Efficacy and Safety of GTR in Comparison to Copaxone® (GATE)
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|ClinicalTrials.gov Identifier: NCT01489254|
Recruitment Status : Completed
First Posted : December 9, 2011
Results First Posted : October 31, 2016
Last Update Posted : December 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: Glatiramer Acetate (GTR) Drug: Glatiramer Acetate (Copaxone®) Drug: Placebo||Phase 3|
GTR is being developed by Synthon as a similar version of Copaxone®. GTR has a similar quantitative and qualitative composition as Copaxone®, with regard to active substance and excipients and is presented in the same dosage form (pre-filled syringe containing a solution for injection). Introduction of GTR is anticipated to have a price lowering effect and will give doctors and patients more choice in the pharmaceutical armamentarium for MS.
This trial consists of two parts:
Part 1 is a multi-country, multi-centre, randomized, double-blind, active and placebo-controlled, equivalence trial comparing the efficacy and safety and tolerability of GTR versus Copaxone® in subjects with RRMS. Eligible subjects will be randomly assigned to receive daily 20 mg GTR (Synthon BV), 20 mg Copaxone® (TEVA) or placebo for a period of 9 months.
In Part 2, the trial continues as an open-label uncontrolled trial to evaluate efficacy and safety of long-term treatment with GTR. Subjects completing the 9-month double-blind period will be treated with open-label 20 mg daily GTR for another 15 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||794 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, 9 Month, Equivalence Trial Comparing the Efficacy and Safety and Tolerability of GTR (Synthon BV) to Copaxone® (Teva) in Subjects With Relapsing Remitting Multiple Sclerosis Followed by an Open-label 15 Month GTR Treatment Part Evaluating the Long-term GTR Treatment Effects|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
Drug: Glatiramer Acetate (GTR)
Glatiramer Acetate (GTR) 20 mg daily, for 9 months (Part 1) followed by additional 15 month treatment period (Part 2)
Active Comparator: Copaxone®
Drug: Glatiramer Acetate (Copaxone®)
Glatiramer Acetate (Copaxone), 20 mg daily, for 9 months followed by additional 15 month GTR 20 mg daily treatment period (Part 2)
Placebo Comparator: Placebo
Placebo (daily) for 9 months followed by additional 15 month GTR 20 mg daily treatment period (Part 2)
- The Number of T1-Gadolinium Enhancing Lesions During Months 7-9 [ Time Frame: 9 months ]The primary endpoint was the total number of gadolinium enhancing lesions (i.e., the cumulative number of new and persisting gadolinium enhancing lesions) during months 7 through 9.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01489254