Assessing the Effects of Ongoing Ocrelizumab (OCR) Therapy on Fatigue and Cognition in Veterans With Multiple Sclerosis

Korábbi kezelés

• Not on ocrelizumab therapy for at least 6 months prior to study start.
• Currently receiving other disease-modifying therapies for MS in addition to Ocrelizumab.
• Experienced an MS relapse or corticosteroid use within the last 30 months prior to enrollment.
• Concomitant diseases requiring chronic systemic corticosteroid or immunosuppressant use.
• Recent systemic corticosteroid therapy within 4 weeks prior to baseline.
• Prior MS treatments with cyclophosphamide, mitoxantrone, or bone marrow transplant.
• Receipt of live, attenuated, or inactivated/component vaccine within 6 weeks before enrollment.

Más betegség

• History of major psychiatric conditions (severe depression, schizophrenia, bipolar disorder) interfering with assessments.
• Significant cognitive impairment due to non-MS-related conditions (Traumatic brain injury, dementia, other neurodegenerative diseases).
• Other major neurological disorders (e.g., Parkinson's, epilepsy, stroke).
• History of alcohol or substance abuse within the past year.
• Uncontrolled comorbidities (severe cardiovascular disease, diabetes with complications, renal/liver failure).
• Known presence of recurrent or chronic infections (Human Immunodeficiency Virus, syphilis, tuberculosis).
• History or presence of infectious causes of myelopathy (e.g., syphilis, Lyme disease, Human T-lymphotropic virus type 1).
• Active bacterial, viral, fungal, mycobacterial infection requiring recent hospitalization or IV antibiotics.
• History of cancer (except treated basal cell, in situ squamous cell, or resolved cervical carcinoma).
• History of or currently active primary or secondary immunodeficiency.
• Severe allergic or anaphylactic reactions to monoclonal antibodies.
• Systemic autoimmune disorders causing progressive neurological disease (e.g., lupus, Sjögren's).
• Significant uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease.
• History of other neurologic disorders (e.g., progressive multifocal leukoencephalopathy, central nervous system/spinal tumors, hereditary spastic paraparesis, mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes syndrome, neuromyelitis optica-spectrum disorder).

Laborértékek

• Laboratory abnormalities: Positive hepatitis B markers, elevated liver enzymes (AST/ALT ≥2x ULN), cytopenias, low IgG/IgM.

Egyéb

• Patients without a confirmed diagnosis of MS based on McDonald 2017 Criteria.
• Uncorrected vision or hearing impairments interfering with cognitive testing.
• Unable to provide informed consent due to cognitive or legal reasons.
• Pregnant, lactating, or planning to become pregnant during the study period.
• Currently enrolled in other interventional clinical trials affecting cognitive or fatigue outcomes.

• Age 18-75, men and women.
• Confirmed diagnosis of Multiple Sclerosis (MS) (relapsing or progressive forms).
• Expanded Disability Status Scale score between 0 and 7.5.
• On continuous ocrelizumab therapy for at least 1 year.
• Women of childbearing potential: Must agree to remain abstinent or use acceptable contraceptive methods during the study and for 6 months after the. last ocrelizumab dose; must have a negative pregnancy test before enrollment.