Trial · NCT01067521

A Study in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate (GA) Injection 40 mg Administered Three Times a Week Compared to Placebo

NCT01067521, Phase 3, Completed, Teva Branded Pharmaceutical Products R&D, Inc.; results first posted 2018-10-09

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate (GA) Injection 40 mg Administered Three Times a Week Compared to Placebo. Trials, record NCT01067521. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01067521

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate (GA) Injection 40 mg Administered Three Times a Week Compared to Placebo
NCT number: NCT01067521
Status: Completed
Phases: Phase 3
Enrollment: 1,404 participants, actual
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Conditions: Relapsing Remitting Multiple Sclerosis
Interventions: Glatiramer acetate (GA), Placebo
First posted: 2010-02-11
Last updated: 2021-12-09
Other registries' IDs: eudract:2009-018084-27
Results first posted: 2018-10-09
Limitations and caveats: Analyses of Open-Label Period data are not adjusted for multiplicity and therefore do not control for type one statistical error.

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Total Number of Confirmed Relapses During the Placebo Controlled (PC) Treatment Period Estimated by Negative Binomial Regression	Day 1 to 12 months	Relapses were monitored throughout the study. During the PC Period, two neurologists/physicians assessed subjects' general medical and neurological evaluations separately. A relapse was defined as the appearance of 1+ new neurological abnormalities or the reappearance of 1+ previously observed neurological abnormalities lasting \>= 48 hours and immediately preceded by an improving neurological state of at \>=30 days from onset of previous relapse. An event was counted as a relapse only when the subject's symptoms were accompanied by observed objective neurological changes, consistent with \>= one of the following: - An increase of \>= 0.5 in the Expanded Disability Status Scale (EDSS) score as compared to previous evaluation. - An increase of one grade in the actual score of \>=2 of the 7 functional systems (FS), as compared to previous evaluation. - An increase of 2 grades in the actual score of one FS as compared to the previous evaluation. Adjusted mean values are displayed.
Primary	Annualized Rate of Confirmed Relapses Comparing Early Starters to Delayed Starters Estimated by Negative Binomial Regression	Day 1 up to 6.5 years	The annualized relapse rate (ARR) was calculated for the study by dividing the cumulative number of confirmed relapses by the number of person-years of exposure to treatment. The analysis of the annualized relapse rate is based on estimating a contrast (early start vs delayed start) derived from a baseline-adjusted, Negative Binomial Regression model to the number of confirmed relapses observed during study (post randomization) with an "offset" based on the log of exposure to treatment.
Secondary	The Cumulative Number of New/Enlarging T2 Lesions Taken at Month 6 and Month 12 During the Placebo Controlled (PC) Treatment Period Estimated by Negative Binomial Regression	Baseline (Day -7), Month 6, Month 12	T2 lesions are hyperintense brain lesions that show on magnetic resonance imaging (MRI) and are associated with multiple sclerosis. The cumulative number of T2 lesions at Months 6 and 12 that are new or enlarged as compared to the baseline MRI are offered. Note that the two timeframes (Months 6 and 12) are combined. Adjusted mean is based on negative binomial regression, adjusted for baseline number of T2 lesions and country or geographical region as covariates.
Secondary	The Cumulative Number of Gadolinium (Gd)-Enhanced Lesions on T1-Weighted Images At Month 6 and Month 12 of the Placebo-Controlled (PC) Treatment Period Estimated by Negative Binomial Regression	Baseline (Day -7), Month 6, Month 12	The cumulative number of gadolinium (Gd)-enhanced lesions on T1-weighted images at Months 6 and 12 as compared to the baseline MRI are offered. Note that the two timeframes (Months 6 and 12) are combined. Adjusted mean is based on negative binomial regression with an "offset" employing the log of the proportion of the number of the available post-baseline scans to adjust for missing MRI scans (if any), adjusted for baseline number of enhancing lesions on T1-weighted images and country or geographical region as covariates.
Secondary	Brain Atrophy As Defined by the Percent of Change in Normalized Brain Volume From Baseline to Month 12 During the Placebo Controlled (PC) Treatment Period	Baseline (Day -7), Month 12	The analysis of brain atrophy as defined by the percentage change in normalized brain volume from baseline to Month 12 was based on the outcome of a contrast (GA 40 mg TIW vs. placebo) derived from a baseline-adjusted ANCOVA. In addition to the treatment group, the model included the following covariates: - SIENAX normalized brain volume at baseline. - The number of enhancing lesions on T1-weighted images at baseline. - country or geographical region. Sienax estimates total brain tissue volume, from a single image, normalised for skull size.
Secondary	The Number of New/Enlarging T2 Lesions at Months 6, 12 and 36 Estimated by Negative Binomial Regression	Baseline (Day -7), Month 6, Month 12, Month 36	All data accumulated from screening, the PC Treatment period up to the end of the Open Label (OL) period are combined and referred to as the Long Term Period. T2 lesions are hyperintense brain lesions that show on magnetic resonance imaging (MRI) and are associated with multiple sclerosis. The number of T2 lesions at Months 6, 12 and 36 that are new or enlarged as compared to the baseline MRI are offered. Adjusted mean is based on negative binomial regression, adjusted for baseline number of T2 lesions and country or geographical region as covariates. An "offset" employing the log of the proportion of the number of the available post-placebo-controlled baseline (PCBL) scans was used to adjust for missing MRI scans.
Secondary	The Cumulative Number of Gadolinium (Gd)-Enhanced Lesions on T1-Weighted Images At Months 6, 12 and 36 Estimated by Negative Binomial Regression	Baseline (Day -7), Month 6, Month 12, Month 36	All data accumulated from screening, the PC Treatment period up to the end of the Open Label (OL) period are combined and referred to as the Long Term Period. The cumulative number of gadolinium (Gd)-enhanced lesions on T1-weighted images at Months 6, 12 and 36 as compared to the baseline MRI are offered. Adjusted mean is based on negative binomial regression The model was fit using an autoregressive covariance structure. Covariates used: number of enhancing lesions on T1-weighted images at placebo-controlled baseline and country or geographical region. The cumulative number is derived from all the data points before it. For example, if the participant skipped one time point in between the baseline and 36 months, then it cannot be calculated.
Secondary	Brain Atrophy As Defined by the Percent of Change in Brain Volume From Baseline to Months 6, 12 and 36 Estimated by a Mixed Model for Repeated Measures	Baseline (Day -7), Month 6, Month 12, Month 36	The analysis of brain atrophy as defined by the percentage change in brain volume from baseline to Months 6, 12 and 36 was performed using mixed model for repeated measures (MMRM) with SIENAX normalized brain volume at baseline, number of Gd-enhancing lesions at baseline, and country or geographical region as fixed effects. Sienax estimates total brain tissue volume, from a single image, normalised for skull size.
Secondary	Participants With Treatment-Emergent Adverse Events (TEAEs)	Early Start: Day 1 up to 6.5 years Delayed Start - Placebo: Day 1 up to Month 12 Delayed Start - GA: Month 13 up to 6.5 years	Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Total Number of Confirmed Relapses During the Placebo Controlled (PC) Treatment Period Estimated by Negative Binomial Regression	Day 1 to 12 months	Intent To Treat (ITT) Analysis Population	confirmed relapses	MEAN
SECONDARY	The Cumulative Number of New/Enlarging T2 Lesions Taken at Month 6 and Month 12 During the Placebo Controlled (PC) Treatment Period Estimated by Negative Binomial Regression	Baseline (Day -7), Month 6, Month 12	ITT. When a subject had both Month 6 and Month 12 scans missing, the subject was excluded from the analysis. When the Month 12 scan was missing, data from Month 6 was used and an offset of log (0.5) introduced. When the Month 6 scan was missing, data from Month 12 was used with an offset of 0.	lesions	MEAN
SECONDARY	The Cumulative Number of Gadolinium (Gd)-Enhanced Lesions on T1-Weighted Images At Month 6 and Month 12 of the Placebo-Controlled (PC) Treatment Period Estimated by Negative Binomial Regression	Baseline (Day -7), Month 6, Month 12	ITT. When a subject had both Month 6 and Month 12 scans missing, the subject was excluded from the analysis.	lesions	MEAN
SECONDARY	Brain Atrophy As Defined by the Percent of Change in Normalized Brain Volume From Baseline to Month 12 During the Placebo Controlled (PC) Treatment Period	Baseline (Day -7), Month 12	ITT population of participants who had SIENEX brain volume estimates at both baseline and Month 12.	percentage change	MEAN
PRIMARY	Annualized Rate of Confirmed Relapses Comparing Early Starters to Delayed Starters Estimated by Negative Binomial Regression	Day 1 up to 6.5 years	ITT	relapses per year	MEAN
SECONDARY	The Number of New/Enlarging T2 Lesions at Months 6, 12 and 36 Estimated by Negative Binomial Regression	Baseline (Day -7), Month 6, Month 12, Month 36	ITT population of participants with MRIs at both baseline and the designated timeframes.	lesions	MEAN
SECONDARY	The Cumulative Number of Gadolinium (Gd)-Enhanced Lesions on T1-Weighted Images At Months 6, 12 and 36 Estimated by Negative Binomial Regression	Baseline (Day -7), Month 6, Month 12, Month 36	ITT population of participants with MRIs at both baseline and the designated timeframes, inclusive of the proceeding post-baseline timeframes.	lesions	MEAN
SECONDARY	Brain Atrophy As Defined by the Percent of Change in Brain Volume From Baseline to Months 6, 12 and 36 Estimated by a Mixed Model for Repeated Measures	Baseline (Day -7), Month 6, Month 12, Month 36	ITT population of participants with SIENEX brain scans at both baseline and the designated timeframes.	percentage change	MEAN
SECONDARY	Participants With Treatment-Emergent Adverse Events (TEAEs)	Early Start: Day 1 up to 6.5 years Delayed Start - Placebo: Day 1 up to Month 12 Delayed Start - GA: Month 13 up to 6.5 years	Glatiramer Acetate (GA) - Treated Analysis Set The GA-Treated analysis set includes all subjects randomized into the study and treated with at least 1 dose of GA at any time during the study. Analyses includes data collected for these subjects from the first time GA was administered.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group52

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Total Number of Confirmed Relapses During the Placebo Controlled (PC) Treatment Period Estimated by Negative Binomial Regression	Early Start: GA 40 mg / GA 40 mg	0.331	Standard Error 0.028	confirmed relapses
Total Number of Confirmed Relapses During the Placebo Controlled (PC) Treatment Period Estimated by Negative Binomial Regression	Delayed Start: Placebo / GA 40 mg	0.505	Standard Error 0.049	confirmed relapses
The Cumulative Number of New/Enlarging T2 Lesions Taken at Month 6 and Month 12 During the Placebo Controlled (PC) Treatment Period Estimated by Negative Binomial Regression	Early Start: GA 40 mg / GA 40 mg	3.650	Standard Error 0.259	lesions
The Cumulative Number of New/Enlarging T2 Lesions Taken at Month 6 and Month 12 During the Placebo Controlled (PC) Treatment Period Estimated by Negative Binomial Regression	Delayed Start: Placebo / GA 40 mg	5.592	Standard Error 0.490	lesions
The Cumulative Number of Gadolinium (Gd)-Enhanced Lesions on T1-Weighted Images At Month 6 and Month 12 of the Placebo-Controlled (PC) Treatment Period Estimated by Negative Binomial Regression	Early Start: GA 40 mg / GA 40 mg	0.905	Standard Error 0.087	lesions
The Cumulative Number of Gadolinium (Gd)-Enhanced Lesions on T1-Weighted Images At Month 6 and Month 12 of the Placebo-Controlled (PC) Treatment Period Estimated by Negative Binomial Regression	Delayed Start: Placebo / GA 40 mg	1.639	Standard Error 0.194	lesions
Brain Atrophy As Defined by the Percent of Change in Normalized Brain Volume From Baseline to Month 12 During the Placebo Controlled (PC) Treatment Period	Early Start: GA 40 mg / GA 40 mg	-0.706	Standard Error 0.037	percentage change
Brain Atrophy As Defined by the Percent of Change in Normalized Brain Volume From Baseline to Month 12 During the Placebo Controlled (PC) Treatment Period	Delayed Start: Placebo / GA 40 mg	-0.645	Standard Error 0.047	percentage change
Annualized Rate of Confirmed Relapses Comparing Early Starters to Delayed Starters Estimated by Negative Binomial Regression	Early Start: GA 40 mg / GA 40 mg	0.2621	Standard Error 0.0189	relapses per year
Annualized Rate of Confirmed Relapses Comparing Early Starters to Delayed Starters Estimated by Negative Binomial Regression	Delayed Start: Placebo / GA 40 mg	0.3146	Standard Error 0.0279	relapses per year

1 to 10 of 52Source ClinicalTrials.gov

See all 52 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Double-Blind Placebo-Controlled Period	STARTED	Early Start: GA 40 mg / GA 40 mg	943
Double-Blind Placebo-Controlled Period	STARTED	Delayed Start: Placebo / GA 40 mg	461
Double-Blind Placebo-Controlled Period	COMPLETED	Early Start: GA 40 mg / GA 40 mg	859
Double-Blind Placebo-Controlled Period	COMPLETED	Delayed Start: Placebo / GA 40 mg	430
Double-Blind Placebo-Controlled Period	NOT COMPLETED	Early Start: GA 40 mg / GA 40 mg	84
Double-Blind Placebo-Controlled Period	NOT COMPLETED	Delayed Start: Placebo / GA 40 mg	31
Open-Label Period	STARTED	Early Start: GA 40 mg / GA 40 mg	834
Open-Label Period	STARTED	Delayed Start: Placebo / GA 40 mg	419
Open-Label Period	COMPLETED	Early Start: GA 40 mg / GA 40 mg	580
Open-Label Period	COMPLETED	Delayed Start: Placebo / GA 40 mg	261

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events714

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Injection site erythema	General disorders	Delayed Start: GA 40 mg	107	419	122
other	Injection site erythema	General disorders	Delayed Start: Placebo	8	461	10
other	Injection site erythema	General disorders	Early Start: GA 40 mg / GA 40 mg	243	943	391
other	Injection site pain	General disorders	Delayed Start: GA 40 mg	55	419	61
other	Injection site pain	General disorders	Delayed Start: Placebo	10	461	10
other	Injection site pain	General disorders	Early Start: GA 40 mg / GA 40 mg	115	943	138
other	Injection site pruritus	General disorders	Delayed Start: GA 40 mg	23	419	24
other	Injection site pruritus	General disorders	Delayed Start: Placebo	2	461	2
other	Injection site pruritus	General disorders	Early Start: GA 40 mg / GA 40 mg	68	943	95
other	Injection site swelling	General disorders	Delayed Start: GA 40 mg	23	419	23

1 to 10 of 714Source ClinicalTrials.gov

See all 714 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Delayed Start: GA 40 mg	1	419
Total, all-cause mortality	Delayed Start: Placebo	1	461
Total, all-cause mortality	Early Start: GA 40 mg / GA 40 mg	3	943
Total, other adverse events	Delayed Start: GA 40 mg	238	419
Total, other adverse events	Delayed Start: Placebo	167	461
Total, other adverse events	Early Start: GA 40 mg / GA 40 mg	609	943
Total, serious adverse events	Delayed Start: GA 40 mg	36	419
Total, serious adverse events	Delayed Start: Placebo	21	461
Total, serious adverse events	Early Start: GA 40 mg / GA 40 mg	117	943

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
27503905	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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