Phase 4
N=19
Study Evaluating Rapid Infusion Rituximab in Patients With Autoimmune Diseases
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT02040116 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Incidence of Infusion Related Reactions With Rapid Infusion Will be Reported — 0; 0 infusion reactions
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Rituximab Infusion (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Infusion Related Reactions With Rapid Infusion Will be Reported |
0; 0 | — |
| PRIMARY Grade of Infusion Related Reactions With Rapid Infusion Will be Reported |
— | — |
| SECONDARY Change in Chair Time With Rapid Infusion Will be Reported |
-10 | — |
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT02040116). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.