Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS

What Was Tested

This registered phase 4 trial tested Glatiramer Acetate for multiple sclerosis.

It had three arms (groups): one (experimental), ESC: Escalation (experimental) and OBS: Observational (no intervention).

The registry classes the interventions as drug.

More on the Plan

EHT approach to DMT is defined as use of one of five monoclonal antibodies (alemtuzumab, natalizumab, rituximab, ocrelizumab, ofatumumab, ublituximab) as first-line therapy.

Once randomized, the Neurologist and Participant decide which DMT within the arm is most appropriate.

After the initial DMT is initiated, if a DMT change is needed, the second-line therapy may be chosen from either arm, regardless of randomization.

The randomization only applies to the initial DMT choice.

Who Took Part

800 planned participants were the target.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Men and women aged 18 to 60 years. Established diagnosis of MS, as defined by the 2017 revision of McDonald Diagnostic Criteria (99). Participants must be ambulatory with disease onset ≤ 5 years and treatment-naïve (i.e., no MS DMT at any time in the past). Participants must be eligible to receive at least one form of DMT within each treatment arm. EDSS at Baseline visit ≤ 6.5.

The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: participants with contraindications to all forms of dmt in either of the treatment arms; participants unable to provide informed consent.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The multiple sclerosis participants were allocated by chance, so the Glatiramer Acetate group and the comparison group should start out alike.

Groups ran in parallel: each of the multiple sclerosis participants stayed in one arm throughout.

Everyone knew when Glatiramer Acetate was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2019-01-03 with completion listed for 2027-07-30.

It ran at 30 sites in United States (15) and United Kingdom (15).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Brain volume loss, baseline to month 36 (time frame: Baseline to 36 months). EDSS+, month 48 to month 108 (time frame: 48 months to 108 months).

It also tracked 7 secondary outcomes, for example Brain volume loss, month 6 to month 36, Proportion of participants with progression, Change in MSIS-29, baseline to 36 months, Change in Neuro-QOL, baseline to 36 months, Time to reach SPMS, month 48 to month 108 and Safety difference between EHT and ESC, month 48 to month 108.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Glatiramer Acetate in 800 people with multiple sclerosis.

With 800 participants it is a large trial for this field.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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