NCT06495593
Effects of Ocrelizumab Treatment on Immune Cells in Lymph Nodes in Multiple Sclerosis
Enrolling by Invitation
PHASE4Ages 18–65InterventionalUniversity of California, San FranciscoInvestigator-initiated
~5 participants
Updated 2026-03-27 on ClinicalTrials.gov
What's tested:Ocrelizumab
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Lymphocyte analysis
Measured over 3 months
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- Joseph Sabatino, MD, PhD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Ability to provide written informed consent and be compliant with the study protocol
The treating neurologist's independent medical assessment and decision to initiate the patient on ocrelizumab treatment as most appropriate standard of care for the patient
Diagnosis of RR-MS with Expanded Disability Status Scale (EDSS) 0-5.5 at enrollment
Treatment-naïve (i.e. no prior disease modifying therapy)
Disease duration from the onset of MS symptoms: less than 15 years in patients with an EDSS greater than 5.0 at screening
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive methods during the treatment period and for 6 months after the final dose of ocrelizumab
Exclusion
Diagnosis of secondary progressive MS without relapses for at least 1 year.
Diagnosis of primary progressive MS.
Prior treatment with any disease modifying therapy for MS.
Previous or concurrent treatment with any investigational agent or treatment with any experimental procedure for MS (e.g., treatment for chronic cerebrospinal venous insufficiency).
Known presence of recurrent or chronic infection (e.g., HIV, syphilis, tuberculosis).
History of recurrent aspiration pneumonia requiring antibiotic therapy.
History or known presence of infectious causes of myelopathy (e.g., syphilis, Lyme disease, HTLV-1, herpes zoster myelopathy).
Known active bacterial, viral, fungal, mycobacterial infection, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infection of nail beds) or any major 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.
Pregnant or lactating, or intending to become pregnant during the study
Women of childbearing potential must have a negative serum or urine pregnancy test result within 14 days prior to initiation of study drug.
On systemic anti-coagulation or known blood clotting disorder.
History of or currently active primary or secondary immunodeficiency.
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
History of alcohol or other drug abuse within 24 weeks prior to enrollment.
History or known presence of systemic autoimmune disorders, potentially causing progressive neurologic disease (e.g., lupus, anti-phospholipid antibody syndrome, Sjögren's syndrome, Behçet's disease).
Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study.
Significant, uncontrolled disease, as defined by AMA guidelines or similar, such as cardiovascular (including congestive heart failure - NYHA grade 3 or 4, cardiac arrhythmia), uncontrolled hypertension, pulmonary (including chronic obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus), gastrointestinal, or any other significant disease.
Known presence or history of other neurologic disorders
Systemic corticosteroid therapy within 4 weeks prior to baseline.
Contraindications for, or intolerance to, oral or IV corticosteroids, including IV methylprednisolone, according to the country label, including hypersensitivity to any of the treatment drug constituents.
Previous treatment with cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, or bone marrow transplantation.
Positive serum or urine β-hCG.
Positive for hepatitis B (hepatitis B surface antigen \[HBsAg\] positive or hepatitis B core antibody \[total HBcAb\] confirmed by positive viral DNA polymerase chain reaction \[PCR\]).
AST or ALT more than 2 times the upper limit of normal.
Platelet count below lower limit of normal.
Total white blood cell count, including differential counts, below lower limit of normal.
Absolute neutrophil count below lower limit of normal.
Lymphocyte count below lower level of normal.
Levels of serum IgG 18% below the lower limit of normal (LLN) and levels of serum IgM 8% below the LLN.
Absolute CD4+ and CD8+ counts and CD4:CD8 ratio - within normal limits.
What this trial measures
- Lymphocyte analysis3 months
Percent reduction in B cells and T cell subsets in lymphoid tissue of MS patients following ocrelizumab treatment.