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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | No 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. |
| Secondary | Absence of clinical relapses | From 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. |
| Secondary | Annualised relapse rate | From treatment baseline through study completion, up to 24 years | Number of clinical relapses per participant-year of follow-up. |
| Secondary | Absence of MRI activity | From 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. |
| Secondary | Absence 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. |
| Secondary | Absence 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. |
| Secondary | Probability 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. |
| Secondary | Time to first clinical relapse | From treatment baseline through study completion, up to 24 years | Time from treatment baseline to the first clinical relapse. |
| Secondary | Time to first MRI activity | From treatment baseline through study completion, up to 24 years | Time from treatment baseline to the first MRI showing new or enlarging T2 lesions and/or gadolinium-enhancing T1 lesions compared with the reference scan. |
| Secondary | Time to 6-month confirmed disability progression | From treatment baseline through study completion, up to 24 years | Time from treatment baseline to the first occurrence of 6-month confirmed disability progression, assessed using EDSS criteria. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes0
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.
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.
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