Study Evaluating Rapid Infusion Rituximab in Patients With Autoimmune Diseases

NCT02040116 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2018-09-07

Study results available
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Summary

The purpose of this study is to evaluate the impact of rapid infusion rituximab on the incidence of infusion-related reactions in patients with Autoimmune Diseases.

Conditions

Interventions

DRUG

Rituximab Infusion

Participants will receive their first infusion of rituximab at the standard infusion rate provided in the manufacturer labeling. If they tolerate this infusion with a grade 2 of less infusion-related reaction, the next infusion will be administered as a 90 minute rapid infusion.

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • LeAnne D Kennedy, PharmD · Wake Forest University Health Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2014-08-31
Completion
2014-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT02040116 on ClinicalTrials.gov