Trial · NCT00337779

Clinical Trial Comparing Treatment of Relapsing-Remitting Multiple Sclerosis (RR-MS) With Two Doses of Glatiramer Acetate (GA).

NCT00337779, Phase 3, Completed, Teva Branded Pharmaceutical Products R&D, Inc.; results first posted 2010-05-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Clinical Trial Comparing Treatment of Relapsing-Remitting Multiple Sclerosis (RR-MS) With Two Doses of Glatiramer Acetate (GA). Trials, record NCT00337779. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00337779

On this page

Trial

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

Title: Clinical Trial Comparing Treatment of Relapsing-Remitting Multiple Sclerosis (RR-MS) With Two Doses of Glatiramer Acetate (GA).
NCT number: NCT00337779
Status: Completed
Phases: Phase 3
Enrollment: 1,155 participants, actual
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Conditions: Relapsing Remitting Multiple Sclerosis
Interventions: Glatiramer Acetate (GA) 40 mg, glatiramer acetate 20 mg
First posted: 2006-06-16
Last updated: 2011-10-10
Results first posted: 2010-05-14

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	The Rate of Confirmed Relapses During the Double-blind Phase (12 Months).	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.
Secondary	The Number of New T2 Lesions at Month 12 as Compared to the Baseline Scan.	12 months	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.
Secondary	The Cumulative Number of T1-Gd Enhancing Lesions at Months 3, 6, 9 and 12 (in the Frequent MRI Cohort-described Below).	12 months	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.

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Rate of Confirmed Relapses During the Double-blind Phase (12 Months).	12 months	ITT	Number of relapses per patient	MEAN
SECONDARY	The Number of New T2 Lesions at Month 12 as Compared to the Baseline Scan.	12 months		T2 Lesions	MEAN
SECONDARY	The Cumulative Number of T1-Gd Enhancing Lesions at Months 3, 6, 9 and 12 (in the Frequent MRI Cohort-described Below).	12 months	Frequent MRI cohort	T1 Enhancing Lesions	LOG_MEAN

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Value	Spread	Units
The Rate of Confirmed Relapses During the Double-blind Phase (12 Months).	Glatiramer Acetate 20 mg	0.28	Standard Deviation 0.58	Number of relapses per patient
The Rate of Confirmed Relapses During the Double-blind Phase (12 Months).	Glatiramer Acetate 40 mg	0.27	Standard Deviation 0.54	Number of relapses per patient
The Number of New T2 Lesions at Month 12 as Compared to the Baseline Scan.	Glatiramer Acetate 20 mg	2.87	Standard Deviation 6.57	T2 Lesions
The Number of New T2 Lesions at Month 12 as Compared to the Baseline Scan.	Glatiramer Acetate 40 mg	2.72	Standard Deviation 8.36	T2 Lesions
The Cumulative Number of T1-Gd Enhancing Lesions at Months 3, 6, 9 and 12 (in the Frequent MRI Cohort-described Below).	Glatiramer Acetate 20 mg	2.83	Standard Deviation 6.58	T1 Enhancing Lesions
The Cumulative Number of T1-Gd Enhancing Lesions at Months 3, 6, 9 and 12 (in the Frequent MRI Cohort-described Below).	Glatiramer Acetate 40 mg	3.49	Standard Deviation 8.19	T1 Enhancing Lesions

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Glatiramer Acetate 20 mg	586
Overall Study	STARTED	Glatiramer Acetate 40 mg	569
Overall Study	COMPLETED	Glatiramer Acetate 20 mg	534
Overall Study	COMPLETED	Glatiramer Acetate 40 mg	490
Overall Study	NOT COMPLETED	Glatiramer Acetate 20 mg	52
Overall Study	NOT COMPLETED	Glatiramer Acetate 40 mg	79

Source ClinicalTrials.gov

Adverse events186

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	Nausea	Gastrointestinal disorders	Glatiramer Acetate 20 mg	33	586	41
other	Nausea	Gastrointestinal disorders	Glatiramer Acetate 40 mg	33	569	45
other	Fatigue	General disorders	Glatiramer Acetate 20 mg	39	586	43
other	Fatigue	General disorders	Glatiramer Acetate 40 mg	41	569	44
other	Chest Discomfort	General disorders	Glatiramer Acetate 20 mg	32	586	43
other	Chest Discomfort	General disorders	Glatiramer Acetate 40 mg	28	569	33
other	Injection Erythema	General disorders	Glatiramer Acetate 20 mg	183	586	200
other	Injection Erythema	General disorders	Glatiramer Acetate 40 mg	196	569	231
other	Injection Site Bruising	General disorders	Glatiramer Acetate 20 mg	31	586	35
other	Injection Site Bruising	General disorders	Glatiramer Acetate 40 mg	21	569	22

1 to 10 of 186Source ClinicalTrials.gov

See all 186 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Glatiramer Acetate 20 mg
Total, all-cause mortality	Glatiramer Acetate 40 mg
Total, other adverse events	Glatiramer Acetate 20 mg	499	586
Total, other adverse events	Glatiramer Acetate 40 mg	490	569
Total, serious adverse events	Glatiramer Acetate 20 mg	25	586
Total, serious adverse events	Glatiramer Acetate 40 mg	24	569

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons1

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

Comparison
Glatiramer Acetate 20 mg vs Glatiramer Acetate 40 mg: serious adverse events

Source Trial comparisons

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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00337779

GET https://conductscience.org/api/trials/v1/NCT00337779/events?page=2

API reference For AI assistants