Study Evaluating Rapid Infusion Rituximab in Patients With Autoimmune Diseases

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT02040116
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab Infusion — DRUG
    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.

Study Details

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.

Key Dates

Start date
Feb 28, 2013
Status verified
Aug 2018
Primary completion
Aug 31, 2014
Completion
Aug 31, 2014

Study Design

Enrollment
19 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: rituximab infusion
    Every patient is getting the same therapy of rituximab. If day 1 is tolerated at standard infusion then day 14 and beyond will be given as rapid infusion over 90 minutes

Primary Outcome Measure

Incidence of Infusion Related Reactions With Rapid Infusion Will be Reported [ Time Frame: 14 Days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest Baptist Medical CenterWinston-SalemNorth Carolina27157-

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