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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Teva Pharmaceutical Industries

ClinicalTrials.gov Identifier:

NCT00337779

First received: June 14, 2006

Last updated: October 6, 2011

Last verified: October 2011

History of Changes

Results First Received: January 18, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Relapsing Remitting Multiple Sclerosis
Interventions:	Drug: Glatiramer Acetate (GA) 40 mg Drug: glatiramer acetate 20 mg

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study was conducted according to laws, regulations and administrative provisions related to implementation of Good Clinical Practice as applicable by legislation directives and Standard Operating Procedures. Subjects entered study after being informed and given time to contemplate consent. Enrollment began September 2006 and completed May 2007

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All subjects underwent evaluations including vital signs (blood pressure, pulse, and temperature,) adverse events, concomitant medications and neurological evaluation prior to study entry.

Reporting Groups

	Description
Glatiramer Acetate 20 mg	No text entered.
Glatiramer Acetate 40 mg	No text entered.

Participant Flow: Overall Study

	Glatiramer Acetate 20 mg	Glatiramer Acetate 40 mg
STARTED	586	569
COMPLETED	534	490
NOT COMPLETED	52	79
Withdrawal by Subject	10	12
Sponsor decision	1	1
Physician Decision	3	6
Protocol Violation	1	1
Lost to Follow-up	6	5
Adverse Event	28	51
Pregnancy	3	2
Death	0	1

Baseline Characteristics

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Reporting Groups

	Description
Glatiramer Acetate 20 mg	No text entered.
Glatiramer Acetate 40 mg	No text entered.
Total	Total of all reporting groups

Baseline Measures

	Glatiramer Acetate 20 mg	Glatiramer Acetate 40 mg	Total
Number of Participants [units: participants]	586	569	1155
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	586	569	1155
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	36.3 ± 9.0	36.3 ± 9.0	36.3 ± 9.0
Gender [units: participants]
Female	421	407	828
Male	165	162	327
Region of Enrollment [units: participants]
Argentina	14	14	28
Belgium	0	1	1
Canada	15	13	28
Czech Republic	33	34	67
Estonia	11	12	23
Finland	9	7	16
France	10	11	21
Germany	50	48	98
Hungary	27	27	54
Israel	14	14	28
Italy	47	43	90
Latvia	14	14	28
Lithuania	14	14	28
Netherlands	7	6	13
Poland	36	35	71
Romania	29	28	57
Russian Federation	87	88	175
Spain	23	22	45
United Kingdom	11	10	21
United States	135	128	263

Outcome Measures

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1. Primary:

The Rate of Confirmed Relapses During the Double-blind Phase (12 Months). [ Time Frame: 12 months ]

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2. Secondary:

The Number of New T2 Lesions at Month 12 as Compared to the Baseline Scan. [ Time Frame: 12 months ]

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3. Secondary:

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 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Chen Duksin, MD
Organization: Teva Pharmaceutical Industries, Ltd.
phone: 972-9-863-4642
e-mail: chen.duksin@teva.co.il

No publications provided

Responsible Party:	Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:	NCT00337779 History of Changes
Other Study ID Numbers:	GA/9016 (FORTE)
Study First Received:	June 14, 2006
Results First Received:	January 18, 2010
Last Updated:	October 6, 2011
Health Authority:	United States: Food and Drug Administration

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