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NCT04175834 · ClinicalTrials.gov registry record · Phase 3
Comparing Risk and Severity of IRRs in Patients Premedicated With Cetirizine vs. Diphenhydramine Prior to Ocrelizumab
A Phase 3 study of Multiple Sclerosis and Infusion Reaction, sponsored by Providence Health & Services.
- Completed
- Registry status
- Phase 3
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT04175834: Completed Phase 3 study of Multiple Sclerosis and Infusion Reaction, sponsored by Providence Health & Services.
NCT04175834 is a Phase 3 study of Multiple Sclerosis and Infusion Reaction that has completed, run by Providence Health & Services. The registered enrollment target is 19 participants, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04175834, a Phase 3 study of Multiple Sclerosis and Infusion Reaction, has completed, sponsored by Providence Health & Services.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG cetrizine
- DRUG diphenhydramine
Study Locations (1)
Oregon
- Providence Neurological Specialties West - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2020-02-05 |
| Est. Completion | 2022-05-13 |
| Phase | Phase 3 |
What the finished NCT04175834 record still lists
NCT04175834 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which cetrizine is the first listed.
NCT04175834 reports a single indexed study location in Oregon.
Frequently Asked Questions
What is clinical trial NCT04175834 about?
NCT04175834 is a clinical study titled "Comparing Risk and Severity of IRRs in Patients Premedicated With Cetirizine vs. Diphenhydramine Prior to Ocrelizumab". 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).
What is the current status of trial NCT04175834?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 19 participants. The study started on 2020-02-05. Estimated completion is 2022-05-13.
What conditions does trial NCT04175834 study?
This clinical trial studies the following conditions: Multiple Sclerosis, Infusion Reaction.
What interventions are being tested in trial NCT04175834?
The interventions under investigation include: cetrizine (DRUG), diphenhydramine (DRUG).
Who is sponsoring clinical trial NCT04175834?
This trial is sponsored by Providence Health & Services, which has 69 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04175834 being conducted?
This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04175834's enrollment target sits among peer trials
19 276th of 315 higher than 38 of 315 other Multiple Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis
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A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS)
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A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis
ACTIVE NOT RECRUITING · Phase 3
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