Trial Outcomes & Findings for Evaluation of Two Glatiramer Acetate (GA) Formulations in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients (NCT NCT01167426)

Last Updated: 2013-10-17

Results Overview

The Satisfaction with Injection Experience questionnaire consists of 5 questions where participants are asked to rate their injection experience over the past 2 weeks on ease of use, bother, acceptability, confidence to inject and satisfaction. The response options range from "strongly disagree" (score = 1) to "strongly agree" (score = 5). The composite score of Satisfaction with Injection Experience is defined as the mean of the five Likert questions. The composite score ranges from 1.0 to 5.0, with a score of 5.0 representing the most satisfaction with injection experience and a score of 1.0 representing the least satisfaction with injection experience.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

148 participants

Primary outcome 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).

Results posted on

2013-10-17

Participant Flow

Participant milestones

Participant milestones
Measure	Glatiramer Acetate Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1), followed by 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).
Overall Study STARTED	148
Overall Study COMPLETED	138
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Glatiramer Acetate Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1), followed by 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).
Overall Study Lost to Follow-up	6
Overall Study Protocol Violation	1
Overall Study Withdrawal by Subject	2
Overall Study Sponsor Decision	1

Baseline Characteristics

Evaluation of Two Glatiramer Acetate (GA) Formulations in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Glatiramer Acetate n=148 Participants Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1), followed by 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	140 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age Continuous	48.1 years STANDARD_DEVIATION 10.29 • n=5 Participants
Sex: Female, Male Female	126 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	144 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized White	141 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	3 participants n=5 Participants
Race/Ethnicity, Customized Other	4 participants n=5 Participants
Region of Enrollment United States	148 participants n=5 Participants
Duration of Glatiramer Acetate	4.823 years STANDARD_DEVIATION 3.5539 • n=5 Participants
Duration of Multiple Sclerosis Disease	10.167 years STANDARD_DEVIATION 9.0643 • n=5 Participants

PRIMARY outcome

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).

Population: The Analysis Population consisted of of all patients who received at least one dose of study medication and had satisfaction data at time points 2 and 6 weeks, 2 and 4 weeks, or 2, 4 and 6 weeks.

Outcome measures

Outcome measures
Measure	Glatiramer Acetate n=139 Participants Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1), followed by 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).
Change From Week 2 to Week 6 in Composite Score of Patient Satisfaction With Injection Experience Week 2	4.1 units on a scale Standard Deviation 0.77
Change From Week 2 to Week 6 in Composite Score of Patient Satisfaction With Injection Experience Week 6	4.8 units on a scale Standard Deviation 0.46
Change From Week 2 to Week 6 in Composite Score of Patient Satisfaction With Injection Experience Change from Week 2 to Week 6	0.7 units on a scale Standard Deviation 0.79

SECONDARY outcome

Timeframe: Week 4

Population: Analysis Population with available data.

The Injection Experience Preference Questionnaire utilizes a 5-level preference scale where participants were asked to compare their injection experience during the first 2 weeks (glatiramer acetate 20 mg/1 mL) with the past 2 weeks (glatiramer acetate 20 mg/0.5 mL). Response options were: 1. "strongly prefer first experience (first 2 weeks)"; 2. "somewhat prefer first experience (first 2 weeks)"; 3. "no preference"; 4. "somewhat prefer second experience (past 2 weeks)"; 5. "strongly prefer second experience (past 2 weeks)." Responses 1 and 2 were combined into a single category (prefers first experience) and responses 4 and 5 were combined into a single category (prefers second experience).

Outcome measures

Outcome measures
Measure	Glatiramer Acetate n=140 Participants Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1), followed by 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).
Patient Injection Experience Preference Prefers First Experience	9 participants 6.2
Patient Injection Experience Preference No Preference	22 participants
Patient Injection Experience Preference Prefers Second Experience	109 participants

Adverse Events

Period 1: Glatiramer Acetate 20 mg/1.0 mL

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Period 2: Glatirimer Actetate

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Period 1: Glatiramer Acetate 20 mg/1.0 mL n=148 participants at risk Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1).	Period 2: Glatirimer Actetate n=142 participants at risk Participants received once daily subcutaneous administration of glatiramer acetate 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).
General disorders Injection site reaction	0.00% 0/148 All patients who receive at least 1 dose of study medication were included in the Safety population. 148 patients were exposed to the 20 mg/1.0 mL formulation of glatiramer acetate utilizing the autoject 2 for glass syringe and 142 patients were exposed to the 20 mg/0.5 mL formulation utilizing the autoject 2 20 mg/0.5 mL device.	7.7% 11/142 All patients who receive at least 1 dose of study medication were included in the Safety population. 148 patients were exposed to the 20 mg/1.0 mL formulation of glatiramer acetate utilizing the autoject 2 for glass syringe and 142 patients were exposed to the 20 mg/0.5 mL formulation utilizing the autoject 2 20 mg/0.5 mL device.

Additional Information

Thomas Smith, MD

Teva Pharmaceuticals Medical Affairs

Phone: 816-508-5128

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data
Publication restrictions are in place

Restriction type: OTHER