Multiple Sclerosis
Conditions
Brief summary
The purpose of this study is to assess and compare how well multiple sclerosis (MS) patients tolerate cetirizine versus diphenhydramine as a pre-medication before receiving anti-CD20 infusion therapy of ocrelizumab, ublituximab or rituximab. The study will also compare the safety of cetirizine versus diphenhydramine as a pre-medication for preventing infusion reactions in MS patients receiving anti-CD20 infusion therapy.
Interventions
DRUGCetirizine
Participants will receive a single oral dose of cetirizine 10 mg administered 30-60 minutes before the scheduled standard-of-care anti-CD20 infusion at each visit.
DRUGDiphenhydramine
Participants will receive a single oral dose of diphenhydramine 50 mg administered 30-60 minutes before the scheduled standard-of-care anti-CD20 infusion at each visit.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ages ≥18 years * Able to read and speak in English or Spanish * Able to and willing to give informed consent * Diagnosis of Multiple Sclerosis (MS) * Patients starting or currently receiving ocrelizumab, ublituximab, rituximab
Exclusion criteria
* Adults unable or unwilling to consent * Patients younger than 18 years of age * Pregnant women * Known hypersensitivity to cetirizine or any of its ingredients or hydroxyzine * Moderate or severe renal impairment (creatinine clearance or 11-31 mL/min or worse) * Patients with prior hypersensitivity reactions on additional preventative measures (e.g. H1 and H2/proton-pump inhibitor (PPI) the night prior to the infusion due to history of reactions)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability as Measured by Sleepiness (Stanford Sleepiness Scale) | Baseline (pre-infusion), immediately post-infusion for Visits 1 and 2, and at 24-hour follow-up calls. | Sleepiness will be assessed using the Stanford Sleepiness Scale (SSS), a validated self-administered tool that rates sleepiness on a 7-point scale. Score on a 1-7 scale. Higher scores indicate greater sleepiness, and lower scores indicate greater alertness. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability as measured by fatigue impact Modified Fatigue Impact Scale (MFIS) | Baseline (pre-infusion), immediately post-infusion for Visits 1 and 2, and at 24-hour follow-up calls. | Fatigue will be assessed using the Modified Fatigue Impact Scale (MFIS), a validated 21-item self-administered questionnaire that evaluates the impact of fatigue across physical, cognitive, and psychosocial domains. Each item is scored on a 5-point Likert scale (0-4), producing a total score range of 0-84, with higher scores indicating greater fatigue impact. |
| Tolerability as measured by fatigue severity Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F) | Baseline (pre-infusion), immediately post-infusion for Visits 1 and 2, and at 24-hour follow-up calls. | Fatigue severity will be assessed using the Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F), a validated 18-item self-administered instrument that measures the participant's current experience of fatigue and energy. Each item is scored by marking a point along a 100-mm visual analogue line anchored by "Not at all tired" (0 mm) and "Extremely tired" (100 mm). Scores are recorded as the distance in millimeters from the left anchor, producing a score range of 0-100 mm, with higher scores indicating greater fatigue severity. |
| Total Chair Time (minutes) | Through study completion, approximately 1 year (assessed at each infusion visit) | Total duration, in minutes, that the participant occupies the infusion chair during each study visit. Chair time will be measured from the participant's arrival for the infusion appointment to the time of discharge. |
| Number of Participants Experiencing Treatment-Related Adverse Events (AEs) | 1 year | Incidence of treatment-related toxicity will be reported as the number of participants experiencing treatment-related adverse events (AEs). AEs will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0, per physician discretion and will be identified through retrospective review of infusion documentation and follow-up assessments. |
| Number of Participants Experiencing Treatment-Related Serious Adverse Events (SAEs) | 1 year | Incidence of treatment-related toxicity will be reported as the number of participants experiencing treatment-related serious adverse events (SAEs). SAEs will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0, per physician discretion and will be identified through retrospective review of infusion documentation and follow-up assessments. |
Countries
United States
Contacts
CONTACTJeffrey Hernandez, DNP, APRN
PRINCIPAL_INVESTIGATORJeffrey Hernandez, DNP, APRN
University of Miami
Outcome results
None listed