ML45855
What it found
No result yet.
What was tested
Treatment tested
- Multiple Sclerosis patients who have been on Ocrelizumab will undergo cognitive and fatigue assessments
What it measured
Main measures
Change in global cognitive performance
Baseline to 12 months.
Thinking and memoryChange in fatigue impact (Modified Fatigue Impact Scale, MFIS)
Baseline to 12 months.
Fatigue
Other measures (2)
Change in health-related quality of life (Multiple Sclerosis Quality of Life-54; MSQOL-54, physical and mental composite scores)
Baseline to 12 months
Quality of life (reported by participants)Change in patient-reported physical and mental health (Patient-Reported Outcomes Measurement Information System, 29-item profile; PROMIS-29)
Baseline to 12 months
FatiguePainMood and sleepQuality of life (reported by participants)
Who could take part
MS (type not specified) · 18 to 75
Inclusion Criteria: * 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 Criteria: * 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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 veterans with multiple sclerosis. The evaluation will involve cognitive assessment scales (to assess memory, attention and learning abilities), clinical evaluations (to assess nerve function and ability to move), and patient-reported outcome measures (in which you will answer questions about your tiredness, sleep and how you function in daily life). These assessments will occur at baseline (visit 1), 6 month (Visit-2) and 12 months (visit 3) to track changes over time.
Loading reviews and guidelines…
Related trials
- A Study of C-CAR168 in the Treatment of Autoimmune Diseas…
Phase 1 · Not yet recruiting
Still running
- CN46182
Phase 3 · Running, not recruiting
Still running
- Immune System Effects in Children Born to Women With Mult…
Not yet recruiting
Still running
- A Study of C-CAR168 in the Treatment of Central Nervous S…
Phase 1 · Not yet recruiting
Still running
- B-cell Depletion in Offspring to Women With MS Under Immu…
Status unknown
No result found
- OleroMAX
Phase 3 · Recruiting
Still running
History
Started
Sept 2025
Main results due
Jun 2028
Finished
Jun 2028
Assembled by software from public sources and not checked by people. Each record links to its source. Report an error