Comparing Risk and Severity of IRRs in Patients Premedicated With Ceti
Comparing the Risk and Severity of Infusion-Related Reactions in Patients Premedicated With Cetirizine Versus Diphenhydramine Prior to Ocrelizumab Infusions
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- cetrizine
- Diphenhydramine
Results by group
Proportion of Participants With Infusion-related Reaction (IRR) on Day 0
During or after the first-half dose of the first infusion on day 0
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Diphenhydramine | 5 participnats | 9 | |
| Cetirizine | 6 participnats | 10 |
Diphenhydramine
Cetirizine
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Diphenhydramine | 9 | 0 (0.0%) | 0 |
| Cetirizine | 10 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Proportion of Participants With Infusion-related Reaction (IRR) on Day 0
During or after the first-half dose of the first infusion on day 0
Safety
Other measures (7)
Proportion of Participants With Infusion-related Reaction (IRR) on Day 14
during or after receiving the second half dose infusion on day 14.
SafetyProportion of Participants With an Infusion-related Reaction (IRR) on Day 168
during or after receiving the first full 600mg dose infusion on day 168.
SafetyTreatment Satisfaction Questionnaire for Medication (TSQM) Score on Days 0, 14 and 168
After the infusions on day 0, day 14, and day 168.
Quality of life (reported by participants)SafetyStanford Sleepiness Scale (SSS) Score on Days 0, 14, and 168
after the infusions on day 0, day 14, and day 168.
Mood and sleepQuality of life (reported by participants)Visual Analog Scale for Fatigue (VAS-F) Score on Days 0, 14 and 168
after the infusions on day 0, day 14, and day 168.
FatigueQuality of life (reported by participants)Modified Fatigue Impact Scale (MFIS) Score on Day 168
at day 168.
Thinking and memoryFatigueMultiple Sclerosis Impact Scale (MSIS-29) Score on Day168
at day 168.
Quality of life (reported by participants)
Who could take part
Progressive MS · 18 to 70
Show the full criteria
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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).
Papers
Results
Hauser SL, Bar-Or A, Comi G, Giovannoni G, Hartung HP, Hemmer B, Lublin F, Montalban X, Rammohan KW, Selmaj K, Traboulsee A, Wolinsky JS, Arnold DL, Klingelschmitt G, Masterman D, Fontoura P, Belachew S, Chin P, Mairon N, Garren H, Kappos L; OPERA I and OPERA II Clinical Investigators. Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):221-234.Results
Montalban X, Hauser SL, Kappos L, Arnold DL, Bar-Or A, Comi G, de Seze J, Giovannoni G, Hartung HP, Hemmer B, Lublin F, Rammohan KW, Selmaj K, Traboulsee A, Sauter A, Masterman D, Fontoura P, Belachew S, Garren H, Mairon N, Chin P, Wolinsky JS; ORATORIO Clinical Investigators. Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):209-220. doi: 10.10
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History
Started
Feb 2020
Main results due
May 2022
Finished
May 2022
Results posted
Mar 2024