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Safety of Switching From Rituximab to Ocrelizumab in MS Patients

NCT02980042 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-07-21

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Ocrelizumab

A humanized monoclonal antibody that targets CD20 and selectively depleted CD-20 expressing B cells

DRUG

Rituximab

A chimeric monoclonal antibody against CD20.

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Timothy Vollmer, MD · University of Colorado, Denver

  • Kavita Nair, PhD · University of Colorado, Denver

  • Enrique Alvarez, MD, PhD · University of Colorado, Denver

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2019-03-06
Completion
2019-03-06
FDA Drug
Yes

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 NCT02980042 on ClinicalTrials.gov