CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 53 enrolled
Drug / intervention
Rituximab +2 moredrug
Likely dose
Rituximab 1000 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/NCT01569451
NCT01569451Phase 2Completed
CompareCT.gov

A Double Blinded, Randomized Study Comparing Rituximab Induction Therapy Followed by Glatiramer Acetate Therapy to Glatiramer Acetate Monotherapy in Patients With Relapsing Forms of Multiple Sclerosis

University of Colorado, Denver·interventional·Posted Apr 3, 2012·Updated Jun 8, 2018

In Brief

A Phase 2 clinical trial evaluating Rituximab, Glatiramer Acetate, and 1 other intervention for Multiple Sclerosis. Completed, enrolled 53 participants across 1 site.

Detailed Summary

The purpose of this study is (1) to determine if rituximab induction therapy followed by glatiramer acetate (GA) is substantially superior to placebo rituximab induction followed by GA for the treatment of clinically isolated syndrome (CIS) or relapsing forms of multiple sclerosis (RMS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis
CountriesUnited States
CollaboratorsRocky Mountain MS Research Group, LLC

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 3, 2012
Enrollment StartFeb 1, 2012
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 14.2 years ago

Interventions

Rituximabdrug

intravenous (IV) infusion of 1000 mg of rituximab on study days 1 (baseline visit) and 15

Glatiramer Acetatedrug

20 mg injected subcutaneously daily

Placeboother

Subjects will receive an intravenous (IV) infusion of 1000 mg of rituximab or placebo (normal saline) on study days 1 (baseline visit) and 15 according to the rituximab infusion protocol. On study day 28, all subjects will initiate standard GA therapy, 20 mg injected subcutaneously daily.