Comparison of Rituximab Induction Therapy Followed by Glatiramer Acetate

What Was Tested

In this phase 2 trial, researchers set out to test Glatiramer Acetate for multiple sclerosis.

It had two arms (groups): (Placebo and) Glatiramer Acetate (active comparator) and Rituximab and Glatiramer Acetate (R-GA) (experimental).

The registry classes the interventions as drug and other.

More on the Plan

This is a double blind, active comparator; single-center study involving up to 90 subjects with qualifying CIS or RMS.

Subjects who are not screen-failures must be randomized within 60 days of signing the informed consent document.

Subjects who are not randomized within these 60 days must be re-screened for enrollment into the study.

Study visits include screening, baseline/randomization (day 1), day 15, day 28 and then visits every 3 months for up to 2.5 years.

Who Took Part

The registry lists 53 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: 18 through 55 years of age. Women of child-bearing potential must agree to practice an acceptable method of birth control. No evidence of progressive multifocal leukoencephalopathy (PML) or primary central nervous system (PCNS) lymphoma. Neurologically stable with no evidence of relapse or corticosteroid treatment within 30 days prior to randomization. Subject must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with local regulatory requirements.

The full record lists 6 inclusion and 17 exclusion criteria; among the exclusions: ≥ 15 gels on baseline mri; treatment with interferon β, natalizumab, or fingolimod within three months of randomization; treatment with mitoxantrone, cyclophosphamide, or any other chemotherapeutic agent for ms or malignancy within 12 months of randomization.

How the Study Was Run

Design: randomized, parallel-group and quadruple-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.

As a double-blind Glatiramer Acetate study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2012-02 with completion listed for 2015-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of Disease-free Patients (time frame: Baseline through 24 months).

It also tracked 9 secondary outcomes, for example Time to Treatment Failure, Number of Subjects That Fail Treatment, Number of Relapse-free Subjects, Number of Patients Treated for Relapse With Corticosteroid, Number of Subjects Who Experience Multiple Relapses and Number of Patients That Develop Sustained Accumulation of Disability.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Glatiramer Acetate in 53 people with multiple sclerosis.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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