Silent Progression Activity Monitoring - SPAM Study
SPAM
Silent Progression Monitoring in Extreme Phenotypes. SP-MS, Despite an Effective Early Highly Active Treatment as a Paradigm SPAM Study (Silent Progression Activity Monitoring)
1 other identifier
observational
2,230
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2022
CompletedFirst Posted
Study publicly available on registry
December 14, 2022
CompletedStudy Start
First participant enrolled
January 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2023
CompletedJuly 21, 2023
July 1, 2023
3 months
August 8, 2022
July 20, 2023
Conditions
Outcome Measures
Primary Outcomes (15)
Determination of baseline clinical markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.
Age in years
Baseline: beginning of highly active treatment
Determination of baseline clinical markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.
Disease duration (which should be \<5 years) in months
Baseline: beginning of highly active treatment
Determination of baseline clinical markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.
Expanded Disability Status Scale (EDSS) (which must be \<4)
Baseline: beginning of highly active treatment
Determination of baseline MRI markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.
new T2 lesion(s) on brain MRI and spinal cord MRI (if available)
Baseline: beginning of highly active treatment
Determination of baseline MRI markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.
gadolinium enhancement on brain MRI and spinal cord MRI (if available)
Baseline: beginning of highly active treatment
Determination of baseline clinical markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.
Interval time between the first and the second relapse in months
Baseline: beginning of highly active treatment
Determination of baseline clinical markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.
Reason for HAT: naive, or switch
Baseline: beginning of highly active treatment
Determination of baseline clinical markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.
Number of relapses since MS onset
Baseline: beginning of highly active treatment
Determination of baseline clinical markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.
DMT administered since MS onset: number of DMT and type
Baseline: beginning of highly active treatment
Determination of baseline MRI markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.
More than 9 T2 lesions on MRI
Baseline: beginning of highly active treatment
Determination of baseline MRI markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.
At least 1 periventicular T2 lesion on MRI
Baseline: beginning of highly active treatment
Determination of baseline MRI markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.
At least 3 periventicular T2 lesions on MRI
Baseline: beginning of highly active treatment
Determination of baseline MRI markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.
At least 1 infratentorial T2 lesion on MRI
Baseline: beginning of highly active treatment
Determination of baseline MRI markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.
At least 1 spinal cord T2 lesion on MRI
Baseline: beginning of highly active treatment
Determination of baseline MRI markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.
At least 1 gadolinium enhancement T1 lesion on MRI
Baseline: beginning of highly active treatment
Secondary Outcomes (21)
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).
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).
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).
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).
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).
- +16 more secondary outcomes
Study Arms (1)
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
Interventions
Eligibility Criteria
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
You may qualify if:
- HAT start after April 12th 2007 (availability of Natalizumab)
- Naive or failure (or intolerability) to 1 or more first line DMT (injectables, teriflunomide, DMF).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Nice
Nice, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2022
First Posted
December 14, 2022
Study Start
January 1, 2023
Primary Completion
March 31, 2023
Study Completion
March 31, 2023
Last Updated
July 21, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share