Silent Progression Activity Monitoring

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-03-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients

Patients with RRMS (2017 Mc Donald criteria) treated with highly active treatment in the first 5 years of symptoms onset, at least 1 year, with an EDSS below 4

NO INTERVENTION

Intervention Type OTHER

NO INTERVENTION

Interventions

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NO INTERVENTION

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* HAT start after April 12th 2007 (availability of Natalizumab)
* Naive or failure (or intolerability) to 1 or more first line DMT (injectables, teriflunomide, DMF).

Exclusion Criteria

* Progressive relapsing MS at baseline
* Clinical or basic MRI data unavailable after on-site visit.
* MS diagnostic \> 5 years at baseline
* Immunosuppressive drugs (Azathioprine, Cyclophosphamide, Mycophenolate, Methotrexate) prescribed before HAT initiation

Eligible Sex

ALL

Accepts Healthy Volunteers

No