Effects of Ocrevus in Relapsing Multiple Sclerosis

Running, not enrolling · Phase 4

Conditions studied: Relapsing Multiple Sclerosis

In brief

The purpose of this study is to test if people with relapsing multiple sclerosis (RMS) can improve ambulatory functions after one-year treatment with Ocrevus in comparison with other Disease Modifying Treatments (DMT). Sixty qualified individuals with RMS will be evenly assigned into two groups: Ocrevus and other DMT. Each group will receive the respective treatment following the FDA regulations over the one-year course. Their ambulatory functions will be assessed five times three months apart. In addition, they will receive brain MRI scans three times six months apart. Their ambulatory functions and MRI measurements will be compared between groups over time to fulfill the purposes of this study.

Key facts

Study ID

NCT04387734

Run by

Georgia State University

People needed

60

Starts

2021-02-05

Expected to finish

2026-09-30

Last updated by the study team

2026-06-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ability to provide written, informed consent and to be compliant with the schedule of protocol assessments;
• Ages 18-65 years old at screening;
• Clinically confirmed active, relapsing forms of MS (RMS) based on the revised McDonald criteria;
• Can walk at least 25 feet independently with or without assistive device at screening (or the Expanded Disability Status Scale between 1 and 6.5);
• Can stand independently for at least 30 seconds;
• Not pregnant at screening and throughout the study;
• No other neurological conditions and recent musculoskeletal injuries;
• Can read and understand English;
• No significant cognitive impairment.

You may not qualify if…

• History of other types of MS at screening such as, primary-progressive MS);
• Inability to complete an MRI (contraindications for MRI include but are not limited to claustrophobia, body mass greater than 140 kg, pacemaker, cochlear implants, presence of foreign substances in the eye, intracranial vascular clips, surgery within 6 weeks of entry into the study, coronary stent implanted within 8 weeks before the time of the intended MRI, etc);
• Patients with an active hepatitis B virus (HBV) infection;
• Have a life-threatening allergic reaction to ocrelizumab or any of its ingredients in the past;
• Hypersensitive to any of the ingredients of ocrelizumab;
• Do not understand English.
• Exclusions related to general health
• Pregnancy or lactation;
• Have any other known neurological diseases which may mimic MS including but not limited to: Neuromyelitis optica, Lyme disease, untreated vitamin B12 deficiency, neurosarcoidosis, and cerebrovascular disorders;
• Suffering from coexisting psychiatric disorders, neurological disorders, or severe medical illness;
• Current severe depression and/or suicidal ideation;
• Significant cognitive impairment (Montreal Cognitive Assessment score < 24);
• New onset, unstable orthopedic comorbid diagnoses (within 3 months and uncontrolled);
• History or currently active primary or secondary immunodeficiency;
• Receipt of a live vaccine within 6 weeks prior to baseline;
• Skin is allergic to transparent double-side tapes;
• Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study;
• History or currently active primary or secondary immunodeficiency;
• Lack of peripheral venous access;
• History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies;
• Significant or uncontrolled somatic disease or any other significant disease that may preclude patient from participating in the study;
• Congestive heart failure (NYHA III or IV functional severity);
• Known active bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds;
• Infection requiring hospitalization or treatment with i.v. antibiotics within 4 weeks prior to baseline visit or oral antibiotics within 2 weeks prior to baseline visit;
• History or known presence of recurrent or chronic infection (e.g., hepatitis B or C, HIV, syphilis, tuberculosis);

Where it is running

• Georgia State University — Atlanta, Georgia, United States
• Multiple Sclerosis Center of Atlanta — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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