseline, up to 24 months | ||
| Secondary | Description of clinical characteristics of participants | Baseline, up to 24 months |
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