Safety of New Formulation of Glatiramer Acetate
An Open-Label, Multicenter, Randomized Study Evaluating the Tolerability and Safety of Two Formulations of Glatiramer Acetate (GA) for Subcutaneous Injection
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Experimental Glatiramer Acetate
Compared with
- Glatiramer acetate
Unknown
Results by group
Subject-reported Pain Associated Immediately After Each Injection
5 weeks of injections
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| F1 Glatiramer Acetate (GA) 20mg/1.0ml | 11.89 Scores on a scale | 14.325 (Standard Deviation) | 144 |
| F2 Glatiramer Acetate 20mg/0.5ml | 8.64 Scores on a scale | 10.825 (Standard Deviation) | 144 |
F1 Glatiramer Acetate (GA) 20mg/1.0ml
F2 Glatiramer Acetate 20mg/0.5ml
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| F1 Glatiramer Acetate (GA) 20mg/1.0ml | 147 | 0 (0.0%) | |
| F2 Glatiramer Acetate 20mg/0.5ml | 147 | 0 (0.0%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Subject-reported Pain Associated Immediately After Each Injection
5 weeks of injections
Pain
Other measures (1)
Degree of Pain Within 5 Mins After Injection
5 weeks of injections
Pain
Who could take part
Relapsing MS · 18 and over
Show the full criteria
Inclusion criteria
* Subjects ≥ 18 years of age with a diagnosis of RRMS * Currently injecting GA 20mg/1.0mL per day subcutaneously (SC) for a minimum of 90 days utilizing the autoject®2 for glass syringe or by a manual injection technique * Willing to switch from autoject®2 for glass syringe to manual injection technique or continue with a manual injection technique during the course of the study * Willing and able to be trained on a seven site injection rotation. Subject must be willing to comply with a minimum five injection site rotation plan during the study * Willing and able to complete all procedures and evaluations related to the study * Willing to continue to follow usual injection site preparation and routine adjunctive LISR management techniques * Willing and able to provide written informed consent
Exclusion criteria
* Currently using or treated with another immunomodulating therapy (IMT) in conjunction with GA in the 30 days prior to screening for this study * Currently using intermittent or pulse courses of corticosteroids by any route of administration in the 30 days prior to screening for this study. (Corticosteroids are prohibited for the duration of the study.) * Currently using an investigational drug or using treatment with any other investigational agent in the 30 days prior to screening for this study * Presence or history of skin necrosis * Known extensive dermatological condition that could be a confounding factor * Pregnant or planning pregnancy or breastfeeding * Any physical condition that impairs ability to be injected at the minimum of five sites rotation * Not able or willing to complete a daily diary * Use of any other parenteral medications (e.g., intramuscular, SC, intravenous, etc.) either currently or in the past 30 days prior to screening for this study * Any other medical or psychiatric conditions that would make the subject unsuitable for this research, as determined by the Investigator * Previous participation in this study
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of this study is to compare pain associated with injections and injection-site reactions of the approved formulation of Glatiramer Acetate (GA) versus investigational formulation of GA. In addition, the investigators will evaluate the side effects of the two formulations of GA.
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History
Started
Jul 2009
Main results due
Sept 2009
Finished
Nov 2009
Results posted
Jun 2011