Combination Therapy in Patients With Relapsing-Remitting Multiple Sclerosis (MS)CombiRx

What Was Tested

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

This is for a randomized clinical trial (RCT) to determine if the combined use of interferon beta-1a (IFN) and glatiramer acetate (GA) is a measurably better therapy than either agent used individually in patients with relapsing-remitting (RR) multiple sclerosis (MS).

It had three arms (groups): Interferon beta 1-a (active comparator), glatiramer acetate (active comparator) and IFN and GA (active comparator).

Active Interferon B1a Weekly vs. Placebo Glatiramer Acetate Interferon b-1a (IFN) intramuscularly weekly.

Active Interferon B1a Weekly and Active Glatiramer Acetate.

The registry classes the interventions as drug and other.

More on the Plan

This is a multicenter, double blind, randomized trial examining combination therapy versus single agent therapy with three-year follow-up on the last patient randomized.

All patients will remain on therapy until the last patient completes the study.

All patients will then be transitioned, based on the findings, to open label of combination with continued follow-up or some recommendation about single agent therapy.

Therefore, a two-group combination versus single agent concept was used - splitting the population into single agent and combination therapy equally.

Who Took Part

The registry lists 1008 actual participants took part.

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: Male and female subjects between the ages of 18 and 60 years, inclusive. Diagnosis of relapsing-remitting MS by either the Poser or McDonald criteria. Expanded Disability Status Scale (EDSS) score between 0 and 5.5, inclusive. Give written informed consent prior to any testing under this protocol, including screening tests and evaluations that are not considered part of the subject's routine care.

The full record lists 5 inclusion and 24 exclusion criteria; among the exclusions: any prior use of interferon beta or glatiramer acetate; acute exacerbation within 30 days of screening; evidence of progressive ms.

How the Study Was Run

Design: randomized, factorial 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.

Neither the multiple sclerosis participants nor the staff measuring them knew who was on Glatiramer Acetate, so expectations could not easily colour the readings.

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

It started in 2005-01 with completion listed for 2012-04.

It ran at 71 sites in United States (67) and Canada (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: ARR - PDEs (time frame: Baseline to Month 36).

It also tracked 3 secondary outcomes, for example Confirmed Progression on the Expanded Disability Status Scale, Change in the Multiple Sclerosis Functional Composite and Change in MRI Composite Score.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Glatiramer Acetate in 1008 people with multiple sclerosis.

With 1008 participants it is a large trial for this field.

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.