AzTrials
AzTrials

Multiple SclerosisPhase 3NCT03606460

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 testing Ocrelizumab Dose 1 and Ocrelizumab Dose 2 and Dose 3 in people with Multiple Sclerosis, run by Genentech, Inc. at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Ocrelizumab Dose 1 and Ocrelizumab Dose 2 and Dose 3
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
141 participants
Where
5 sitesUnited States
Study dates
14 Sep 2018to 31 May 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 21Show fewer
  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • University of Colorado; Anschutz Medical Campus Department of Neurology

    Aurora, Colorado, 80045

  • Cleveland Clinic Fndn

    Cleveland, Ohio, 44195

  • Ohio Health Research Institute Grant Medical Center

    Columbus, Ohio, 43215

  • Oklahoma Medical Research Foundation; MS Center of Excellence

    Oklahoma City, Oklahoma, 73104

  • Dragonfly Research, LLC

    Wellesley, Massachusetts, 02481

Other trials in United States

About this study

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

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.

Being tested
Ocrelizumab Dose 1, Ocrelizumab Dose 2 and Dose 3
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ocrelizumab Dose 1Drug

    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.

  • Ocrelizumab Dose 2 and Dose 3Drug

    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

Study groups in NCT03606460
Study groupRoleWhat they receive
Cohort 1ExperimentalThis 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.
Receives: Drug: Ocrelizumab Dose 2 and Dose 3
Cohort 2ExperimentalThis 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.
Receives: Drug: Ocrelizumab Dose 1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Infusion-related Reaction (IRR) Treated With 600 mg IV Ocrelizumab

    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

    Measured: During or within 24 hours of administration

Secondary outcomes (2)

  1. Percentage of Participants With IRRs

    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.

    Measured: During or within 24 hours of administration

  2. Percentage of Participants With IRRs Treated With the 300 mg Shorter Dose of Ocrelizumab

    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.

    Measured: During or within 24 hours of administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2018
  2. Study start14 Sep 2018
  3. Primary completion31 May 2019
  4. Study completion31 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
141 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03606460
Sponsor's protocol ID
ML40638
Status last verified
Jun 2020
First submitted
23 Jul 2018
Last updated
29 Jun 2020
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Vollmer TL, Cohen JA, Alvarez E, Nair KV, Boster A, Katz J, Pardo G, Pei J, Raut P, Merchant S, MacLean E, Pradhan A, Moss B. Safety results of administering ocrelizumab per a shorter infusion protocol in patients with primary progressive and relapsing multiple sclerosis. Mult Scler Relat Disord. 2020 Nov;46:102454. doi: 10.1016/j.msard.2020.102454. Epub 2020 Aug 18.

    PubMed 33045496

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ocrelizumab Dose 1 and Ocrelizumab Dose 2 and Dose 3 in people with Multiple Sclerosis, run by Genentech, Inc. at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Infusion-related Reaction (IRR) Treated With 600 mg IV Ocrelizumab (time frame: During or within 24 hours of administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03606460, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in