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Trial · NCT07189325

A Prospective Randomized Non-inferiority Trial Comparing Anti-CD20 Maintenance Versus De-Escalation Strategy In Relapsing-Remitting Multiple Sclerosis

NCT07189325, Phase 3, Recruiting, University Hospital, Montpellier

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Prospective Randomized Non-inferiority Trial Comparing Anti-CD20 Maintenance Versus De-Escalation Strategy In Relapsing-Remitting Multiple Sclerosis. Trials, record NCT07189325. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07189325

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Trial

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

Title
A Prospective Randomized Non-inferiority Trial Comparing Anti-CD20 Maintenance Versus De-Escalation Strategy In Relapsing-Remitting Multiple Sclerosis
NCT number
NCT07189325
Status
Recruiting
Phases
Phase 3
Enrollment
250 participants, estimated
Lead sponsor
University Hospital, Montpellier
Conditions
Relapsing-Remitting Multiple Sclerosis (RRMS), Anti-CD20 Therapy
Interventions
Platform therapies (Dimethyl Fumarate, Teriflunomide, Glatiramer Acetate, Beta-interferons), Anti-CD20 therapies (Ocrelizumab, Rituximab, Ofatumumab)
First posted
2025-09-23
Last updated
2026-06-23

Source ClinicalTrials.gov

Registered outcomes16

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

ListOutcomeTime frameDescription
PrimaryRelapseFrom Day 0 to Month 36
Presence of at least one clinical relapse defined as new or worsening symptoms related to MS resulting in objective signs on neurological examination in the absence of any potential trigger not related to MS.
PrimaryNew/enlarged MRI lesionsFrom Day 0 to Month 36New/enlarged T2/FLAIR lesion on MRI scans to assess MRI disease activity .
SecondaryRelapseFrom Day 0 to Month 36
Presence of at least one clinical relapse defined as new or worsening symptoms related to MS resulting in objective signs on neurological examination in the absence of any potential trigger not related to MS
SecondaryExpanded Disability Status Scale (EDSS)From Day 0 to Month 36
EDSS to compare disability between both groups. This score is expressed from 0 (no disability) to 10 (multiple sclerosis-related death) and incorporates evaluation of the following neurological systems (pyramidal, sensory, cerebellar, sphincter, cognitive, and cranial pairs)
SecondaryBrain MRI (T2/FLAIR Lesions)From Day 0 to Month 36MRI scans to compare new/enlarged T2/FLAIR lesions between both groups.
SecondaryNumber of adverse events and severe adverse eventsFrom Day 0 to Month 36To compare adverse events and severe adverse events between both groups.
SecondaryNumber of infections and serious infectionsFrom Day 0 to Month 36To compare infections and serious infections between both groups.
SecondaryB-cell count (CD19/CD20 B cells)From Day 0 to Month 36B-cell count (CD19/CD20 B cells) to compare C• B-cells repopulation (CD19/CD20+ B-cells) between both groups.
SecondarySerum immunoglobulin (IgG, IgA, IgM) levelsFrom Day 0 to Month 36Serum immunoglobulin (IgG, IgA, IgM) levels to compare • Immunoglobulin (IgG, A, M) levels changes between both groups.
OtherMultiple Sclerosis Functional Composite (MSFC)From Day 0 to Month 36MSFC including the 9-Hole Peg Test (9HPT), Timed 25 Foot Walk (T25FW), and Paced Auditory Serial Addition Test (PASAT) to compare functional disability between both groups.

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.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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.

Tests1

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

TestNamed as
Paced Visual Serial Addition TestOther outcome

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/NCT07189325

GET https://conductscience.org/api/trials/v1/NCT07189325/registered