ENCORE
What it found
The main measure showed a statistically significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Change From Week 2 to Week 6 in Composite Score of Patient Satisfaction With Injection Experience | Difference in mean ranks 79.6 | <0.0001 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- Glatiramer acetate
Unknown
Results by group
Change From Week 2 to Week 6 in Composite Score of Patient Satisfaction With Injection Experience
Week 2 (prior to first injection with 20 mg/0.5 mL formulation), Week 6 (after 4 weeks of treatment with 20 mg/0.5 mL formulation).
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Glatiramer Acetate | 4.1 units on a scale | 0.77 (Standard Deviation) | 139 |
| Glatiramer Acetate | 4.8 units on a scale | 0.46 (Standard Deviation) | 139 |
| Glatiramer Acetate | 0.7 units on a scale | 0.79 (Standard Deviation) | 139 |
Glatiramer Acetate
Glatiramer Acetate
Glatiramer Acetate
p = <0.0001; Difference in mean ranks 79.6
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Period 1: Glatiramer Acetate 20 mg/1.0 mL | 148 | 0 (0.0%) | |
| Period 2: Glatirimer Actetate | 142 | 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
Change From Week 2 to Week 6 in Composite Score of Patient Satisfaction With Injection Experience
Week 2 (prior to first injection with 20 mg/0.5 mL formulation), Week 6 (after 4 weeks of treatment with 20 mg/0.5 mL formulation).
Quality of life (reported by participants)Feasibility
Other measures (1)
Patient Injection Experience Preference
Week 4
Who could take part
Relapsing MS · 18 and over
Inclusion Criteria: * Patients ≥ 18 years of age with a diagnosis of Relapse Remitting Multiple Sclerosis (RRMS) or Clinically Isolated Syndrome (CIS) * Currently injecting glatiramer acetate 20 mg/1.0 mL per day subcutaneously (SC) for a minimum of 90 days utilizing the autoject 2 for glass syringe for a minimum of 75% of daily injections * 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 local injection site reactions (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 an investigational drug or using treatment with any other investigational agent in the 30 days prior to screening for this study * Pregnant or planning pregnancy or breastfeeding * 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 patient unsuitable for this research, as determined by the Investigator * Unwilling to perform all daily injections with an autoject 2 device * Previous participation in any study evaluating the new 20 mg/0.5 mL formulation
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This is an open-label, multicenter study conducted at approximately 20 sites. Each patient will inject GA daily for 6 weeks utilizing an autoject 2 device to determine overall injection satisfaction.
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History
Started
Jul 2010
Main results due
Nov 2010
Finished
Dec 2010
Results posted
Oct 2013
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