Comparison of Rituximab Induction Therapy Followed by Glatiramer Acetate

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT01569451
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    intravenous (IV) infusion of 1000 mg of rituximab on study days 1 (baseline visit) and 15
  • Glatiramer Acetate — DRUG
    20 mg injected subcutaneously daily
  • Placebo — OTHER
    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.

Study Details

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).

Key Dates

Start date
Feb 29, 2012
Status verified
Jun 2018
Primary completion
May 31, 2015
Completion
May 31, 2015

Study Design

Enrollment
53 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: (Placebo and) Glatiramer Acetate
    Subjects will receive an intravenous (IV) infusion of placebo (normal saline) on study days 1 (baseline visit) and 15 according to the infusion protocol. On study day 28, all subjects will initiate standard Glatiramer Acetate therapy, 20 mg injected subcutaneously daily.
  • Experimental: Rituximab and Glatiramer Acetate (R-GA)
    Subjects will receive an intravenous (IV) infusion of 1000 mg of rituximab on study days 1 (baseline visit) and 15 according to the rituximab infusion protocol. On study day 28, subjects will initiate standard Glatiramer Acetate therapy, 20 mg injected subcutaneously daily. There is no placebo arm.

Primary Outcome Measure

Number of Disease-free Patients [ Time Frame: Baseline through 24 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado HospitalAuroraColorado80045-

Find similar trials in Aurora, CO

By condition
Multiple sclerosis
By specialty
NeurologyBrain disordersAutoimmune disease
By research site
University of Colorado Hospital· Aurora, CO

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