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Study Evaluating Rapid Infusion Rituximab in Patients With Autoimmune Diseases

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ClinicalTrials.gov Identifier: NCT02040116
Recruitment Status : Completed
First Posted : January 20, 2014
Results First Posted : September 20, 2017
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Rituximab Infusion Phase 4

Detailed Description:

Background Rituximab is a human/murine monoclonal antibody targeted at the CD20 antigen (cluster of differentiation antigen 20) on B-lymphocytes. The CD20 antigen is expressed in over 90% of B-cell non-Hodgkin's lymphomas. B cells are also believed to play a role in the pathogenesis of other oncologic and non-oncologic disorders. Targeting B cells appears to have a role in decreasing autoimmune and inflammatory processes, as well as antibody production in many autoimmune diseases. Rituximab is approved for the treatment of non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA) in combination with methotrexate, wegener's granulomatosis, and microscopic polyangiitis in combination with glucocorticoids. Although rituximab is not approved for multiple sclerosis, myasthenia gravis, or other autoimmune diseases, it is commonly used later in the treatment course for patients that are not responding to other treatment options. Rituximab's main limitation is the occurrence of infusion-related reactions (IRR). These reactions can include fever, chills, rash, respiratory compromise, and a variety of other symptoms, including death. The incidence of IRR is known to vary depending on the rituximab indication. The incidence of IRR with the first infusion of rituximab is approximately 77% with NHL, 27% with RA, and 12% with wegener's granulomatosis and microscopic polyangiitis. The incidence of IRR decreases with subsequent infusions of rituximab to approximately 5-10%. 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. The incidence of IRR is a chief concern for patients, nurses, and other healthcare providers.

The package labeling recommends the administration of a standard infusion of rituximab for all patients initiating rituximab therapy to minimize IRR. If this infusion is tolerated then subsequent infusions may be titrated up to a faster rate to decrease infusion time. Based on the manufacturer's package insert, rituximab is infused at a rate of 50 mg/hr and can be increased every 30 minutes by 50 mg/hr (maximum rate of 400 mg/hr). If a grade 3 or 4 IRR does not occur, subsequent infusions are given at a rate of 100 mg/hr and can be increased every 30 minutes by 100 mg/hr (maximum rate of 400 mg/hr). The average infusion time is estimated to be 4-6 hours for the first infusion, and 3-4 hours for subsequent infusions. Rituximab is typically given in cycles and the timing will vary depending on the indication.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study Evaluating Rapid Infusion Rituximab in Patients With Autoimmune Diseases
Study Start Date : February 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab

Arm Intervention/treatment
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
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.
Other Name: Rituxan




Primary Outcome Measures :
  1. Incidence of Infusion Related Reactions With Rapid Infusion Will be Reported [ Time Frame: 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.

  2. Grade of Infusion Related Reactions With Rapid Infusion Will be Reported [ Time Frame: 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 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.


Secondary Outcome Measures :
  1. Change in Chair Time With Rapid Infusion Will be Reported [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Autoimmune patient at Wake Forest Baptist Health that is eligible for rituximab therapy
  • Tolerate the standard infusion rituximab with ≤ grade 2 hypersensitivity reaction
  • Consent to participate in the rapid infusion study
  • Age ≥ 18 years ≤ 80 years

Exclusion Criteria:

  • Tolerate the standard infusion rituximab with ≥ grade 3 hypersensitivity reaction
  • Neurocognitive impairment (i.e. dementia, Alzheimers, et al)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02040116


Locations
United States, North Carolina
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Principal Investigator: LeAnne D Kennedy, PharmD Wake Forest University Health Sciences

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02040116     History of Changes
Other Study ID Numbers: IRB00022197
First Posted: January 20, 2014    Key Record Dates
Results First Posted: September 20, 2017
Last Update Posted: September 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
Rapid Infusion Rituximab

Additional relevant MeSH terms:
Multiple Sclerosis
Autoimmune Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Immune System Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents