MedTrace Logo

Comparison of Rituximab Induction Therapy Followed by Glatiramer Acetate

NCT01569451 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2018-06-08

Study results available
· View outcomes & findings →

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).

Conditions

Interventions

DRUG

Rituximab

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

DRUG

Glatiramer Acetate

20 mg injected subcutaneously daily

OTHER

Placebo

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.

Sponsors & Collaborators

  • Rocky Mountain MS Research Group, LLC

    collaborator OTHER

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Timothy Vollmer, MD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01569451 on ClinicalTrials.gov