Phase 3
Completed N=148
Evaluation of Two Glatiramer Acetate (GA) Formulations in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients
Source: ClinicalTrials.gov NCT01167426 ↗Enrolled (actual)
148
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcomePrimary: Change From Week 2 to Week 6 in Composite Score of Patient Satisfaction With Injection Experience — 4.1; 4.8; 0.7 units on a scale — p=<0.0001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Week 2 to Week 6 in Composite Score of Patient Satisfaction With Injection Experience |
4.1; 4.8; 0.7 | <0.0001 sig |
| SECONDARY Patient Injection Experience Preference |
9; 22; 109 | <0.0001 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01167426). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.