Trials / Completed
CompletedNCT05650281
Silent Progression Activity Monitoring - SPAM Study
Silent Progression Monitoring in Extreme Phenotypes. SP-MS, Despite an Effective Early Highly Active Treatment as a Paradigm SPAM Study (Silent Progression Activity Monitoring)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,230 (actual)
- Sponsor
- Centre Hospitalier Universitaire de Nice · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
Real-World Data (RWD) exploring the natural history of MS suggested that relapses do not significantly influence the progression of irreversible disability. Disability progression independent of relapses activity (PIRA) has been confirmed as a frequent relapsing-remitting multiple sclerosis (RRMS) phenomenon based on Randomized Clinical Trials (RCT). Recently, RWD demonstrated that the absence of markers of inflammation (No Evidence of Disease Activity (NEDA) at 2 years did not predict long-term stability. Silent progression has been proposed to describe the insidious disability that accrues many patients who satisfy traditional criteria for relapsing-remitting MS. In this study, the investigators would like to evaluate the occurrence of the SPMS in a population of RRMS patient with an Highly Active Treatment (HAT).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | NO INTERVENTION | NO INTERVENTION |
Timeline
- Start date
- 2023-01-01
- Primary completion
- 2023-03-31
- Completion
- 2023-03-31
- First posted
- 2022-12-14
- Last updated
- 2023-07-21
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT05650281. Inclusion in this directory is not an endorsement.