Status:
NOT_YET_RECRUITING
Assessing the Effects of Ongoing Ocrelizumab (OCR) Therapy on Fatigue and Cognition in Veterans With Multiple Sclerosis
Lead Sponsor:
Anza Memon
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This study seeks to assess the effects of long-term ocrelizumab therapy on fatigue (extreme tiredness) as well as cognition (thinking and reasoning skills, such as memory, learning and attention), in ...
Detailed Description
This is a prospective, interventional study involving 30 subjects who have been diagnosed with multiple sclerosis (MS) and being treated with ocrelizumab (OCR) for at least one year. This study will b...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Patients without a confirmed diagnosis of MS based on McDonald 2017 Criteria.
- 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.
- 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).
- 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.
- 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).
- Concomitant diseases requiring chronic systemic corticosteroid or immunosuppressant use.
- 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).
- 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.
- Laboratory abnormalities: Positive hepatitis B markers, elevated liver enzymes (AST/ALT ≥2x ULN), cytopenias, low IgG/IgM.
Key Trial Info
Start Date :
September 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07181811
Start Date
September 30 2025
End Date
June 1 2028
Last Update
September 18 2025
Active Locations (1)
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1
John D. Dingell VA Medical Center
Detroit, Michigan, United States, 48201