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Efficacy and Safety of GTR in Comparison to Copaxone® (GATE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Synthon BV
ClinicalTrials.gov Identifier:
NCT01489254
First received: December 8, 2011
Last updated: September 13, 2016
Last verified: September 2016
Results First Received: April 18, 2016  
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: Multiple Sclerosis
Interventions: Drug: Glatiramer Acetate (GTR)
Drug: Glatiramer Acetate (Copaxone®)
Drug: Placebo

  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
Subjects were randomized at 118 investigational sites in 17 countries.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1549 patients were assessed for eligibility of whom 796 subjects were randomized in a 4.3:4.3:1 ratio to receive generic glatiramer acetate (GTR), brand glatiramer acetate (Copaxone) or matching placebo. Two subjects were randomized to the generic glatiramer acetate group but did not start treatment and were not enrolled.

Reporting Groups
  Description
Glatiramer 20 mg Glatiramer Acetate (GTR) 20 mg daily for 9 months
Copaxone 20 mg Glatiramer Acetate (Copaxone) 20 mg daily for 9 months
Placebo Placebo (daily) for 9 months
Extension Glatiramer 20 mg Glatiramer acetate (GTR) 20 mg daily for 15 months, open-label extension

Participant Flow for 2 periods

Period 1:   Double-blind Part
    Glatiramer 20 mg   Copaxone 20 mg   Placebo   Extension Glatiramer 20 mg
STARTED   355   357   84   0 
COMPLETED   330   324   81   0 
NOT COMPLETED   25   33   3   0 
Adverse Event                7                2                2                0 
Pregnancy                1                3                0                0 
Withdrawal by Subject                12                20                1                0 
Lost to Follow-up                1                2                0                0 
Other reasons for not completing study                4                6                0                0 

Period 2:   Open-label Extension Part
    Glatiramer 20 mg   Copaxone 20 mg   Placebo   Extension Glatiramer 20 mg
STARTED   0   0   0   728 [1] 
COMPLETED   0   0   0   670 
NOT COMPLETED   0   0   0   58 
Adverse Event                0                0                0                10 
Pregnancy                0                0                0                3 
Withdrawal by Subject                0                0                0                30 
Protocol Violation                0                0                0                1 
Lost to Follow-up                0                0                0                9 
Other reasons for not completing study                0                0                0                5 
[1] 735 completed the DB part, 729 were eligible to continue in the OL part, 1 opted not to continue



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Glatiramer 20 mg Glatiramer Acetate (GTR) 20 mg daily for 9 months
Copaxone 20 mg Glatiramer Acetate (Copaxone) 20 mg daily for 9 months
Placebo Placebo (daily) for 9 months
Total Total of all reporting groups

Baseline Measures
   Glatiramer 20 mg   Copaxone 20 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 353   357   84   794 
Age 
[Units: Years]
Mean (Standard Deviation)
 32.6  (8.6)   33.8  (9.0)   32.6  (8.7)   33.1  (8.8) 
Gender 
[Units: Participants]
       
Female   233   238   57   528 
Male   120   119   27   266 
Time from first clinical event to randomization 
[Units: Years]
Mean (Standard Deviation)
 5.5  (5.3)   6.4  (6.0)   5.7  (6.0)   5.9  (5.7) 
Number of relapses in period within 2 year prior to signing ICF 
[Units: Number of relapses]
Mean (Standard Deviation)
 1.9  (0.9)   1.8  (0.9)   1.9  (0.9)   1.8  (0.9) 


  Outcome Measures

1.  Primary:   The Number of T1-Gadolinium Enhancing Lesions During Months 7-9   [ Time Frame: 9 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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.


  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:
unchecked 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.
unchecked 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.


Results Point of Contact:  
Name/Title: VP Clinical Development
Organization: Synthon BV
phone: +3124727700
e-mail: clinicaltrials@synthon.com


Publications of Results:

Responsible Party: Synthon BV
ClinicalTrials.gov Identifier: NCT01489254     History of Changes
Other Study ID Numbers: GTR001
2011-000888-27 ( EudraCT Number )
Study First Received: December 8, 2011
Results First Received: April 18, 2016
Last Updated: September 13, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
Belarus: Ministry of Health of the Republic of Belarus
Belarus: Local Ethics Committees
Bosnia and Herzegovina: Medicines and Medical Devices Agency
Bosnia and Herzegovina: Ethics Committees at Medical sites
Bulgaria: Bulgarian Drug Agency
Bulgaria: Ethics Committee for Multicenter Clinical Trials
Croatia: Ministry of Health
Croatia: Central Ethics Committee
Czech Republic: State Institute for Drug Control (SUKL)
Czech Republic: Multicenter Ethics Committee
Estonia: State Agency of Medicines
Estonia: Central Ethics Committee
Georgia: Ministry of Labour, Health and Social Affairs
Georgia: Ethics Committees at Medical sites
Germany: Federal Agency for Medicinal Products and Medical Devices (BfArM)
Germany: Regional Independent Ethics Committee
Italy: Regulatory Authority at Medical Site
Italy: Ethics Committee at Medical site
Mexico: Federal Commission for Protection against Sanitary Risks
Mexico: Ethics Committees at Medical sites
Moldova: Medicine Agency
Moldova: National Ethics Committee
Poland: Central Register of clinical trials
Poland: Multicenter Ethics Committee
Romania: National Medicine and Medical Devices Agency
Romania: National Ethics Committee
Russia: Ministry of Healthcare and Social Development of the Russian Federation
Serbia: Medicines and Medical Devices Agency
Serbia: Ethics Committees at Medical Sites
South Africa: Medicines Control Council (MCC)
South Africa: Ethics Committees at Medical sites
UK: The Medicines and Healthcare products Regulatory Agency
UK: Regional Independent Ethics Committee
Ukraine: State Expert Centre under the Ministry of Health of Ukraine
Ukraine: Central Ethics Committee