Phase II Study of Teriflunomide as Adjunctive Therapy to Glatiramer Acetate in Subjects With Multiple Sclerosis

What Was Tested

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

It had three arms (groups): Placebo + GA (placebo comparator), one (experimental) and one (experimental).

Placebo (for teriflunomide) once daily concomitantly with glatiramer acetate (GA) for 24 weeks.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 123 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: Definite MS diagnosis according to McDonald's criteria;. Relapsing clinical course, with or without progression;. Expanded Disability Status Scale \[EDSS\] less or equal to 5.5 (ambulatory);. No onset of MS relapse in the preceding 60 days prior to randomization;. Clinically stable for 4 weeks prior to randomization.

The full record lists 6 inclusion and 6 exclusion criteria; among the exclusions: other chronic disease of the immune system, liver function impairment or chronic pancreatic disease;; pregnant or nursing woman;; alcohol or drug abuse;.

How the Study Was Run

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

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.

Blinding on both sides kept the multiple sclerosis participants and researchers unaware of who received Glatiramer Acetate.

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

It started in 2007-04 with completion listed for 2009-10.

It ran at 6 sites in United States (1), Austria (1), Canada (1), Germany (1), Italy (1) and United Kingdom (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Overview of Adverse Events (AE]. Overview of AE With Potential Risk of Occurrence.

It also tracked 5 secondary outcomes, for example Cerebral Magnetic Resonance Imaging [MRI] Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease), Cerebral MRI Assessment: Number of Gd-enhancing T1-lesions Per Scan (Poisson Regression Estimates), Cerebral MRI Assessment: Volume of Gd-enhancing T1-lesions Per Scan and Annualized Relapse Rate [ARR]: Poisson Regression Estimates.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Glatiramer Acetate in 123 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.