Skip to main content
OpenTrials
Completed

NCT Number: NCT05650281

Silent Progression Activity Monitoring - SPAM Study

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nice

Nice, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion 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

  • HAT start after April 12th 2007 (availability of Natalizumab)
  • Naive or failure (or intolerability) to 1 or more first line DMT (injectables, teriflunomide, DMF).
  • EDSS < or equal 4 when starting HAT 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

Treatment and study plan

No intervention

Other

NO INTERVENTION

Primary outcomes

  1. Determination of baseline clinical markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.

    Time frame: Baseline: beginning of highly active treatment

    Age in years

  2. Determination of baseline clinical markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.

    Time frame: Baseline: beginning of highly active treatment

    Disease duration (which should be <5 years) in months

  3. Determination of baseline clinical markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.

    Time frame: Baseline: beginning of highly active treatment

    Expanded Disability Status Scale (EDSS) (which must be <4)

  4. Determination of baseline MRI markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.

    Time frame: Baseline: beginning of highly active treatment

    new T2 lesion(s) on brain MRI and spinal cord MRI (if available)

  5. Determination of baseline MRI markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.

    Time frame: Baseline: beginning of highly active treatment

    gadolinium enhancement on brain MRI and spinal cord MRI (if available)

  6. Determination of baseline clinical markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.

    Time frame: Baseline: beginning of highly active treatment

    Interval time between the first and the second relapse in months

  7. Determination of baseline clinical markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.

    Time frame: Baseline: beginning of highly active treatment

    Reason for HAT: naive, or switch

  8. Determination of baseline clinical markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.

    Time frame: Baseline: beginning of highly active treatment

    Number of relapses since MS onset

  9. Determination of baseline clinical markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.

    Time frame: Baseline: beginning of highly active treatment

    DMT administered since MS onset: number of DMT and type

  10. Determination of baseline MRI markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.

    Time frame: Baseline: beginning of highly active treatment

    More than 9 T2 lesions on MRI

  11. Determination of baseline MRI markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.

    Time frame: Baseline: beginning of highly active treatment

    At least 1 periventicular T2 lesion on MRI

  12. Determination of baseline MRI markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.

    Time frame: Baseline: beginning of highly active treatment

    At least 3 periventicular T2 lesions on MRI

  13. Determination of baseline MRI markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.

    Time frame: Baseline: beginning of highly active treatment

    At least 1 infratentorial T2 lesion on MRI

  14. Determination of baseline MRI markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.

    Time frame: Baseline: beginning of highly active treatment

    At least 1 spinal cord T2 lesion on MRI

  15. Determination of baseline MRI markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.

    Time frame: Baseline: beginning of highly active treatment

    At least 1 gadolinium enhancement T1 lesion on MRI

Secondary outcomes

  1. To determine re-baseline clinical markers associated with SPMS diagnosis despite an early, practical, HAT.

    Time frame: 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).

    Age in years

  2. To determine re-baseline clinical markers associated with SPMS diagnosis despite an early, practical, HAT.

    Time frame: 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).

    Disease duration (which should be <5 years) in months

  3. To determine re-baseline clinical markers associated with SPMS diagnosis despite an early, practical, HAT.

    Time frame: 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

  4. To determine re-baseline MRI markers associated with SPMS diagnosis despite an early, practical, HAT.

    Time frame: 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).

    new T2 lesion(s) on brain MRI and spinal cord MRI (if available)

  5. To determine re-baseline MRI markers associated with SPMS diagnosis despite an early, practical, HAT.

    Time frame: 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).

    gadolinium enhancement on brain MRI and spinal cord MRI (if available)

  6. To determine re-baseline MRI markers associated with SPMS diagnosis despite an early, practical, HAT.

    Time frame: 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).

    Interval time between the first and the second relapse in months

  7. To determine re-baseline MRI markers associated with SPMS diagnosis despite an early, practical, HAT.

    Time frame: 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).

    Number of relapses since MS onset

  8. To determine re-baseline MRI markers associated with SPMS diagnosis despite an early, practical, HAT.

    Time frame: 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).

    Number of relapse before baseline

  9. To determine re-baseline MRI markers associated with SPMS diagnosis despite an early, practical, HAT.

    Time frame: 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).

    Disease Modifying Therapies (DMT) administered since MS onset

  10. To determine re-baseline MRI markers associated with SPMS diagnosis despite an early, practical, HAT.

    Time frame: 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).

    More than 9 T2 lesions on MRI

  11. To determine re-baseline MRI markers associated with SPMS diagnosis despite an early, practical, HAT.

    Time frame: 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 periventicular T2 lesion on MRI

  12. To determine re-baseline MRI markers associated with SPMS diagnosis despite an early, practical, HAT.

    Time frame: 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 3 periventicular T2 lesion on MRI

  13. To determine re-baseline MRI markers associated with SPMS diagnosis despite an early, practical, HAT.

    Time frame: 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 infratentorial T2 lesion on MRI

  14. To determine re-baseline MRI markers associated with SPMS diagnosis despite an early, practical, HAT.

    Time frame: 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

  15. To determine re-baseline clinical and MRI markers associated with SPMS diagnosis despite an early, practical, HAT.

    Time frame: 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

  16. Detremination of the impact of different definition of SPMS according to the clinician

    Time frame: 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.

  17. Dertermination of the impact of different definition of SPMS according to Lublin.

    Time frame: 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.

  18. Dertermination of the impact of different definition of SPMS according to Lorscheider.

    Time frame: 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.

  19. Analyze of the influence of NEDA (No Evidence of Disease activity)

    Time frame: at baseline and at 5 years

    The disease activity will be evalued by the NEDA score

  20. Analyze of the influence of MEDA (Mild Evidence of Disease Activity)

    Time frame: at baseline and at 5 years

    The disease activity will be evalued by the MEDA score

  21. To find a composite score usable at baseline when prescribing early HAT in clinical practice to predict early SPMS

    Time frame: at 5 years

    All baseline variables will be evaluated in association with the prescriptio of an early HAT to predict early SPMS.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Silent Progression Monitoring in Extreme Phenotypes. SP-MS, Despite an Effective Early Highly Active Treatment as a Paradigm SPAM Study (Silent Progression Activity Monitoring)

Acronym: SPAM

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 14, 2022
Registry last updated
Jul 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.