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NCT03606460 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety of Administering Ocrelizumab Per a Shorter Infusion Protocol in Participants With Primary Progressive Multiple Sclerosis (PPMS) and Relapsing Multiple Sclerosis (RMS)
A Phase 3 study of Multiple Sclerosis, sponsored by Genentech.
- Completed
- Registry status
- Phase 3
- Development phase
- 141
- Enrollment target
- 5
- Study locations
NCT03606460: Completed Phase 3 study of Multiple Sclerosis, sponsored by Genentech.
NCT03606460 is a Phase 3 study of Multiple Sclerosis that has completed, run by Genentech. The registered enrollment target is 141 participants, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (76% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03606460, a Phase 3 study of Multiple Sclerosis, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 141 participants
- Enrollment target
- 5
- Study locations
Study Summary
This study is an open-label, non-randomized study to evaluate rate and severity of infusion-related reactions (IRRs) of ocrelizumab infused over a shorter time period than the approved administration rate in participants with PPMS or RMS in the United States (U.S.). Participants will be enrolled into two cohorts. Cohort 1 will examine the effect of administering ocrelizumab per a shorter infusion protocol for Dose 2 or Dose 3. This cohort will consist of patients who have already received one or two doses of ocrelizumab according to the approved infusion protocol (i.e., per the currently U.S. label) and have reported no serious IRRs and who will then receive the next infusion of ocrelizumab at a higher rate in order to deliver 600 mg over the course of approximately 2 hours. Cohort 2 will examine the effect of administering ocrelizumab per a shorter infusion protocol for the second infusion of Dose 1. This cohort will consist of ocrelizumab naïve patients who, after receiving Infusion 1/Dose 1 of ocrelizumab at the approved rate (300 mg over approximately 2.5 hours or longer) have no reported serious IRRs, will then receive the second 300-mg shorter infusion over approximately 1.5 hours.
Primary Outcome
This outcome measure evaluates the occurrence of severe infusion-related reaction (IRR) with ocrelizumab 600 mg intravenously (IV) administered over the course of 2 hours. Rate and frequency of NCI CTCAE v4.0 Grade 3 and 4 IRRs
Conditions Studied
Interventions
- DRUG Ocrelizumab Dose 1
- DRUG Ocrelizumab Dose 2 and Dose 3
Study Locations (5)
Ohio
- Cleveland Clinic Fndn - Cleveland
- Ohio Health Research Institute Grant Medical Center - Columbus
Colorado
- University of Colorado; Anschutz Medical Campus Department of Neurology - Aurora
Massachusetts
- Dragonfly Research, LLC - Wellesley
Oklahoma
- Oklahoma Medical Research Foundation; MS Center of Excellence - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2018-09-14 |
| Est. Completion | 2019-05-31 |
| Phase | Phase 3 |
What the finished NCT03606460 record still lists
NCT03606460 is an interventional study that assigns participants to a tested intervention. The registered 141 participants enrollment target is mid-sized for trials with a published cap, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which Ocrelizumab Dose 1 is the first listed.
NCT03606460 lists 5 locations in 4 states (Ohio, Colorado, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT03606460 about?
NCT03606460 is a clinical study titled "A Study to Evaluate the Safety of Administering Ocrelizumab Per a Shorter Infusion Protocol in Participants With Primary Progressive Multiple Sclerosis (PPMS) and Relapsing Multiple Sclerosis (RMS)". This study is an open-label, non-randomized study to evaluate rate and severity of infusion-related reactions (IRRs) of ocrelizumab infused over a shorter time period than the approved administration rate in participants with PPMS or RMS in the United States (U.S.). Participants will be enrolled int...
What is the current status of trial NCT03606460?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 141 participants. The study started on 2018-09-14. Estimated completion is 2019-05-31.
What conditions does trial NCT03606460 study?
This clinical trial studies the following conditions: Multiple Sclerosis.
What interventions are being tested in trial NCT03606460?
The interventions under investigation include: Ocrelizumab Dose 1 (DRUG), Ocrelizumab Dose 2 and Dose 3 (DRUG).
Who is sponsoring clinical trial NCT03606460?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03606460 being conducted?
This trial has 5 study locations across Colorado, Massachusetts, Ohio, Oklahoma. 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 NCT03606460's enrollment target sits among peer trials
141 100th of 315 higher than 216 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
-
Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis
RECRUITING · Phase 3
-
Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis
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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 Primary Progressive Multiple Sclerosis (PPMS)
ACTIVE NOT RECRUITING · Phase 3
-
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS)
ACTIVE NOT RECRUITING · Phase 3
-
A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis
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