CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 209 enrolled
Drug / intervention
GA 20 mg/mL +1 moredrug
Likely dose
GA 20 mg/mLfrom 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/NCT01874145
NCT01874145Phase 3Completed
CompareCT.gov

An Open-Label, Randomized, Multi-Center, Parallel-Arm Study to Assess the Safety and Tolerability of Glatiramer Acetate 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily Subcutaneous Injections in Subjects With Relapsing-Remitting Multiple Sclerosis

Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Jun 10, 2013·Updated Jan 14, 2016

In Brief

A Phase 3 clinical trial evaluating GA 20 mg/mL and GA 40 mg/mL for Relapsing-Remitting Multiple Sclerosis. Completed, enrolled 209 participants across 35 sites.

Detailed Summary

This is an open-label, randomized, multi-center, parallel-arm study to assess the safety and tolerability of a daily dose of Glatiramer Acetate (GA) 40 mg/mL three times a week (TIW) administered subcutaneously (SC) as compared to GA 20 mg/mL every day (QD) administered SC.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing-Remitting Multiple Sclerosis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 10, 2013
Enrollment StartJun 1, 2013
Primary CompletionApr 1, 2014
Study CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.1 years ago

Interventions

GA 20 mg/mLdrug

Glatiramer acetate (GA) 20 mg/mL subcutaneous (SC) injection, the commercial product, is a single-use pre-filled syringe (PFS) containing 1.0 ml of a clear, colorless to slightly yellow, sterile, non-pyrogenic solution.

GA 40 mg/mLdrug

Glatiramer acetate (GA) 40 mg/mL subcutaneous (SC) injection, is a single-use pre-filled syringe (PFS) containing 1.0 ml of a clear, colorless to slightly yellow, sterile, non-pyrogenic solution.