Study Evaluating Rapid Infusion Rituximab in Patients With Autoimmune Diseases

NCT02040116 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB00022197
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Rapid Infusion Rituximab

Outcome Measures

Primary Outcomes (2)

• Incidence of Infusion Related Reactions With Rapid Infusion Will be Reported

  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.

  14 Days

• Grade of Infusion Related Reactions With Rapid Infusion Will be Reported

  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.

  14 Days

Secondary Outcomes (1)

• Change in Chair Time With Rapid Infusion Will be Reported

  14 Days

Study Arms (1)

rituximab infusion

OTHER

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

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.

Also known as: Rituxan

rituximab infusion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: LeAnne Kennedy
• Organization: Wake Forest Baptist Medical Center

lakenned@wakehealth.edu

336-713-3400

Study Officials

• LeAnne D Kennedy, PharmD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2014
• First Posted: January 20, 2014
• Study Start: February 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 7, 2018
• Results First Posted: September 20, 2017

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)