A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Using Alcohol Wipes Prior to Daily Injections of Copaxone®.

What Was Tested

This registered phase 4 trial tested Glatiramer Acetate for multiple sclerosis.

This study is designed to compare injection site reactions with or without the use of alcohol wipes prior to performing the patients' daily Copaxone® injection.

It had two arms (groups): 1 (experimental) and 2 (experimental).

Injection site reactions with the use of alcohol wipes prior to performing the patients' daily Copaxone® injection.

Injection site reactions without the use of alcohol wipes prior to performing the patients' daily Copaxone® injection.

The registry classes the interventions as procedure.

Who Took Part

Enrollment: 50 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Male or Female. 18 years of age or older. Diagnosis of RRMS. Beginning or recently (within 3 months) began self-injecting Copaxone® subcutaneously.

The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: unable to perform subcutaneous self-injection; pregnant, or trying to become pregnant, or breast feeding during the study.

How the Study Was Run

The set-up was randomized, crossover and open-label.

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

In the crossover set-up each of the multiple sclerosis participants took both Glatiramer Acetate and the comparison in turn, acting as their own control.

Everyone knew when Glatiramer Acetate was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2004-08 with completion listed for 2005-10.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Total number of local injection site reactions (LISRs) noted at 5-minutes post-injection (time frame: four weeks of Period 1 and the four weeks of Period 2).

It also tracked 1 secondary outcome, for example The total number of LISRs noted at 2-minutes post-injection The total number of LISRs noted immediately after injection.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Glatiramer Acetate in 50 people with multiple sclerosis.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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