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

NCT07181811 | Not Yet Recruiting DMC

• 2 other identifiers: 1841354-3ML45855
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Multiple Sclerosis

Keywords

Veterans; MS; Cognitive assessment; Ocrelizumab; OCR; Modified Fatigue Impact Scale (MFIS); Brief International Cognitive Assessment for MS (BICAMS); multiple sclerosis

Outcome Measures

Primary Outcomes (2)

• Change in global cognitive performance

  Global cognitive performance will be assessed using a composite z-score, derived from 3 standardized tests: 1. CVLT (California Verbal Learning Test): Measures verbal learning and memory. Immediate Recall Max score= 80, Min = 0. Short and Long-Delay Recall: Max = 16 each, Min = 0. Recognition: Max = 16, Min = 0. Higher scores = better memory and learning ability. Lower scores = memory/learning impairment. 2. BVMT-R (Brief Visuospatial Memory Test-Revised): Measures visuospatial learning/ memory; 6 abstract designs × 3 learning trials. Max total learning = 36, Min = 0. Delayed Recall: Max = 12, Min = 0. Recognition: Max = 6, Min = 0. Higher = better visuospatial memory. Lower = difficulty in visual memory. 3. SDMT (Symbol Digit Modalities Test): Measures information processing speed, attention, working memory. Max = 110, Min = 0. Higher = better processing, Lower = slower processing Individual raw scores will be standardized, averaged, and compared between baseline and 12 months.

  Baseline to 12 months.

• Change in fatigue impact (Modified Fatigue Impact Scale, MFIS)

  Change in total score on the Modified Fatigue Impact Scale (MFIS; 21 items). Item responses range 0-4 and total score ranges 0-84, with higher scores indicating greater fatigue impact. The outcome is the difference between MFIS total at baseline and over a 12-month period; higher score = greater fatigue impact (worse) and lower score = less fatigue impact (better).

  Baseline to 12 months.

Secondary Outcomes (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

• Change in patient-reported physical and mental health (Patient-Reported Outcomes Measurement Information System, 29-item profile; PROMIS-29)

  Baseline to 12 months

Study Arms (1)

Ocrelizumab Arm

EXPERIMENTAL

This is a prospective, interventional study involving 30 subjects who have been diagnosed with multiple sclerosis and being treated with Ocrelizumab for at least one year.

Other: Multiple Sclerosis patients who have been on Ocrelizumab will undergo cognitive and fatigue assessments

Interventions

Multiple Sclerosis patients who have been on Ocrelizumab will undergo cognitive and fatigue assessments OTHER

The cognitive and fatigue assessments administered in this study are not currently part of the standard clinical care for multiple sclerosis patients on Ocrelizumab. By prospectively assigning participants to undergo these additional assessments, this aspect of the study is considered investigational, and findings may contribute to clinical decision-making regarding the incorporation of cognitive and fatigue assessments into routine management of multiple sclerosis conditions.

Also known as: Modified Fatigue Impact Scale (MFIS), Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)

Ocrelizumab Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Anza Memon: lead
• Genentech, Inc.: collaborator

Study Sites (1)

John D. Dingell VA Medical Center

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Anza Memon, M.D, FAAN

CONTACT

313-576-0298; anza.memon@va.gov

Sara Omar, MSc.

CONTACT

3135761485; sara.omar@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff Neurologist- John D. Dingell VAMC

Model Details: Patients who have been on Ocrelizumab for at least one year.

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 18, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)