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

What Was Tested

This registered phase 3 trial tested Glatiramer Acetate for multiple sclerosis.

It commonly starts during the third and fourth decades.

It had two arms (groups): Experimental Group (experimental) and Control Group (active comparator).

Patients randomized in the experimental group will be treated with platform therapies (Dimethyl Fumarate, Diroximel fumarate, Teriflunomide, Glatiramer Acetate, Beta-interferons) according to treatments' authorization from the day of randomization to M36.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 250 planned participants were the target.

It was open to people of any sex aged from 40 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients ≥40 years at inclusion. No evidence of disease activity for the last 3 years on anti-CD20 (No relapse AND no new/enlarged MRI lesion). Brain MRI performed according to OFSEP protocol within a maximum of 6 months before randomization. Secondary or primary progressive MS at inclusion. Previous experience of treatment failure in patients treated with natalizumab, fingolimod, rituximab, ocrelizumab, mitoxantrone, alemtuzumab or cladribine.

The full record lists 24 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

Because people in this Glatiramer Acetate study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Glatiramer Acetate group and the comparison group ran side by side rather than switching.

In this single-blind Glatiramer Acetate study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2026-06-15 with completion listed for 2031-06.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Relapse (time frame: From Day 0 to Month 36). New/enlarged MRI lesions (time frame: From Day 0 to Month 36).

It also tracked 7 secondary outcomes, for example Relapse, Expanded Disability Status Scale (EDSS), Brain MRI (T2/FLAIR Lesions), Number of adverse events and severe adverse events, Number of infections and serious infections and B-cell count (CD19/CD20 B cells).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Glatiramer Acetate in 250 people with multiple sclerosis.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glatiramer Acetate compound page, Multiple sclerosis research.