Safety of Switching From Rituximab to Ocrelizumab in MS Patients

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT02980042
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Ocrelizumab — DRUG
    A humanized monoclonal antibody that targets CD20 and selectively depleted CD-20 expressing B cells
  • Rituximab — DRUG
    A chimeric monoclonal antibody against CD20.

Study Details

This is a prospective between and within group observational study to determine differences in tolerability, immunogenicity and safety related outcomes for 100 multiple sclerosis (MS) patients who have been administered at least two infusions of rituximab, six months apart and are willing to be switched to ocrelizumab compared to a 100 patients who are continuing on rituximab as a comparison cohort from the clinic population treated as part of clinical care.

Key Dates

Start date
Jan 1, 2017
Status verified
Jul 2021
Primary completion
Mar 6, 2019
Completion
Mar 6, 2019

Study Design

Enrollment
200 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Switching Group
    600 mg of ocrelizumab will be administered as one 600-mg IV infusions at a scheduled interval of every 24 weeks. The first dose of ocrelizumab will be a split dose of 300 mg on day 1 and day 15 followed by 600 mg, six months later. Each ocrelizumab infusion should be given as a slow IV infusion over approximately 150 minutes (2.5 hours) for the 300-mg dose. Ocrelizumab must not be administered as an IV push or bolus. Well-adjusted infusion pumps should be used to control the infusion rate, and ocrelizumab should be infused through a dedicated line.
  • Active Comparator: Comparator Group
    Standard of care rituximab doses are 1000 mg infusion given as first dose followed by 500mg (or 1000 mg if evidence of early B cell recovery) infusion every 6 months thereafter. Rituximab must not be administered as an IV push or bolus. Well-adjusted infusion pumps should be used to control the infusion rate, and rituximab should be infused through a dedicated line

Primary Outcome Measure

Proportion of Infusions With >= 1 IRR Between the Switching and Comparator Groups [ Time Frame: Day 1, Day 15, Week 24 ]

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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