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)

Completed · Phase 3

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID: NCT03606460
Run by: Genentech, Inc.
People needed: 141
Starts: 2018-09-14
Expected to finish: 2019-05-31
Last updated by the study team: 2020-06-29

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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

Where it is running

University of Colorado; Anschutz Medical Campus Department of Neurology — Aurora, Colorado, United States
Dragonfly Research, LLC — Wellesley, Massachusetts, United States
Cleveland Clinic Fndn — Cleveland, Ohio, United States
Ohio Health Research Institute Grant Medical Center — Columbus, Ohio, United States
Oklahoma Medical Research Foundation; MS Center of Excellence — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.