MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone

What Was Tested

The trial (phase 3) is built around Glatiramer Acetate for multiple sclerosis.

It had three arms (groups): one (experimental), one (experimental) and one (active comparator).

Orally once daily.

Orally once daily.

Subcutaneous once daily.

The registry classes the interventions as drug.

More on the Plan

Randomization to either treatment group was preformed at visit 1 after a diligent check of applicable in- and exclusion criteria in a 1:1:1 ratio (changed to 5:3:2 after implementation of Amendment 2 in 2015).

Who Took Part

1064 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Written informed consent must be obtained before any assessment is performed. Male and female patients 18 to 65 years of age, inclusive. Patients with RRMS, as defined by 2010 revised McDonald criteria. Patients must be neurologically stable with no onset of relapse within 30 days of randomization. Patients with at least 1 documented relapse during the previous year or 2 documented relapses during the previous 2 years before randomization.

The full record lists 6 inclusion and 17 exclusion criteria; among the exclusions: patients who have been treated with:; immunosuppressive/chemotherapeutic medications (e.g., azathioprine, cyclophosphamide, methotrexate) within 6 months before randomization; natalizumab within 2 months before randomization.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The multiple sclerosis participants were allocated by chance, so the Glatiramer Acetate group and the comparison group should start out alike.

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 and outcomes assessor.

It started in 2012-08-09 with completion listed for 2018-04-30.

It ran at 130 sites in United States (101), Brazil (9), Mexico (8), Canada (7), Argentina (2) and Chile (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Confirmed Annualized Relapse Rate (time frame: up to 12 months).

It also tracked 8 secondary outcomes, for example New or Newly Enlarging T2 Lesions, Number of Participants Free of New/Newly Enlarged T2 Lesions, Change From Baseline in T2 Lesion Volume, Gd Enhancing T1 Lesion Count, Gd Enhancing T1 Lesion Volume and Percentage of Patients Free of New T1 Hypointense Lesions.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Glatiramer Acetate in 1064 people with multiple sclerosis.

With 1064 participants it is a large trial for this field.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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