Comparing Risk and Severity of IRRs in Patients Premedicated With Cetirizine vs. Diphenhydramine Prior to Ocrelizumab

Completed · Phase 3

Conditions studied: Multiple Sclerosis, Infusion Reaction

In brief

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).

Key facts

Study ID

NCT04175834

Run by

Providence Health & Services

People needed

19

Starts

2020-02-05

Expected to finish

2022-05-13

Last updated by the study team

2024-03-04

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Providence Neurological Specialties West — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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