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Trial · NCT07899502

REAL-MS: Observational Database Study of AHSCT and MS Therapies

NCT07899502, Recruiting, Imperial College London

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. REAL-MS: Observational Database Study of AHSCT and MS Therapies. Trials, record NCT07899502. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07899502

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
REAL-MS: Observational Database Study of AHSCT and MS Therapies
NCT number
NCT07899502
Status
Recruiting
Enrollment
2,000 participants, estimated
Lead sponsor
Imperial College London
Conditions
Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting, Multiple Sclerosis (MS) Primary Progressive
Interventions
Autologous haematopoietic stem cell transplantation (AHSCT), High-efficacy disease-modifying therapy (HE-DMT)
First posted
2026-10-27
Last updated
2026-10-27

Source ClinicalTrials.gov

Registered outcomes18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNo Evidence of Disease Activity (NEDA-3)From treatment baseline through study completion, up to 24 years
Composite time-to-event outcome. NEDA-3 failure is the first occurrence of a clinical relapse, MRI activity, or 6-month confirmed disability progression. Clinical relapse is new or worsening MS-related neurological symptoms lasting at least 24 hours, without fever, infection, or another explanation. MRI activity is new or enlarging T2 lesions and/or gadolinium-enhancing T1 lesions. Confirmed disability progression is assessed using the Expanded Disability Status Scale and confirmed after 6 months.
SecondaryAbsence of clinical relapsesFrom treatment baseline through study completion, up to 24 years
Proportion of participants with no clinical relapse during follow-up. A clinical relapse is new or worsening neurological symptoms attributable to MS, lasting at least 24 hours, occurring without fever, infection, or another alternative explanation, and separated from a previous relapse by at least 30 days.
SecondaryAnnualised relapse rateFrom treatment baseline through study completion, up to 24 yearsNumber of clinical relapses per participant-year of follow-up.
SecondaryAbsence of MRI activityFrom treatment baseline through study completion, up to 24 years
Proportion of participants with no MRI activity during follow-up. MRI activity is defined as new or enlarging T2 lesions and/or gadolinium-enhancing T1 lesions on follow-up MRI compared with the reference scan.
SecondaryAbsence of 6-month confirmed disability progression (CDP)From treatment baseline through study completion, up to 24 years
Proportion of participants without 6-month CDP, assessed using the Expanded Disability Status Scale (EDSS). Confirmed disability progression is an increase in EDSS of 1.0 point when baseline EDSS is below 6.0, or 0.5 point when baseline EDSS is 6.0 or higher, confirmed 6 months after the reported change.
SecondaryAbsence of progression independent of relapse activity (PIRA)From treatment baseline through study completion, up to 24 years
Proportion of participants without PIRA. PIRA is defined as confirmed disability progression occurring without a relapse during the 90 days before and 30 days after the event, including the 90 days before and 30 days after confirmation.
SecondaryProbability of 6-month confirmed disability improvement (CDI)From treatment baseline through study completion, up to 24 years
Proportion of participants with 6-month CDI, defined as a decrease in EDSS of 1.0 point when baseline EDSS is below 6.0, or 0.5 point when baseline EDSS is 6.0 or higher, confirmed 6 months after the reported change.
SecondaryTime to first clinical relapseFrom treatment baseline through study completion, up to 24 yearsTime from treatment baseline to the first clinical relapse.
SecondaryTime to first MRI activityFrom treatment baseline through study completion, up to 24 yearsTime from treatment baseline to the first MRI showing new or enlarging T2 lesions and/or gadolinium-enhancing T1 lesions compared with the reference scan.
SecondaryTime to 6-month confirmed disability progressionFrom treatment baseline through study completion, up to 24 yearsTime from treatment baseline to the first occurrence of 6-month confirmed disability progression, assessed using EDSS criteria.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers9

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
25672923RESULTPubMed
28621766RESULTPubMed
30644983RESULTPubMed
32418281BACKGROUNDPubMed
33106366BACKGROUNDPubMed
37437240BACKGROUNDPubMed
39814869RESULTPubMed
40251896BACKGROUNDPubMed
40755195BACKGROUNDPubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07899502

GET https://conductscience.org/api/trials/v1/NCT07899502/registered