Trial Outcomes & Findings for Study Evaluating Rapid Infusion Rituximab in Patients With Autoimmune Diseases (NCT NCT02040116)

Results Overview

Patients are given therapy on day 1 and if infusion is tolerated with \< grade 2 reaction based on the CTCAE v4 then then will proceed to rapid infusion on day 14 which is given over 90 minutes. The number of infusion reaction is measured for all patients and in all infusions given.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

19 participants

Primary outcome timeframe

14 Days

Results posted on

2018-09-07

Participant Flow

Participant milestones

Participant milestones
Measure	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 Rapid Infusion Rituximab: 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.
Overall Study STARTED	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study Evaluating Rapid Infusion Rituximab in Patients With Autoimmune Diseases

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rituximab Infusion n=19 Participants 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 20 hours Rapid Infusion Rituximab: 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	40 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants

PRIMARY outcome

Timeframe: 14 Days

Patients are given therapy on day 1 and if infusion is tolerated with \< grade 2 reaction based on the CTCAE v4 then then will proceed to rapid infusion on day 14 which is given over 90 minutes. The number of infusion reaction is measured for all patients and in all infusions given.

Outcome measures

Outcome measures
Measure	Number of Reactions for Standard Infusion n=19 Participants day 1 infusion of standard infusion will be given the same to all patients and then assessed	Number of Reactions for Rapid Infusion n=19 Participants day 1 infusion of rapid infusion will be given the same to all patients and then assessed
Incidence of Infusion Related Reactions With Rapid Infusion Will be Reported	0 infusion reactions	0 infusion reactions

PRIMARY outcome

Timeframe: 14 Days

Population: Due to their being no reactions, the Grade of reactions for Standard infusion will and can not be reported, as the lowest grade requires there to be a reaction.

Patients are given therapy on day 1 and if infusion is tolerated with \< grade 2 reaction based on the CTCAE v4 then then will proceed to rapid infusion on day 14 which is given over 90 minutes. The grade of infusion reaction is measured for all patients and in all infusions given. According to the National Cancer Institute, there are 5 grades of IRR. In general, grade 1 reactions are classified as asymptomatic or only mild symptoms that do not require intervention. Grade 2 reactions are classified as moderate with minimal, local, or noninvasive interventions required. Grade 3 reactions are classified as severe and medically significant, but not immediately life-threatening. These reactions require hospitalization or prolongation of a current hospitalization. Grade 4 reactions are classified as life-threatening with urgent interventions required. Grade 5 reactions are classified as death related to an adverse drug event.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 Days

The amount of time spent administering the rituximab will be compared to the time from the first infusion to the second infusion. The change was calculated from two time points as the value at the later time point minus the value at the earlier time point.

Outcome measures

Outcome measures
Measure	Number of Reactions for Standard Infusion n=19 Participants day 1 infusion of standard infusion will be given the same to all patients and then assessed	Number of Reactions for Rapid Infusion day 1 infusion of rapid infusion will be given the same to all patients and then assessed
Change in Chair Time With Rapid Infusion Will be Reported	-10 Hours Interval -21.0 to -1.0	—

Adverse Events

Rituximab Infusion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

LeAnne Kennedy

Wake Forest Baptist Medical Center

Phone: 336-713-3400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place