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

Providence Health & Services19 enrolled

Overview

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).

Ocrelizumab was approved by the US Food and Drug administration in March 2017 for the indication of Relapsing Remitting Multiple Sclerosis (RRMS) and Primary Progressive Multiple Sclerosis (PPMS). The landmark studies used to gain approval found ocrelizumab (OCR) to be well tolerated, but that at least one Infusion-Related Reaction (IRR) occurred in about one-third of patients. Because of this, neurologists typically prescribe prophylactic premedication with 100mg of methylprednisolone, 1 gram of acetaminophen, and 50 mg of IV diphenhydramine. However, many patients experience extreme sedation that interferes with their lifestyle considerably. 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 IRRs. Fifty-two patients, 26 patients per arm, will be randomized in a 1:1 ratio to receive cetirizine or diphenhydramine as premedication prior to OCR infusions on day 0 (1st half dose of 300mg), day 14 (2nd half dose of 300mg) and week 24 (1st full dose of 600mg).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Multiple Sclerosis Infusion Reaction

Interventions

cetrizineDRUG

prophylaxis

diphenhydramineDRUG

prophylaxis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female patient with relapsing or progressive forms of Multiple Sclerosis (MS), age 18 to 70 inclusive at the time of consent. 2. Able to understand the purpose, responsibilities and risks of the study and provide signed informed consent. 3. Naïve to ocrelizumab (OCR) and will receive OCR as part of standard of care for MS treatment. 4. No evidence, in the opinion of the investigators of significant cognitive limitation or psychiatric disorder that would interfere with the conduct of the study. 5. Estimated Expanded Disability Status Scale (EDSS) of ≤ 6.5 at screening. 6. Female patients of childbearing potential must practice effective contraception and continue contraception during the study. Exclusion Criteria: 1. Any mental condition of such that patient is unable to understand the nature, scope, and possible consequences of the study. 2. Evidence of active hepatitis B infection at screening. 3. 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. 4. Any persistent or severe infection. 5. Pregnancy or lactation. 6. Significant, uncontrolled somatic disease or severe depression in the last year. 7. Current use of immunosuppressive medication, lymphocyte-depleting agents, or lymphocyte-trafficking blockers. 8. Patients with any significant comorbidity that in the opinion of the investigator, would interfere with participation in the study. 9. Any known allergy or inability to tolerate diphenhydramine or cetirizine.

Locations (1)

Providence Neurological Specialties West

Portland, Oregon, United States

Outcomes

Primary Outcomes

Proportion of Participants With Infusion-related Reaction (IRR) on Day 0

The proportion of patients having an infusion-related reaction (IRR), as defined by Common Terminology Criteria (CTCAE), version 4 during or after the first-half dose of the first infusion on day 0. IRRs are documented at the infusion clinic on the day of infusion and reported by the patient at the follow-up phone call the next business day after the infusion.

Time frame: During or after the first-half dose of the first infusion on day 0

Secondary Outcomes

Proportion of Participants With Infusion-related Reaction (IRR) on Day 14

The proportion of patients having an infusion-related reaction as defined by Common Terminology Criteria (CTCAE), version 4 during or after receiving the second half dose infusion on day 14

Time frame: during or after receiving the second half dose infusion on day 14.

Proportion of Participants With an Infusion-related Reaction (IRR) on Day 168

The proportion of patients having an infusion-related reaction as defined by Common Terminology Criteria (CTCAE), version 4 during or after receiving the first full 600mg dose infusion on week 168

Time frame: during or after receiving the first full 600mg dose infusion on day 168.

Treatment Satisfaction Questionnaire for Medication (TSQM) Score on Days 0, 14 and 168

Patient reported outcome on Treatment Satisfaction Questionnaire for Medication. TSQM is administered within 2 hours after ocrelizumab (OCR) infusion, may be completed via phone to assess patient treatment satisfaction for the infusion. TSQM covers four domains: Global satisfaction, Effectiveness, Side effects, and Convenience. The scores are calculated for each of the subscales, ranging from 0 to 100. Higher score indicates higher satisfaction of the participant with the treatment and lower score indicates lower satisfaction of the participant with the treatment.

Time frame: After the infusions on day 0, day 14, and day 168.

Data from ClinicalTrials.gov

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