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Relapsing Multiple SclerosisPhase 4MOBILE-RMSNCT04387734

Effects of Ocrevus in Relapsing Multiple Sclerosis

A Phase 4 study testing Ocrelizumab and Platform in people with Relapsing Multiple Sclerosis, run by Georgia State University at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Relapsing Multiple Sclerosis
What is being tested?
Ocrelizumab and Platform
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesUnited States
Study dates
5 Feb 2021to 30 Sep 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • No other neurological conditions and recent musculoskeletal injuries;
  • Can read and understand English;
  • No significant cognitive impairment.

Who cannot join

  • 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.
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  • 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);
  • History of progressive multifocal leukoencephalopathy (PML);
  • History of malignancy, including solid tumors and hematological malignancies, except basal cell carcinoma, in situ squamous cell carcinoma of the skin, and in situ carcinoma of the cervix of the uterus that have been previously completely excised with documented, clear margins;
  • History of alcohol or drug abuse within 24 weeks prior to baseline;
  • History or laboratory evidence of coagulation disorders;
  • Exclusions related to medications
  • Receipt of a live vaccine within 6 weeks prior to baseline;
  • Treatment with any investigational agent within 24 weeks of screening (Visit 1) or five half-lives of the investigational drug (whichever is longer);
  • Contraindications to or intolerance of oral or intravenous corticosteroids, including methylprednisolone administered intravenous, according to the country label, including:
  • Psychosis not yet controlled by a treatment;
  • Hypersensitivity to any of the constituents;
  • Treatment with dalfamipridine (Ampyra®) unless on stable dose for ≥ 30 days prior to screening. Patients should remain on stable doses throughout the 52-week treatment period;
  • Previous treatment with B-cell targeted therapies (i.e. rituximab, ocrelizumab, atacicept, belimumab or ofatumumab);
  • Systemic corticosteroid therapy within 4 weeks prior to screening;
  • Any previous treatment with alemtuzumab (Campath), anti-CD4, cladribine, mitoxantrone, daclizumab, BG12, teriflunomide, laquinimod, total body irradiation or bone marrow transplantation;
  • Treatment with cyclophosphamide, azathioprine, mycophenolate mofetil (MMF), cyclosporine, methotrexate, or natalizumab within 24 months prior to screening;
  • Treatment with intravenous immunoglobulin within 12 weeks prior to baseline.
  • Exclusions related to motor function
  • Cannot walk at least 25 feet and stand at least 30 seconds independently;
  • Weak or blind vision may impair their ability of walking;
  • Exclusions related to musculoskeletal, cardiovascular, and orthopedic condition
  • Broken bones as an adult in the past year;
  • Have received neurological treatment, such as Botox, in the past six months;
  • Heart attack, angioplasty, or coronary artery bypass graft in the past six months;
  • Congestive heart failure (NYHA III or IV functional severity);
  • Surgery on back, hip, shoulder, or total joint replacement of hip or knee joint less than two years ago;
  • Respiratory conditions (lung cancer, bronchitis, emphysema, asthma, shortness of breath) not under regular medical care or the patient is medically unstable.
  • Exclusions related to laboratory findings
  • Positive serum β hCG measured at screening;
  • Positive screening tests for hepatitis B (hepatitis B surface antigen [HBsAg] positive, or positive hepatitis B core antibody [total HBcAb] confirmed by a positive viral deoxyribonucleic acid [DNA] polymerase chain reaction [PCR]) or hepatitis C (HepCAb);
  • Positive rapid plasma reagin (RPR);
  • CD4 count < 300/μL;
  • AST/SGOT or ALT/SGPT ≥ 2.0 Upper Limit of Normal (ULN);
  • Platelet count <100,000/μL (<100 x 109/L);
  • Levels of serum IgG <5.65 g/L;
  • Levels of serum IgM < 0.55 g/L;
  • Total neutrophil count <1.5 x 103/μL.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Georgia State University

    Atlanta, Georgia, 30303

  • Multiple Sclerosis Center of Atlanta

    Atlanta, Georgia, 30327

Other trials in United States

About this study

Official title: Effects and Mechanisms of Ocrevus on Ambulatory Functions in People With Relapsing Multiple Sclerosis

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.

Being tested
Ocrelizumab, Platform
Keywords
Mobility; Fall risk; Balance; Multiple sclerosis; T2LV
Medical subject headings
Multiple Sclerosis

What participants receive

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

  • OcrelizumabDrug

    Also called Ocrevus

    Ocrevus will be administered following the FDA's regulations.

  • PlatformDrug

    Also called Other injectable Disease Modification Treatments

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

Study groups in NCT04387734
Study groupRoleWhat they receive
OcrevusExperimentalNot described
Receives: Drug: Ocrelizumab
Other Disease Modifying TreatmentsActive comparatorOther Disease Modifying Treatments will consist of FDA-approved injectable and oral medications for multiple sclerosis.
Receives: Drug: Platform

What is being measured

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

  1. Dynamic Gait Stability

    To quantify dynamic balance of participants during level walking.

    Measured: 12 months

Secondary outcomes (13)

  1. Gait speed

    To quantify the distance covered per second.

    Measured: 12 months

  2. Step length

    The length of the step.

    Measured: 12 months

  3. Step width

    The width of the step.

    Measured: 12 months

  4. Step time

    Time elapsed between heel-strike of the contralateral foot and the successive heel-strike of the ipsilateral foot

    Measured: 12 months

  5. Cadence

    To quantify the number of steps taken within one minute

    Measured: 12 months

  6. Stability index

    Sway index is to characterize the static postural control associated with three sensory systems in people with multiple sclerosis.

    Measured: 12 months

  7. Swing index

    Swing index is another matrix measuring static balance.

    Measured: 12 months

  8. Lower limb muscle strength

    The maximum voluntary muscle strength at bilateral knee and ankle joints.

    Measured: 12 months

  9. Lower limb muscle activity

    The electrical activity of leg muscles during level walking

    Measured: 12 months

  10. Multiple Sclerosis Functional Composite

    The assessment of the disability status based on lower extremity function, upper extremity function, and cognitive function.

    Measured: 12 months

  11. Expanded Disability Status Scale

    Another assessment of the level of disability in people with multiple sclerosis. The Expanded Disability Status Scale score ranges from 0 to 10 (in increments of 0.5). A smaller score indicates a lower level of disability.

    Measured: 12 months

  12. Total cerebral T2 lesion volume

    T2-weighted lesion volume has been used as a measure of disease progression in multiple sclerosis.

    Measured: 12 months

  13. Prospective falls

    The number of fall incidences occurred in everyday living, and the details of each fall (if any), including the date, environment, and possible causes will be recorded using a falls-questionnaire.

    Measured: 12 months

Timeline

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

  1. First posted14 May 2020
  2. Study start5 Feb 2021
  3. Primary completion17 Feb 2025
  4. Study completion30 Sep 2026 (estimated)

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 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04387734
Sponsor's protocol ID
RO-IIS-2019-20273
Acronym
MOBILE-RMS
Status last verified
Jun 2026
First submitted
11 May 2020
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ocrelizumab and Platform in people with Relapsing Multiple Sclerosis, run by Georgia State University at 2 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 9 inclusion and 61 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: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Dynamic Gait Stability (time frame: 12 months). 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 NCT04387734.

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 17 Jun 2026; AzTrials last refreshed its copy on 31 Oct 2026.

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