Multiple SclerosisPhase 3ENCORENCT01167426
Evaluation of Two Glatiramer Acetate (GA) Formulations in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients
A Phase 3 study testing Glatiramer Acetate 20 mg/0.5 mL in people with Multiple Sclerosis, run by Teva Neuroscience, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Glatiramer Acetate 20 mg/0.5 mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Dec 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Glatiramer Acetate 20 mg/0.5 mL
- Keywords
- Relapsing Remitting Multiple Sclerosis, RRMS, Clinically Isolated Syndrome, CIS, Copaxone, glatiramer acetate, Autoject 2
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glatiramer Acetate 20 mg/0.5 mLDrug
Also called Copaxone®
20 mg/1.0 mL formulation of glatiramer acetate utilizing the autoject 2 for glass syringe.
Glatiramer acetate 20 mg/0.5 mLDrug
20 mg/0.5 mL formulation of glatiramer acetate utilizing the autoject 2 20 mg/0.5 mL device.
| Study group | Role | What they receive |
|---|---|---|
| 20 mg/0.5 mL Glatiramer Acetate | Active comparator | 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). Receives: Drug: Glatiramer Acetate 20 mg/0.5 mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Week 2 to Week 6 in Composite Score of Patient Satisfaction With Injection Experience
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.
Measured: 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 (1)
Patient Injection Experience Preference
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).
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionNov 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Neuroscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tom Smith, MD, Study director, Teva Neuroscience, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167426
- Sponsor's protocol ID
- PM034
- Acronym
- ENCORE
- Status last verified
- Aug 2012
- First submitted
- 20 Jul 2010
- Last updated
- 17 Oct 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01167426
- Acronym / sponsor ID
- ENCORE / PM034
- Conditions
- Multiple Sclerosis
- Keywords
- Relapsing Remitting Multiple Sclerosis, RRMS, Clinically Isolated Syndrome, CIS, Copaxone, glatiramer acetate, Autoject 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Teva Neuroscience, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 22 Jul 2010 (estimated)
- Results
- Posted 17 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 20 mg/0.5 mL Glatiramer Acetate | Active comparator | Drug: Glatiramer Acetate 20 mg/0.5 mLParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glatiramer Acetate 20 mg/0.5 mLAlso: Copaxone®20 mg/1.0 mL formulation of glatiramer acetate utilizing the autoject 2 for glass syringe. | Drug | 20 mg/0.5 mL Glatiramer Acetate |
| Glatiramer acetate 20 mg/0.5 mL20 mg/0.5 mL formulation of glatiramer acetate utilizing the autoject 2 20 mg/0.5 mL device. | Drug | 20 mg/0.5 mL Glatiramer Acetate |
Primary outcome
Change From Week 2 to Week 6 in Composite Score of Patient Satisfaction With Injection Experience
Time frame: 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).
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.
1 secondary outcome
Patient Injection Experience Preference
Time frame: Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Smith, MD study director
Teva Neuroscience, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Glatiramer Acetate 20 mg/0.5 mL in people with Multiple Sclerosis, run by Teva Neuroscience, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Week 2 to Week 6 in Composite Score of Patient Satisfaction With Injection Experience (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2013.