Effects of Ocrevus in Relapsing Multiple Sclerosis

NCT04387734 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: RO-IIS-2019-20273
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Relapsing Multiple Sclerosis

Keywords

Mobility; Fall risk; Balance; Multiple sclerosis; T2LV

Outcome Measures

Primary Outcomes (1)

• Dynamic Gait Stability

  To quantify dynamic balance of participants during level walking.

  12 months

Secondary Outcomes (13)

• Gait speed

  12 months

• Step length

  12 months

• Step width

  12 months

• Step time

  12 months

• Cadence

  12 months

Study Arms (2)

Ocrevus

EXPERIMENTAL

Drug: Ocrelizumab

Other Disease Modifying Treatments

ACTIVE COMPARATOR

Other Disease Modifying Treatments will consist of FDA-approved injectable and oral medications for multiple sclerosis.

Drug: Platform

Interventions

Platform DRUG

The applications of the platform DMTs will follow the FDA-approved regulations.

Also known as: Other injectable Disease Modification Treatments

Other Disease Modifying Treatments

Ocrelizumab DRUG

Ocrevus will be administered following the FDA's regulations.

Also known as: Ocrevus

Ocrevus

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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;

Sponsors & Collaborators

• Multiple Sclerosis Center of Atlanta: collaborator
• Georgia State University: lead

Study Sites (2)

Georgia State University

Atlanta, Georgia, 30303, United States

Location

Multiple Sclerosis Center of Atlanta

Atlanta, Georgia, 30327, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

ocrelizumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Feng Yang, PhD

  Georgia State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 14, 2020
• Study Start: February 5, 2021
• Primary Completion: February 17, 2025
• Study Completion: February 28, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)