CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 794 enrolled
Drug / intervention
Glatiramer Acetate (GTR) +2 moredrug
Likely dose
Glatiramer Acetate (GTR) 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01489254
NCT01489254Phase 3Completed
CompareCT.gov

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

Synthon BV·interventional·Posted Dec 9, 2011·Updated Dec 29, 2016

In Brief

A Phase 3 clinical trial evaluating Glatiramer Acetate (GTR), Glatiramer Acetate (Copaxone®), and 1 other intervention for Multiple Sclerosis. Completed, enrolled 794 participants across 133 sites in 19 countries.

Detailed Summary

The purpose of this study is demonstrate that efficacy and safety of Synthon's glatiramer acetate (GTR) is equivalent to Copaxone® (Teva) in patients with relapsing remitting multiple sclerosis

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis
CountriesBelarus, Bosnia and Herzegovina, Bulgaria, Croatia, Czechia, Estonia, Georgia, Germany, Italy, Mexico, Moldova, Poland, Romania, Russia, Serbia, South Africa, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 9, 2011
Enrollment StartOct 1, 2011
Primary CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 14.6 years ago

Interventions

Glatiramer Acetate (GTR)drug

Glatiramer Acetate (GTR) 20 mg daily, for 9 months (Part 1) followed by additional 15 month treatment period (Part 2)

Glatiramer Acetate (Copaxone®)drug

Glatiramer Acetate (Copaxone), 20 mg daily, for 9 months followed by additional 15 month GTR 20 mg daily treatment period (Part 2)

Placebodrug

Placebo (daily) for 9 months followed by additional 15 month GTR 20 mg daily treatment period (Part 2)