Silent Progression Activity Monitoring - SPAM Study (SPAM)

July 20, 2023 updated by: Centre Hospitalier Universitaire de Nice

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2230

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Nice, France
        • CHU de NICE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other: NO INTERVENTION
NO INTERVENTION

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline: beginning of highly active treatment
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
Baseline: beginning of highly active treatment
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)
Baseline: beginning of highly active treatment
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)
Baseline: beginning of highly active treatment
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)
Baseline: beginning of highly active treatment
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
Baseline: beginning of highly active treatment
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
Baseline: beginning of highly active treatment
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
Baseline: beginning of highly active treatment
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
Baseline: beginning of highly active treatment
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
Baseline: beginning of highly active treatment
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
Baseline: beginning of highly active treatment
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
Baseline: beginning of highly active treatment
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
Baseline: beginning of highly active treatment
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
Baseline: beginning of highly active treatment
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
Baseline: beginning of highly active treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
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
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.
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
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.
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)
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.
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)
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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 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
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).
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.
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).
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.
at 5 years
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.
at 5 years
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
at baseline and at 5 years
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
at baseline and at 5 years
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.
at 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22Neuro03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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