Comparison of Clinical Effects of Rituximab and Glatiramer Acetate in Secondary Progressive Multiple Sclerosis Patients

What Was Tested

This registered phase 2, phase 3 trial tested Glatiramer Acetate for multiple sclerosis.

The purpose of this study is to compare expanded disability status scale, annualized relapse rate, Gad-enhanced brain lesions, and side effects after administration of rituximab and glatiramer acetate among patients with active secondary progressive multiple sclerosis during a one year follow up through a randomized clinical trial.

It had two arms (groups): Rituximab (experimental) and Glatiramer acetate (experimental).

The registry classes the interventions as drug.

More on the Plan

Multiple sclerosis (MS) is an autoimmune inflammatory demyelinative disease of central nervous system.

This form of the disease leads to high rates of morbidity and mortality among patients.

Who Took Part

84 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

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

Examples of who could join: Age between 18 and 55 years old. Diagnosis of active secondary progressive multiple sclerosis based on the latest McDonald criteria in 2010. Experiencing at least one relapse during the last year. Expanded disability status scale ≤5. Diagnosis of secondary progressive MS for at least one year.

The full record lists 7 inclusion and 24 exclusion criteria; among the exclusions: diagnosis of other subtypes of ms, including relapsing-remitting ms and primary progressive ms and inactive form of the disease; experiencing relapse during the 30 days before starting the study; receiving systemic corticosteroid therapy during the last 30 days.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Glatiramer Acetate and who got the comparison, which limits bias.

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

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 2017-12-01 with completion listed for 2019-02-01.

It ran at 1 site in Iran.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Disability measured by Expanded Disability Status Scale (time frame: one year).

It also tracked 3 secondary outcomes, for example Adverse Drug Reactions, number of Gadolinium-enhanced brain lesions and neuroimaging findings and Annualized relapse rate.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Glatiramer Acetate in 84 people with multiple sclerosis.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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