Relapsing Remitting Multiple SclerosisPhase 3NCT00337779
Clinical Trial Comparing Treatment of Relapsing-Remitting Multiple Sclerosis (RR-MS) With Two Doses of Glatiramer Acetate (GA).
A Phase 3 study testing Glatiramer Acetate (GA) 40 mg and glatiramer acetate 20 mg in people with Relapsing Remitting Multiple Sclerosis, run by Teva Branded Pharmaceutical Products R&D, Inc..
Trial summary
Teva is developing a 40 mg/ml GA Injection, administered once daily under the skin, for the treatment of R-R MS. The study drug is a higher dose formulation of Copaxone® (20 mg/ml GA), a marketed medication, approved for the treatment of R-R MS. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- Glatiramer Acetate (GA) 40 mg and glatiramer acetate 20 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,155 participants
- Where
- No sites listed yet
- Study dates
- Aug 2006to Oct 2008
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of confirmed and documented MS defined by the Revised McDonald criteria.
- Subjects must be of the relapsing-remitting (R-R) type.
- Subject has experienced prior to screening at least one documented relapse in 12 months or at least 2 documented relapses in the 24 months or one documented relapse between 12 - 24 months with at least 1 documented T1-Gd enhancing lesion in the MRI performed 12 months prior screening.
- Disease duration for at least 6 months.
- Ambulatory with converted Kurtzke EDSS score of 0 - 5.
- Relapse free and stable neurological condition at least for 30 days prior screening.
- Age - 18-55 (inclusive)
Who cannot join
- Previous use of Copaxone (glatiramer acetate)
- Treatment with corticosteroids within 30 days prior screening or between screening and baseline.
- Chronic corticosteroids treatment - more than 30 consecutive days.
- Subject with any clinically significant or unstable medical condition.
- Subjects participating in any other clinical trial (within 12 weeks prior to screening and thereafter).
- Known history of sensitivity to Gadolinium and inability to successfully undergo MRI scanning.
About this study
Official title: A Multinational, Multicenter, Randomized, Parallel-Group, Double-Blind Study to Compare the Efficacy, Tolerability and Safety of Glatiramer Acetate Injection 40 mg/ml to That of Glatiramer Acetate Injection 20 mg/ml Administered Once Daily by Subcutaneous Injection in Subjects With Relapsing Remitting (R-R) Multiple Sclerosis (MS)
Teva is developing a 40 mg/ml GA Injection, administered once daily under the skin, for the treatment of R-R MS. The study drug is a higher dose formulation of Copaxone® (20 mg/ml GA), a marketed medication, approved for the treatment of R-R MS. GA is an immunomodulating drug that has anti inflammatory and neuroprotective properties. The study treatment duration is 12 months.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- Glatiramer Acetate (GA) 40 mg, glatiramer acetate 20 mg
- Medical subject headings
- 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 (GA) 40 mgDrug
Also called Copaxone®
Glatiramer Acetate Injection 40 mg/ml Daily subcutaneous injection for 12 months
glatiramer acetate 20 mgDrug
Also called Copaxone®
Glatiramer Acetate Injection 20 mg/ml Daily subcutaneous injection for 12 months
| Study group | Role | What they receive |
|---|---|---|
| glatiramer acetate 40 mg | Active comparator | Not described Receives: Drug: Glatiramer Acetate (GA) 40 mg |
| glatiramer acetate 20 mg | Active comparator | Not described Receives: Drug: glatiramer acetate 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Rate of Confirmed Relapses During the Double-blind Phase (12 Months).
A confirmed relapse is defined as the appearance of one or more new neurological abnormalities or the reappearance of one or more previously observed neurological abnormalities. This change in clinical state must last at least 48 hours and be immediately preceded by an improving neurological state of at least thirty (30) days from onset of previous relapse.
Measured: 12 months
Secondary outcomes (2)
The Number of New T2 Lesions at Month 12 as Compared to the Baseline Scan.
The analysis of this endpoint was based on the outcome of a contrast derived from a baseline-adjusted Negative Binomial Regression including the number of T1 Gd-enhancing lesions at baseline, the volume of T2 lesions at baseline and (pooled) center as covariates.
Measured: 12 months
The Cumulative Number of T1-Gd Enhancing Lesions at Months 3, 6, 9 and 12 (in the Frequent MRI Cohort-described Below).
The Frequent MRI Cohort was a subset of subjects consisting of 234 subjects, for whom MRI scans were performed at months 0 (baseline), 1, 2, 3, 6, 9 and 12. Analysis of the endpoint was based on the outcome of a contrast derived from a baseline-adjusted Negative Binomial Regression with an "offset" variable employing the log of the porportion of the number of available post-baseline scans to adjust for missing MRI scans (if any) and including the number of T1 Gd-enhancing lesions at baseline and (pooled) center as covariates.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2006 (estimated)
- Study startAug 2006
- Primary completionOct 2008
- Study completionOct 2008
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 Relapsing Remitting 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chen Duksin, MD, Study chair, Teva Pharmaceutical Industries, Ltd.Giancarlo Comi, Prof, Principal investigator, Istituto Scientifico Fondazione Centro S. Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00337779
- Sponsor's protocol ID
- GA/9016 (FORTE)
- Status last verified
- Oct 2011
- First submitted
- 14 Jun 2006
- Last updated
- 10 Oct 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational, Multicenter, Randomized, Parallel-Group, Double-Blind Study to Compare the Efficacy, Tolerability and Safety of Glatiramer Acetate Injection 40 mg/ml to That of Glatiramer Acetate Injection 20 mg/ml Administered Once Daily by Subcutaneous Injection in Subjects With Relapsing Remitting (R-R) Multiple Sclerosis (MS)
- ClinicalTrials.gov ID
- NCT00337779
- Acronym / sponsor ID
- GA/9016 (FORTE)
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,155 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 16 Jun 2006 (estimated)
- Results
- Posted 14 May 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Teva is developing a 40 mg/ml GA Injection, administered once daily under the skin, for the treatment of R-R MS. The study drug is a higher dose formulation of Copaxone® (20 mg/ml GA), a marketed medication, approved for the treatment of R-R MS. GA is an immunomodulating drug that has anti inflammatory and neuroprotective properties. The study treatment duration is 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| glatiramer acetate 40 mg | Active comparator | Drug: Glatiramer Acetate (GA) 40 mg |
| glatiramer acetate 20 mg | Active comparator | Drug: glatiramer acetate 20 mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Diagnosis of confirmed and documented MS defined by the Revised McDonald criteria.
- Subjects must be of the relapsing-remitting (R-R) type.
- Subject has experienced prior to screening at least one documented relapse in 12 months or at least 2 documented relapses in the 24 months or one documented relapse between 12 - 24 months with at least 1 documented T1-Gd enhancing lesion in the MRI performed 12 months prior screening.
- Disease duration for at least 6 months.
- Ambulatory with converted Kurtzke EDSS score of 0 - 5.
Key exclusion criteria (6 listed)
- Previous use of Copaxone (glatiramer acetate)
- Treatment with corticosteroids within 30 days prior screening or between screening and baseline.
- Chronic corticosteroids treatment - more than 30 consecutive days.
- Subject with any clinically significant or unstable medical condition.
- Subjects participating in any other clinical trial (within 12 weeks prior to screening and thereafter).
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 (GA) 40 mgAlso: Copaxone®Glatiramer Acetate Injection 40 mg/ml Daily subcutaneous injection for 12 months | Drug | glatiramer acetate 40 mg |
| glatiramer acetate 20 mgAlso: Copaxone®Glatiramer Acetate Injection 20 mg/ml Daily subcutaneous injection for 12 months | Drug | glatiramer acetate 20 mg |
Primary outcome
The Rate of Confirmed Relapses During the Double-blind Phase (12 Months).
Time frame: 12 months
A confirmed relapse is defined as the appearance of one or more new neurological abnormalities or the reappearance of one or more previously observed neurological abnormalities. This change in clinical state must last at least 48 hours and be immediately preceded by an improving neurological state of at least thirty (30) days from onset of previous relapse.
2 secondary outcomes
The Number of New T2 Lesions at Month 12 as Compared to the Baseline Scan.
Time frame: 12 months
The Cumulative Number of T1-Gd Enhancing Lesions at Months 3, 6, 9 and 12 (in the Frequent MRI Cohort-described Below).
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2011.
- 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.
Chen Duksin, MD study chair
Teva Pharmaceutical Industries, Ltd.
Giancarlo Comi, Prof principal investigator
Istituto Scientifico Fondazione Centro S. Raffaele
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Glatiramer Acetate (GA) 40 mg and glatiramer acetate 20 mg in people with Relapsing Remitting Multiple Sclerosis, run by Teva Branded Pharmaceutical Products R&D, 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 7 inclusion and 6 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 10 Oct 2011. 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 14 May 2010). 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?
The Rate of Confirmed Relapses During the Double-blind Phase (12 Months). (time frame: 12 months). 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 10 Oct 2011.