Clinical trial NCT01167426: Evaluation of Two Glatiramer Acetate (GA) Formulations in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients
Official title: An Open-Label, Multicenter Study Evaluating Patient Injection Satisfaction With Two Formulations of Glatiramer Acetate (GA) Using Autoject 2 as the Subcutaneous Injection Delivery Method.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis
Keywords: Relapsing Remitting Multiple Sclerosis
RRMS
Clinically Isolated Syndrome
CIS
Copaxone
glatiramer acetate
Autoject 2
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2010-07-22
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief 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.

Detailed description: The study will consist of a 2 week treatment period with participants injecting their current therapy of Copaxone 20 mg/1.0 mL glatiramer acetate utilizing an autoject 2. All participants will then roll over to the new formulation of 20 mg/0.5 mL glatiramer acetate with an autoject 2 device for a 4 week treatment period. Patient satisfaction will be evaluated using an Experience Questionnaire throughout the study.

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

Primary outcomes:
measure: Change From Week 2 to Week 6 in Composite Score of Patient Satisfaction With Injection Experience
timeFrame: 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).
Secondary outcomes:
measure: Patient Injection Experience Preference
timeFrame: Week 4
Other outcomes:
Locations:
Study officials:
affiliation: Teva Neuroscience, Inc.
name: Tom Smith, MD
role: STUDY_DIRECTOR
References: