Multiple SclerosisPhase 3NCT07472413
Alternate Pre-med in Anti-Cluster of Differentiation 20 (CD20) Pilot Project
A Phase 3 study testing Cetirizine and Diphenhydramine in people with Multiple Sclerosis, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Cetirizine and Diphenhydramine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 1 Jul 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UHealth Boca Raton
Boca Raton, Florida, 33486
Amy Barwell, RN
Jeffrey Hernandez, DNP, APRN
About this study
Official title: Cetirizine Versus Diphenhydramine as a Pre-medication: Tolerability and Safety in Patients With MS Receiving Anti-Cluster of Differentiation 20 (CD20) Infusion Therapy
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Cetirizine, Diphenhydramine
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetirizineDrug
Also called Zyrtec
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.
DiphenhydramineDrug
Also called Benadryl
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.
| Study group | Role | What they receive |
|---|---|---|
| Cetirizine Group | Experimental | Participants in this group will receive a single oral dose of cetirizine as a pre-medication administered 30-60 minutes before their scheduled standard-of-care anti-CD20 infusion therapy at each visit. Total participation duration is approximately 6 hours. Receives: Drug: Cetirizine |
| Diphenhydramine Group | Active comparator | Participants in this group will receive a single oral dose of diphenhydramine as a pre-medication administered 30-60 minutes before their scheduled standard-of-care anti-CD20 infusion therapy at each visit. Total participation duration is approximately 6 hours. Receives: Drug: Diphenhydramine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability as Measured by Sleepiness (Stanford Sleepiness Scale)
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.
Measured: Baseline (pre-infusion), immediately post-infusion for Visits 1 and 2, and at 24-hour follow-up calls.
Secondary outcomes (5)
Tolerability as measured by fatigue impact Modified Fatigue Impact Scale (MFIS)
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.
Measured: Baseline (pre-infusion), immediately post-infusion for Visits 1 and 2, and at 24-hour follow-up calls.
Tolerability as measured by fatigue severity Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F)
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.
Measured: Baseline (pre-infusion), immediately post-infusion for Visits 1 and 2, and at 24-hour follow-up calls.
Total Chair Time (minutes)
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.
Measured: Through study completion, approximately 1 year (assessed at each infusion visit)
Number of Participants Experiencing Treatment-Related Adverse Events (AEs)
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.
Measured: 1 year
Number of Participants Experiencing Treatment-Related Serious Adverse Events (SAEs)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Hernandez, University of Miami
- Investigators
- Jeffrey Hernandez, DNP, APRN, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472413
- Sponsor's protocol ID
- 20250926
- Status last verified
- Sep 2026
- First submitted
- 24 Feb 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cetirizine Versus Diphenhydramine as a Pre-medication: Tolerability and Safety in Patients With MS Receiving Anti-Cluster of Differentiation 20 (CD20) Infusion Therapy
- ClinicalTrials.gov ID
- NCT07472413
- Acronym / sponsor ID
- 20250926
- Conditions
- Multiple Sclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cetirizine Group | Experimental | Drug: CetirizineParticipants in this group will receive a single oral dose of cetirizine as a pre-medication administered 30-60 minutes before their scheduled standard-of-care anti-CD20 infusion therapy at each visit. Total participation duration is approximately 6 hours. |
| Diphenhydramine Group | Active comparator | Drug: DiphenhydramineParticipants in this group will receive a single oral dose of diphenhydramine as a pre-medication administered 30-60 minutes before their scheduled standard-of-care anti-CD20 infusion therapy at each visit. Total participation duration is approximately 6 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CetirizineAlso: ZyrtecParticipants 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. | Drug | Cetirizine Group |
| DiphenhydramineAlso: BenadrylParticipants 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. | Drug | Diphenhydramine Group |
Primary outcome
Tolerability as Measured by Sleepiness (Stanford Sleepiness Scale)
Time frame: 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.
5 secondary outcomes
Tolerability as measured by fatigue impact Modified Fatigue Impact Scale (MFIS)
Time frame: Baseline (pre-infusion), immediately post-infusion for Visits 1 and 2, and at 24-hour follow-up calls.
Tolerability as measured by fatigue severity Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F)
Time frame: Baseline (pre-infusion), immediately post-infusion for Visits 1 and 2, and at 24-hour follow-up calls.
Total Chair Time (minutes)
Time frame: Through study completion, approximately 1 year (assessed at each infusion visit)
Number of Participants Experiencing Treatment-Related Adverse Events (AEs)
Time frame: 1 year
Number of Participants Experiencing Treatment-Related Serious Adverse Events (SAEs)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeffrey Hernandez, DNP, APRN principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cetirizine and Diphenhydramine in people with Multiple Sclerosis, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey Hernandez, DNP, APRN (305-243-8873, j.hernandez261@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability as Measured by Sleepiness (Stanford Sleepiness Scale) (time frame: Baseline (pre-infusion), immediately post-infusion for Visits 1 and 2, and at 24-hour follow-up calls.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.