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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03606460
Recruitment Status : Completed
First Posted : July 30, 2018
Results First Posted : June 29, 2020
Last Update Posted : June 29, 2020
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Ocrelizumab Dose 1 Drug: Ocrelizumab Dose 2 and Dose 3 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Ocrelizumab

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible to receive ocrelizumab per the United States Package Insert (USPI)
  • Able to comply with the study protocol, in the investigator's judgment
  • Age 18-55 years, inclusive
  • Have a diagnosis of PPMS or RMS, confirmed per the revised 2017 McDonald criteria
  • Expanded Disability Status Scale (EDSS) score of 0 to 6.5, inclusive
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 6 months after the last dose of study treatment (per the USPI)

Exclusion Criteria:

  • Experienced serious IRR(s)
  • History of life-threatening infusion reaction to ocrelizumab
  • Known presence of other neurological disorders
  • Pregnancy or lactation, or intention to become pregnant during the study
  • Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
  • Significant, uncontrolled disease, such as cardiovascular (including cardiac arrhythmia), pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine, and gastrointestinal or any other significant disease that may preclude patient from participating in the study
  • Congestive heart failure
  • Known active bacterial, viral, fungal, mycobacterial infection or other infection or any severe episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks prior to baseline visit or oral antibiotics within 2 weeks prior to baseline visit
  • History of or currently active primary or secondary immunodeficiency
  • History or known presence of recurrent or chronic infection (e.g., HIV, syphilis, tuberculosis)
  • History of recurrent aspiration pneumonia requiring antibiotic therapy
  • History of malignancy, including solid tumors and hematological malignancies,except basal cell, in situ squamous cell carcinoma of the skin, and in situ carcinoma of the cervix of the uterus that have been excised with clear margins
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
  • History of alcohol or drug abuse within 24 weeks prior to enrollment
  • Receipt of a live vaccine within 6 weeks prior to enrollment
  • Systemic corticosteroid therapy within 4 weeks prior to enrollment
  • Contraindications to or intolerance of oral or IV corticosteroids, including IV methylprednisolone (or equivalent steroid) administered according to the country label
  • Treatment with alemtuzumab
  • Treatment with a B-cell targeted therapies other than ocrelizumab
  • Treatment with a drug that is experimental
  • Abnormal laboratory results per local laboratory standards and investigator assessment

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
  Study Documents (Full-Text)

Documents provided by Genentech, Inc.:
Study Protocol  [PDF] June 6, 2018
Statistical Analysis Plan  [PDF] June 26, 2019

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT03606460    
Other Study ID Numbers: ML40638
First Posted: July 30, 2018    Key Record Dates
Results First Posted: June 29, 2020
Last Update Posted: June 29, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Ocrelizumab
Immunologic Factors
Physiological Effects of Drugs