Clinical Trials Directory

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

TypeNameDescription
OTHERNO INTERVENTIONNO 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.

Silent Progression Activity Monitoring - SPAM Study (NCT05650281) · Clinical Trials Directory