Phase 3
Completed N=19
Comparing Risk and Severity of IRRs in Patients Premedicated With Cetirizine vs. Diphenhydramine Prior to Ocrelizumab
Multiple Sclerosis · Infusion Reaction
Source: ClinicalTrials.gov NCT04175834 ↗
Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcomePrimary: Proportion of Participants With Infusion-related Reaction (IRR) on Day 0 — 5; 6 participnats
◆ Published Evidence
Highly cited
1,972citations · ~219 / year
Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis.
Summary
This 6-month randomized controlled pilot study will determine whether there is some evidence that cetirizine is better tolerated than diphenhydramine without an increase in Infusion-Related Reactions (IRRs) in subjects receiving ocrelizumab(OCR) for multiple sclerosis (MS).
Linked Publications (2)
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Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis.
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Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With Infusion-related Reaction (IRR) on Day 0 |
5; 6 | — |
| SECONDARY Proportion of Participants With Infusion-related Reaction (IRR) on Day 14 |
6; 8 | — |
| SECONDARY Proportion of Participants With an Infusion-related Reaction (IRR) on Day 168 |
7; 8 | — |
| SECONDARY Treatment Satisfaction Questionnaire for Medication (TSQM) Score on Days 0, 14 and 168 |
88.0; 90.8; 78.7; 86.7; 94.4; 100 | — |
| SECONDARY Stanford Sleepiness Scale (SSS) Score on Days 0, 14, and 168 |
3.11; 1.90; 3.13; 2.00; 2.50; 2.33 | — |
| SECONDARY Visual Analog Scale for Fatigue (VAS-F) Score on Days 0, 14 and 168 |
4.10; 1.92; 5.20; 6.28; 3.95; 1.94 | — |
| SECONDARY Modified Fatigue Impact Scale (MFIS) Score on Day 168 |
23.9; 18.3 | — |
| SECONDARY Multiple Sclerosis Impact Scale (MSIS-29) Score on Day168 |
19.7; 6.38; 13.0; 12.3 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female patient with relapsing or progressive forms of Multiple Sclerosis (MS), age 18 to 70 inclusive at the time of consent.
- Able to understand the purpose, responsibilities and risks of the study and provide signed informed consent.
- Naïve to ocrelizumab (OCR) and will receive OCR as part of standard of care for MS treatment.
- No evidence, in the opinion of the investigators of significant cognitive limitation or psychiatric disorder that would interfere with the conduct of the study.
- Estimated Expanded Disability Status Scale (EDSS) of ≤ 6.5 at screening.
- Female patients of childbearing potential must practice effective contraception and continue contraception during the study.
Exclusion Criteria
- Any mental condition of such that patient is unable to understand the nature, scope, and possible consequences of the study.
- Evidence of active hepatitis B infection at screening.
- Patients with untreated hepatitis C, or tuberculosis. Patients who have history of Progressive multifocal leukoencephalopathy (PML) or known to be Human Immunodeficiency Virus (HIV) positive, per standard care.
- Any persistent or severe infection.
- Pregnancy or lactation.
- Significant, uncontrolled somatic disease or severe depression in the last year.
- Current use of immunosuppressive medication, lymphocyte-depleting agents, or lymphocyte-trafficking blockers.
- Patients with any significant comorbidity that in the opinion of the investigator, would interfere with participation in the study.
- Any known allergy or inability to tolerate diphenhydramine or cetirizine.
Data sourced from ClinicalTrials.gov (NCT04175834) and the linked publication. 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. Informational only — not medical advice.