Multiple SclerosisML45855NCT07181811
Assessing the Effects of Ongoing Ocrelizumab (OCR) Therapy on Fatigue and Cognition in Veterans With Multiple Sclerosis
A study testing Multiple Sclerosis patients who have been on Ocrelizumab will undergo cognitive and fatigue assessments in people with Multiple Sclerosis, run by Anza Memon at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Multiple Sclerosis patients who have been on Ocrelizumab will undergo cognitive and fatigue assessments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2025to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 27Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
John D. Dingell VA Medical Center
Detroit, Michigan, 48201
Lynn Huber, MBA, 3135763106, lynn.huber@va.gov
Sara Omar, MSc, 313-576-1485, sara.omar@va.gov
About this study
Official title: Assessing the Effects of Ongoing Ocrelizumab (OCR) Therapy on Fatigue and Cognition in Veterans With Multiple Sclerosis: Utilizing Cognitive Assessment Scales, and Patient-Reported Outcome Measures
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.
Read the 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 be performed at the John D. Dingell, VA Medical Center. All participants will require full informed consent prior to any study- related procedures. All aspects of the study and informed consent forms will be reviewed and approved by the institutional Review Board (IRB). MS patients who have been on OCR- for MS treatment, and enrolled in this study will undergo cognitive and fatigue assessments using the Brief International Cognitive Assessment for MS (BICAMS) and the Modified Fatigue Impact Scale (MFIS), respectively. Importantly, the cognitive and fatigue assessments administered in this study are not currently part of the standard clinical care for MS patients on OCR. 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 MS management.
- Conditions
- Multiple Sclerosis
- Being tested
- Multiple Sclerosis patients who have been on Ocrelizumab will undergo cognitive and fatigue assessments
- Keywords
- Veterans, MS, Cognitive assessment, Ocrelizumab, OCR, Modified Fatigue Impact Scale (MFIS), Brief International Cognitive Assessment for MS (BICAMS), multiple sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple Sclerosis patients who have been on Ocrelizumab will undergo cognitive and fatigue assessmentsOther
Also called Modified Fatigue Impact Scale (MFIS), Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Multiple Sclerosis patients who have been on Ocrelizumab will undergo cognitive and fatigue assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in global cognitive performance
Global cognitive performance will be assessed using a composite z-score, derived from 3 standardized tests:
- 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.
- 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.
- 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.
Measured: 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).
Measured: 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)
Change in the MSQOL-54 physical health composite and mental health composite scores (each transformed 0-100, higher = better). Scores are computed per MSQOL-54 scoring manual by transforming subscale raw scores to 0-100 scales and averaging the relevant subscales to produce the two composite scores. The outcome is the difference between baseline and 12-month composite scores for each domain; positive values indicate improvement in health-related quality of life.
Measured: Baseline to 12 months
Change in patient-reported physical and mental health (Patient-Reported Outcomes Measurement Information System, 29-item profile; PROMIS-29)
Change in PROMIS-29 domain T-scores (physical function, fatigue, anxiety, depression, sleep disturbance, social roles, pain interference) and pain intensity (0-10).
PROMIS domain scores are reported as T-scores (mean=50, SD=10); higher scores indicate greater symptom burden for negative domains (fatigue, pain, etc.) and better health for positive domains (physical function, social roles). The outcome will report domain-specific changes from baseline to 12 months; directionality is indicated per domain.
Higher = worse for negative domains (anxiety, depression, fatigue, pain interference, sleep disturbance, pain intensity).
Higher = better for positive domains (physical function, social roles).
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start30 Sep 2025 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients who have been on Ocrelizumab for at least one year.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anza Memon
- Sponsor type
- US federal agency
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor-investigator, Anza Memon, John D. Dingell VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181811
- Sponsor's protocol ID
- 1841354-3
- Other IDs
- ML45855
- Acronym
- ML45855
- Status last verified
- Sep 2025
- First submitted
- 5 Sep 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. The primary reasons are participant confidentiality and institutional restrictions. Although data will be de-identified for analysis, there remains a risk of re-identification, especially in small and sensitive populations such as veterans. In addition, participants will not consent to broad data sharing outside the research team.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effects of Ongoing Ocrelizumab (OCR) Therapy on Fatigue and Cognition in Veterans With Multiple Sclerosis: Utilizing Cognitive Assessment Scales, and Patient-Reported Outcome Measures
- ClinicalTrials.gov ID
- NCT07181811
- Acronym / sponsor ID
- ML45855 / 1841354-3
- Conditions
- Multiple Sclerosis
- Keywords
- Veterans, MS, Cognitive assessment, Ocrelizumab, OCR, Modified Fatigue Impact Scale (MFIS), Brief International Cognitive Assessment for MS (BICAMS), multiple sclerosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Anza MemonUS federal agency
- Collaborators
- Genentech, Inc.
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 be performed at the John D. Dingell, VA Medical Center. All participants will require full informed consent prior to any study- related procedures. All aspects of the study and informed consent forms will be reviewed and approved by the institutional Review Board (IRB). MS patients who have been on OCR- for MS treatment, and enrolled in this study will undergo cognitive and fatigue assessments using the Brief International Cognitive Assessment for MS (BICAMS) and the Modified Fatigue Impact Scale (MFIS), respectively. Importantly, the cognitive and fatigue assessments administered in this study are not currently part of the standard clinical care for MS patients on OCR. 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 MS management.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients who have been on Ocrelizumab for at least one year.
| Arm | Type | Receives |
|---|---|---|
| Ocrelizumab Arm | Experimental | Other: Multiple Sclerosis patients who have been on Ocrelizumab will undergo cognitive and fatigue assessmentsThis 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (27 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiple Sclerosis patients who have been on Ocrelizumab will undergo cognitive and fatigue assessmentsAlso: Modified Fatigue Impact Scale (MFIS), Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)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. | Other | Ocrelizumab Arm |
Primary outcome
Change in global cognitive performance
Time frame: Baseline to 12 months.
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.
Change in fatigue impact (Modified Fatigue Impact Scale, MFIS)
Time frame: Baseline to 12 months.
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).
2 secondary outcomes
Change in health-related quality of life (Multiple Sclerosis Quality of Life-54; MSQOL-54, physical and mental composite scores)
Time frame: Baseline to 12 months
Change in patient-reported physical and mental health (Patient-Reported Outcomes Measurement Information System, 29-item profile; PROMIS-29)
Time frame: Baseline to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. The primary reasons are participant confidentiality and institutional restrictions. Although data will be de-identified for analysis, there remains a risk of re-identification, especially in small and sensitive populations such as veterans. In addition, participants will not consent to broad data sharing outside the research team.
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiple Sclerosis patients who have been on Ocrelizumab will undergo cognitive and fatigue assessments in people with Multiple Sclerosis, run by Anza Memon at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anza Memon, M.D, FAAN (313-576-0298, anza.memon@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in global cognitive performance (time frame: Baseline to 12 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.