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)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03606460
• Date of registration: 23/07/2018
• Prospective Registration: Yes
• Primary sponsor: Genentech, Inc.
• Public title: 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)
• Scientific 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
• Date of first enrolment: September 14, 2018
• Target sample size: 141
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03606460
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Ocrelizumab Dose 1

Drug: Ocrelizumab Dose 2 and Dose 3

Primary Outcome(s)

Percentage of Participants With Infusion-related Reaction (IRR) Treated With 600 mg IV Ocrelizumab [Time Frame: During or within 24 hours of administration]

Secondary Outcome(s)

Percentage of Participants With IRRs [Time Frame: During or within 24 hours of administration]

Percentage of Participants With IRRs Treated With the 300 mg Shorter Dose of Ocrelizumab [Time Frame: During or within 24 hours of administration]

Secondary ID(s)

ML40638

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 29/06/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03606460