Silent Progression Activity Monitoring - SPAM Study

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: NO INTERVENTION

• Registration Number: NCT05650281
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-08
• Study First Submitted QC: 2022-12-05
• Study First Posted: 2022-12-14
• Study Start: 2023-01-01
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-20
• Last Update Posted: 2023-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2230

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	NO INTERVENTION	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

Primary Outcome Measures

Name	Time	Method
Determination of baseline clinical markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.	Baseline: beginning of highly active treatment	DMT administered since MS onset: number of DMT and type
Determination of baseline MRI markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.	Baseline: beginning of highly active treatment	At least 1 gadolinium enhancement T1 lesion on MRI

Secondary Outcome Measures

Name	Time	Method
To determine re-baseline MRI markers associated with SPMS diagnosis despite an early, practical, HAT.	Re-baseline definition: any patient with at least an EDSS and MRI examination performed 12 months after HAT onset. +/- 6 months (from 6 to 18 months).	At least 1 spinal cord T2 lesion on MRI
To determine re-baseline clinical and MRI markers associated with SPMS diagnosis despite an early, practical, HAT.	Re-baseline definition: any patient with at least an EDSS and MRI examination performed 12 months after HAT onset. +/- 6 months (from 6 to 18 months).	At least 1 gadolinium enhancement T1 lesion on MRI
Detremination of the impact of different definition of SPMS according to the clinician	Re-baseline definition: any patient with at least an EDSS and MRI examination performed 12 months after HAT onset. +/- 6 months (from 6 to 18 months).	The definition of SPMS according to the clinician : neurological episode = start of progression as assessed by the time to develop SPMS in years.
Dertermination of the impact of different definition of SPMS according to Lublin.	at 5 years	The definition of SPMS according to Lublin : progressive accumulation of disability after a primary relapsing course which must be confirmed at least 6 months after, as assessed by the time to develop SPMS in years.
To find a composite score usable at baseline when prescribing early HAT in clinical practice to predict early SPMS	at 5 years	All baseline variables will be evaluated in association with the prescriptio of an early HAT to predict early SPMS.
To determine re-baseline clinical markers associated with SPMS diagnosis despite an early, practical, HAT.	Re-baseline definition: any patient with at least an EDSS and MRI examination performed 12 months after HAT onset. +/- 6 months (from 6 to 18 months).	EDSS (which must be \<4) +/- 3 months
Analyze of the influence of NEDA (No Evidence of Disease activity)	at baseline and at 5 years	The disease activity will be evalued by the NEDA score
Analyze of the influence of MEDA (Mild Evidence of Disease Activity)	at baseline and at 5 years	The disease activity will be evalued by the MEDA score
Dertermination of the impact of different definition of SPMS according to Lorscheider.	at 5 years	The definition of SPMS according to Lorscheider: with a minimum EDSS of 4 , an increase by 1 point if the EDSS was between 4 and 5.5, or an increase by 0.5 points if the EDSS was above 5.5, confirmed after 3 months., as assessed by the time to develop SPMS in years.

Trial Locations

Locations (1)

CHU de Nice; 🇫🇷 Nice, France