Phase IV Study, Betaseron Versus Copaxone for Relapsing Remitting or CIS Forms of MS Using Triple Dose Gad 3 T MRI

What Was Tested

The trial (phase 4) is built around Glatiramer Acetate for multiple sclerosis.

It had two arms (groups): Betaseron (active comparator) and Copaxone (active comparator).

The registry classes the interventions as drug.

More on the Plan

The researchers propose to perform a head to head comparison of Interferon beta and Copaxone for treatment of patients with CIS and RR forms of MS using acute changes on MRI as primary outcome.

The researchers will examine the number of patients who remain "combined-active disease-free" for the duration of the study and the number of "combined-active disease-free" scans.

Apart from these traditional methods of analysis by a reader who will be blinded to patient clinical status and therapy, objective volumetric analysis will be carried out.

Another MRI outcome measures will be detection of diffusion anisotropy differences, MR spectroscopy, and magnetization transfer ratio as summarized in Appendix 5.

Who Took Part

The registry lists 75 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: Be Between 18 and 55 years of age, at baseline. Be available and willing to complete all study assessments. Presently meet one of the two following forms of multiple sclerosis:. At baseline, have an EDSS between 0-5.5. Females of childbearing potential must agree to practice adequate contraception methods. All females must have negative pregnancy test results at screening and a negative urine pregnancy test at baseline.

The full record lists 9 inclusion and 17 exclusion criteria; among the exclusions: onset of a relapse between screening and study day 1; present evidence or history of any conditions that could affect the cns or interfere with the mri results or any other evaluation in the study; possess any of the standard metallic devices or foreign bodies that are contraindications for mri.

How the Study Was Run

Design: randomized, parallel-group and single-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.

Only one side, usually the multiple sclerosis participants, was kept unaware of whether Glatiramer Acetate was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2003-01 with completion listed for 2007-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 2 secondary outcomes, for example The Number of Enhancing Lesions and The Number of MRI Disease Free Patients.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Glatiramer Acetate in 75 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.