Long Term Safety of Teriflunomide When Added to Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis

What Was Tested

The trial (phase 2) is built around Glatiramer Acetate for multiple sclerosis.

The primary objective was to evaluate the long-term safety and tolerability of teriflunomide when added to treatment with interferon-β \[IFN-β\] or glatiramer Acetate \[GA\] in patients with multiple sclerosis \[MS\] with relapses.

Secondary objectives were to evaluate the long-term effect on relapse rate, disability progression and Magnetic Resonance Imaging \[MRI\] parameters.

This study is the extension study of the PDY6045 (NCT00489489) and PDY6046 (NCT00475865) studies.

It had six arms (groups): Placebo + IFN-β (placebo comparator), one (experimental), one (experimental), Placebo + GA (placebo comparator) and one (experimental).

Placebo (for teriflunomide) once daily concomitantly with interferon-β \[IFN-β\] for 24 additional weeks.

The registry classes the interventions as drug.

More on the Plan

The duration of the extension study per participants was 40 weeks broken down as follows: * 24-week double-blind treatment period, * 16-week post-treatment elimination follow-up period.

Who Took Part

The registry lists 182 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: PDY6045 or PDY6046 participant who:. Completed the week 24 visit of either study PDY6045 or PDY6046,. Was still meeting eligibility criteria for receiving treatment,.

The full record lists 4 inclusion and 1 exclusion criteria.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

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.

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

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

It started in 2007-10 with completion listed for 2010-04.

It ran at 7 sites in United States (1), Austria (1), Canada (1), Germany (1), Italy (1) and Spain (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Overview of Adverse Events [AE].

It also tracked 6 secondary outcomes, for example Annualized Relapse Rate [ARR]: Poisson Regression Estimates, Overview of 12-week Sustained Disability Progression, Time to 12-week Sustained Disability Progression: Kaplan-Meier Estimates of the Rate of Disability Progression at Timepoints, 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) and Cerebral MRI Assessment: Total Volume of Gd-enhancing T1-lesions Per Scan.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Glatiramer Acetate in 182 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.