Multiple SclerosisSPAMNCT05650281
Silent Progression Activity Monitoring - SPAM Study
An observational study of Multiple Sclerosis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 2,230 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2023to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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)
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).
- Conditions
- Multiple Sclerosis
- Being tested
- NO INTERVENTION
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NO INTERVENTIONOther
NO INTERVENTION
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: NO INTERVENTION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of baseline clinical markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.
Age in years
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline: beginning of highly active treatment
Secondary outcomes (21)
To determine re-baseline clinical markers associated with SPMS diagnosis despite an early, practical, HAT.
Age in years
Measured: 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.
Disease duration (which should be <5 years) in months
Measured: 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.
EDSS (which must be <4) +/- 3 months
Measured: 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.
new T2 lesion(s) on brain MRI and spinal cord MRI (if available)
Measured: 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.
gadolinium enhancement on brain MRI and spinal cord MRI (if available)
Measured: 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.
Interval time between the first and the second relapse in months
Measured: 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.
Number of relapses since MS onset
Measured: 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.
Number of relapse before baseline
Measured: 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.
Disease Modifying Therapies (DMT) administered since MS onset
Measured: 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.
More than 9 T2 lesions on MRI
Measured: 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.
At least 1 periventicular T2 lesion on MRI
Measured: 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.
At least 3 periventicular T2 lesion on MRI
Measured: 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.
At least 1 infratentorial T2 lesion on MRI
Measured: 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.
At least 1 spinal cord T2 lesion on MRI
Measured: 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.
At least 1 gadolinium enhancement T1 lesion on MRI
Measured: 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
The definition of SPMS according to the clinician : neurological episode = start of progression as assessed by the time to develop SPMS in years.
Measured: 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.
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.
Measured: at 5 years
Dertermination of the impact of different definition of SPMS according to Lorscheider.
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.
Measured: at 5 years
Analyze of the influence of NEDA (No Evidence of Disease activity)
The disease activity will be evalued by the NEDA score
Measured: at baseline and at 5 years
Analyze of the influence of MEDA (Mild Evidence of Disease Activity)
The disease activity will be evalued by the MEDA score
Measured: 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
All baseline variables will be evaluated in association with the prescriptio of an early HAT to predict early SPMS.
Measured: at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start1 Jan 2023
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05650281
- Sponsor's protocol ID
- 22Neuro03
- Acronym
- SPAM
- Status last verified
- Jul 2023
- First submitted
- 8 Aug 2022
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT05650281
- Acronym / sponsor ID
- SPAM / 22Neuro03
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,230 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 14 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: NO INTERVENTIONPatients 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NO INTERVENTIONNO INTERVENTION | Other | Patients |
Primary outcome
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
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
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)
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)
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)
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
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
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
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
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
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
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
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
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
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
21 secondary outcomes
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
Dertermination of the impact of different definition of SPMS according to Lublin.
Time frame: at 5 years
Dertermination of the impact of different definition of SPMS according to Lorscheider.
Time frame: at 5 years
Analyze of the influence of NEDA (No Evidence of Disease activity)
Time frame: 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
To find a composite score usable at baseline when prescribing early HAT in clinical practice to predict early SPMS
Time frame: at 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of baseline clinical markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment. (time frame: Baseline: beginning of highly active treatment). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.