Effects of Ocrevus in Relapsing Multiple Sclerosis

  • STATUS
    Recruiting
  • End date
    Sep 28, 2025
  • participants needed
    60
  • sponsor
    Georgia State University
Updated on 28 September 2021

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 platform therapy. Sixty qualified individuals with RMS will be evenly assigned into two groups: Ocrevus and Platform. 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.

Details
Condition Relapsing Multiple Sclerosis
Treatment Ocrelizumab, Platform
Clinical Study IdentifierNCT04387734
SponsorGeorgia State University
Last Modified on28 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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 <
)
\. 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 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/L
\. AST/SGOT or ALT/SGPT 2.0 Upper Limit of Normal (ULN)
\. Platelet count <100,000/L (<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/L
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