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)
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|ClinicalTrials.gov Identifier: NCT03606460|
Recruitment Status : Completed
First Posted : July 30, 2018
Results First Posted : June 1, 2020
Last Update Posted : June 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: Ocrelizumab Dose 1 Drug: Ocrelizumab Dose 2 and Dose 3||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||141 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase IIIb, Open-Label Study To Evaluate The Safety And Tolerability Of Shorter Infusions Of Ocrelizumab In Patients With Primary Progressive And Relapsing Multiple Sclerosis|
|Actual Study Start Date :||September 14, 2018|
|Actual Primary Completion Date :||May 31, 2019|
|Actual Study Completion Date :||May 31, 2019|
Experimental: Cohort 1
This cohort will examine the effect of administering ocrelizumab per a shorter infusion protocol for Dose 2 or Dose 3. Participants who have already received one or two doses of ocrelizumab according to the approved infusion protocol and have reported no serious infusion-related reactions (IRRs) will be enrolled. They will then receive the next infusion of ocrelizumab (Dose 2 or Dose 3) at a dosage of 600 milligram (mg) over the course of approximately 2 hours. Dose 2 is administered at Week 24, Dose 3 is administered at Week 48 after initial infusion.
Drug: Ocrelizumab Dose 2 and Dose 3
600 mg infusion of ocrelizumab administered at a shorter rate (i.e. over the course of approximately 2 hours) at Week 24 and at Week 48
Experimental: Cohort 2
This cohort will examine the effect of administering ocrelizumab per a shorter infusion protocol for the second infusion of Dose 1. Ocrelizumab-naïve participants will be enrolled who, after receiving Dose 1 of ocrelizumab at the approved rate have no reported serious IRRs, will then receive the second 300-mg shorter infusion over approximately 1.5 hours.
Drug: Ocrelizumab Dose 1
300 mg infusion administered to ocrelizumab-naive participants per approved protocol (over approximately 2.5 hours or longer) as per standard of care followed by a second 300 mg shorter infusion over approximately 1.5 hours.
- Percentage of Participants With Infusion-related Reaction (IRR) Treated With 600 mg IV Ocrelizumab [ Time Frame: During or within 24 hours of administration ]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
- Percentage of Participants With IRRs [ Time Frame: During or within 24 hours of administration ]This outcome measure evaluates the occurrence of overall IRRs with ocrelizumab either 300mg or 600mg IV infusion. Rate and frequency of NCI CTCAE v4.0 Grade 1-4 IRRs.
- Percentage of Participants With IRRs Treated With the 300 mg Shorter Dose of Ocrelizumab [ Time Frame: During or within 24 hours of administration ]This outcome measure evaluate the occurrence of severe IRRs with ocrelizumab 300 mg administered over the course of 1.5 hours. Rate and frequency of NCI CTCAE v4.0 Grade 3-4 IRRs.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03606460
|United States, Colorado|
|University of Colorado; Anschutz Medical Campus Department of Neurology|
|Aurora, Colorado, United States, 80045|
|United States, Massachusetts|
|Dragonfly Research, LLC|
|Wellesley, Massachusetts, United States, 02481|
|United States, Ohio|
|Cleveland Clinic Fndn|
|Cleveland, Ohio, United States, 44195|
|Ohio Health Research Institute Grant Medical Center|
|Columbus, Ohio, United States, 43215|
|United States, Oklahoma|
|Oklahoma Medical Research Foundation; MS Center of Excellence|
|Oklahoma City, Oklahoma, United States, 73104|
|Study Director:||Clinical Trials||Hoffmann-La Roche|