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This study evaluates the impact of ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) participants that are very early in the course of their disease using clinical and magnetic resonance imaging (MRI) outcomes. The study also assesses changes in disease using monitoring techniques including digital biometric device use, biomarker analysis and non-conventional MRI. Select outcomes in the ofatumumab treated group will be compared to a group of Healthy participants to determine if there are similarities between the groups after the patients with MS undergo treatment with ofatumumab.
The study is an open-label, multi-center, prospective 18-month study in 119 MS participants with early RRMS (defined as within 6 months of diagnosis of clinically definite RRMS) and who are treatment naïve. It is designed to determine if RRMS participants treated with 20 mg subcutaneous monthly ofatumumab during the earliest part of their disease will benefit from the use of ofatumumab as their first disease modifying therapy. Additionally, RRMS patients will be compared to age- and sex-matched healthy participants (n=61) for select outcomes to observe similarities and differences between the groups.
After giving consent, participants have a 28-day screening/qualification period. If they qualify to continue, they start study measures including assessments of clinical and magnetic resonance imaging (MRI) metrics and use of a digital monitoring watch. Additionally, samples are collected for laboratory and biomarker analysis. RRMS participants begin treatment with ofatumumab for the next 18 months. Healthy participants undergo similar assessments; however they do not receive any treatment during the course of the study. Over the 18 months, participants have regular clinical visits with assessments and sample collection. After 18 months in the trial, participants in both groups have the option to enter into a 12-month extension (up to 30 months total in study) to collect further information on long-term clinical and MRI outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ofatumumab | Experimental | Ofatumumab will be provided in an autoinjector for subcutaneous administration. Dosing regimen for this study is an initial dose of 20mg at Baseline/Week 0, followed by Week 1, 2 and every month thereafter, beginning at Week 4 (Month 1) until Month 18. There will be an optional extension of dosing through month 30. |
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| Healthy Control | No Intervention | Healthy Control arm will be age- and sex-matched subjects (to the ofatumumab treated arm) and will not receive a study treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ofatumumab | Drug | 20mg subcutaneous injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving NEDA-3 (No Evidence of Disease Activity-3) | A participant is considered as achieved NEDA-3 if they were:
| Month 6 to month 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Confirmed MS Relapses in Months 6 to 18 | Relapses are recurrences of a disease activity after a recovery. A confirmed MS relapse is one accompanied by a clinically relevant change in the EDSS , i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores (FSs) or 2 points on one FS, excluding changes involving bowel/bladder or cerebral FS compared to the previous available rating (the last EDSS rating that did not occur during a relapse). Expanded Disability Status Scale (EDSS) ranges from 0 to 10 with higher values indicating increased disability. Confirmation of MS relapse was done centrally. As per protocol and SAP only evaluated on the ofatumumab participants. |
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Key Inclusion Criteria:
Participants eligible for inclusion in this study must meet all of the following criteria:
Signed informed consent must be obtained prior to participation in the study
Age 18-35 years
Patients in the healthy control arm eligible for inclusion must fulfill the following criteria:
Able to obtain MRI (HC with abnormal MRI at Screening will be excluded) and use wearable device
Able to provide blood sample (no CSF will be collected in HC)
Patients in the ofatumumab-treated arm eligible for inclusion must fulfill the following criteria:
Diagnosis of RRMS per McDonald Criteria (2010/2017)
Within 6 months of diagnosis of clinically definite MS (CDMS)
EDSS 0-3.0 (Inclusive)
Treatment-naïve to MS DMT
Able to obtain MRI and attend study visits at sites
Able to use wearable device
Able to provide blood sample (and CSF for sub-group n=15)
Key Exclusion Criteria:
Participants in the healthy control arm meeting any of the following criteria are not eligible for inclusion in this study:
Confounding medical condition as determined by the investigator
RRMS patients fulfilling any of the following exclusion criteria are not eligible for inclusion in this study:
Diseases other than multiple sclerosis responsible for the clinical or MRI presentation
Patients with neuromyelitis optica, Radiologic/ Clinically Isolated Syndrome, Secondary Progressive or Primary Progressive MS diagnosis
Use of experimental or investigational drugs for MS
Previous use of Disease Modifying Therapy (DMT) or chemotherapeutic medications for MS
Relapse between screening and Baseline visits
Known sensitivity to gadolinium; patients with chronic, severe kidney disease
Known history of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes
CNS anomalies that are better accounted for by another disease process or MRI anomalies causing clinically apparent impairments
Known active malignancies
Pregnant or nursing (lactating) women
Females of childbearing potential (all women physiologically capable of becoming pregnant) should use effective contraception while receiving ofatumumab and for 6 months after the last treatment of ofatumumab
Patients with an active chronic disease (or stable but treated with immune therapy) of the immune system other than MS or with immunodeficiency syndrome
Patients with active infections including systemic bacterial, viral (including SARS-CoV-2/COVID-19) or fungal infections, or known to have AIDS or to test positive for HIV antibody at Screening
Patients with neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML), or confirmed PML
Patients with IgG or IgM levels below LLN at Screening
Patients that have received any live or live-attenuated vaccines within 4 weeks prior to first dose of study drug administration
Patients at risk of developing or having reactivation of hepatitis
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD First Research | Chandler | Arizona | 85226 | United States | ||
| Barrow Neurological Clinics at St Josephs Hospital and MC |
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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The trial consists of a 4 week screening period before first treatment (day 1), an 18 month open-label treatment phase , an optional 12 month open-label extension and a 100 day safety follow-up. The Open-Label extension and safety follow up were still ongoing at the date of data cut-off.
Participants were enrolled in 36 sites in the United States
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| ID | Title | Description |
|---|---|---|
| FG000 | Ofatumumab | Ofatumumab 20 mg subcutaneous injections at Week 0, 1, 2 and monthly thereafter starting at Week 4 until Month 18 |
| FG001 | Healthy Control | Healthy age- and sex-matched participants will not receive a study treatment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 14, 2023 | Feb 2, 2026 |
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| Month 6 to month 18 |
| Participant Based Annualized Relapse Rate (ARR) | ARR (participant-based) is calculated at the participant level as [(number of confirmed MS relapses in Months 6 to 18) / (number of days in Months 6 to 18)] x 365.25. As per protocol and SAP only evaluated on the ofatumumab participants. | Month 6 to month 18 |
| Group Based Annualized Relapse Rate (ARR) | ARR (group-based) is calculated at the group level as [(total number of confirmed MS relapses in Months 6 to 18 for all participants within the ofatumumab-treated cohort) / (total number of days in Months 6 to 18 for all participants within the ofatumumab-treated cohort)] x 365.25. As per protocol and SAP only evaluated on the ofatumumab participants. | Month 6 to month 18 |
| Percentage of Participants That Were 3-month Disability Progression-free | 3-month clinical disability progression-free was defined as no clinical disability progression as measured by EDSS (global assessment scale), where 3-month confirmed clinical disability progression was defined as an increase from Month 6 in EDSS sustained for at least 3 months. If a participant fulfilled the clinical disability progression criteria based on the single EDSS assessment at Month 18, it was considered a confirmed clinical disability progression (sustainment for at least 3 months was not required). If a participant died due to MS , it was considered a confirmed clinical disability progression regardless of the Month 6 EDSS or change in EDSS. Expanded Disability Status Scale (EDSS) ranges from 0 to 10 with higher values indicating increased disability. As per protocol and SAP only evaluated on the ofatumumab participants. | Month 6 to month 18 |
| Percentage of Participants With NEDA (No Evidence of Disease Activity) - Clinical | A participant is considered as achieved NEDA-Clinical if the participant has not had a confirmed MS relapse in Months 6 to 18 and no 3-month confirmed clinical disability progression in Months 6 to 18 (based on change from Month 6 in EDSS). Expanded Disability Status Scale (EDSS) ranges from 0 to 10 with higher values indicating increased disability. As per protocol and SAP only evaluated on the ofatumumab participants. | Month 6 to month 18 |
| Number of Participants With NEDA (No Evidence of Disease Activity) - Radiological | A participant is considered as achieved NEDA-radiological if the participant has had no Gd+ lesions on any MRI scan after Month 6, or new/enlarging T2 lesions compared to Month 6 on any MRI scan after Month 6 (MRI activity-free). Scheduled and unscheduled assessments are considered. As per protocol and SAP only evaluated on the ofatumumab participants. | Month 6 to month 18 |
| Change From Baseline in Gd+ Lesion Count | Change in the number of gadolinium enhancing lesions will be measured by Magnetic Resonance Imaging (MRI). Each MRI scan will be previewed by a local neuroradiologist. The quality of each scan performed will be assessed by a central MRI reading center. | Baseline to Month 18 and 30 |
| Change From Baseline in Gd+ Lesion Volume | Change in size of gadolinium enhancing lesions will be measured by Magnetic Resonance Imaging (MRI). Each MRI scan will be previewed by a local neuroradiologist. The quality of each scan performed will be assessed by a central MRI reading center. | Baseline to Month 18 and 30 |
| Change From Baseline in New/Enlarging T2 Lesion Count | Change in the number of new/enlarging T2 lesions will be measured by Magnetic Resonance Imaging (MRI). Each MRI scan will be previewed by a local neuroradiologist. The quality of each scan performed will be assessed by a central MRI reading center. | Baseline to Month 18 and 30 |
| Change From Baseline in T2 Lesion Volume | Change in size of T2 lesions will be measured by Magnetic Resonance Imaging (MRI). Each MRI scan will be previewed by a local neuroradiologist. The quality of each scan performed will be assessed by a central MRI reading center. | Baseline to Month 18 and 30 |
| Change From Baseline for NeuroQOL | The NeuroQOL is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The following domains will be measured. Physical Health, Mental Health, Social Health. Scales can be scored by summing the values of the response to each item to develop a total raw score. | Baseline to Month 18 and 30 |
| Change From Baseline for Patient Determined Disease Steps (PDDS) | The PDDS is a standardized rating scale which is a self-assessment scale of functional disability in multiple sclerosis patients primarily based on ambulation. The questionnaire contains 1 question which is scored ranging from 0 (normal) to 8 (bedridden). A score of 0 to 2 indicates mild disability; a score of 3 to 5 indicates moderate disability; a score of 6 to 8 indicates severe disability. | Baseline to Month 18 and 30 |
| Brain Volume Loss (BVL) Assessment (Whole Brain and Regional) | Brain volume loss is a marker of progressive loss of brain structure and function. It is a predictor of disability progression. Evaluate the effect of ofatumumab vs healthy controls on 1) whole brain and regional atrophy measured at month 18/30 after re-baseline at 6 months; and 2) regional atrophy measured 18/30 months from Baseline | Month 6 to Month 18 and 30 |
| Number of Participants With Treatment Emergent Adverse Events | Adverse event monitoring should be continued following the last dose of study treatment until B cells are repleted. Repletion is defined as a concentration > the participant's baseline value or > the lower limit of normal, whichever is observed first. Other safety assessments (physical exam, vital signs, etc) that meet the definition of an adverse event or are considered clinically relevant by the investigator will be reported as an adverse event. | Baseline up to approximately Month 30 |
| Change From Baseline in New Unenhancing T1 Lesion Number | Change in the number of new unenhancing T1 lesions will be measured by Magnetic Resonance Imaging (MRI). Each MRI scan will be previewed by a local neuroradiologist. The quality of each scan performed will be assessed by a central MRI reading center. | Baseline to Month 18 and 30 |
| Change From Baseline in T1 Unenhancing Lesion Volume | Change in the size of T1 unenhancing lesions will be measured by Magnetic Resonance Imaging (MRI). Each MRI scan will be previewed by a local neuroradiologist. The quality of each scan performed will be assessed by a central MRI reading center. | Baseline to Month 18 and 30 |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| Arizona Neuroscience Research LLC | Phoenix | Arizona | 85032 | United States |
| Keck School of Medicine | Los Angeles | California | 90033 | United States |
| Lundquist Inst BioMed at Harbor | Torrance | California | 90509-2910 | United States |
| Regina Berkovich MD PhD Inc | West Hollywood | California | 90048 | United States |
| UC Health Neuroscience Ctr | Aurora | Colorado | 80045 | United States |
| MedStar Health | Washington D.C. | District of Columbia | 20007 | United States |
| Neurology of Central FL Res Ctr | Altamonte Springs | Florida | 32714 | United States |
| First Choice Neurology | Boca Raton | Florida | 33486 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| Neurology Associates PA | Maitland | Florida | 32751 | United States |
| Orlando Health Clinical Trials | Orlando | Florida | 32806 | United States |
| Emerald Coast Neurology | Pensacola | Florida | 32514 | United States |
| Tallahassee Neurological Clinic | Tallahassee | Florida | 32308 | United States |
| University Of South Florida | Tampa | Florida | 33612 | United States |
| Shepherd Center | Atlanta | Georgia | 30309 | United States |
| Ochsner Cancer Institute | New Orleans | Louisiana | 70121 | United States |
| University of Massachusetts Medical School | Worcester | Massachusetts | 01655 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202-2689 | United States |
| Renown Institute for Neurosciences | Reno | Nevada | 89521 | United States |
| Neuroscience Institute at Hackensack | Hackensack | New Jersey | 07601 | United States |
| University of New Mexico | Albuquerque | New Mexico | 87131-0001 | United States |
| Velocity Clinical Research | Raleigh | North Carolina | 27607 | United States |
| Neurology Diagnostics Inc | Dayton | Ohio | 45408 | United States |
| Multiple Sclerosis Center of Excellence of OMRF | Oklahoma City | Oklahoma | 73104 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107-5098 | United States |
| Sibyl Wray MD Neurology PC | Knoxville | Tennessee | 37922 | United States |
| Univ of Texas Southwest Med Center | Dallas | Texas | 75390-9034 | United States |
| UT Health Science Center | Houston | Texas | 77030 | United States |
| Lonestar Neurology of San Antonio | San Antonio | Texas | 78258 | United States |
| Evergreen Health Multiple Sclerosis Center | Kirkland | Washington | 98034 | United States |
| MultiCare Neuroscience Center of Washington | Tacoma | Washington | 98405 | United States |
| West Virginia University Hospital | Morgantown | West Virginia | 26506 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Caribbean Center for Clinical Research, Inc | Guaynabo | 00968 | Puerto Rico |
| COMPLETED | Completed 18 month open-label treatment phase |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ofatumumab | Ofatumumab 20 mg subcutaneous injections at Week 0, 1, 2 and monthly thereafter starting at Week 4 until Month 18 |
| BG001 | Healthy Control | Healthy age- and sex-matched participants will not receive a study treatment |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving NEDA-3 (No Evidence of Disease Activity-3) | A participant is considered as achieved NEDA-3 if they were:
| The Modified Full Analysis Set (mFAS) included all participants who received any study drug except for those who discontinued treatment prematurely prior to Month 18 for reasons other than lack of efficacy or death, or those who completed their Month 18 visit but missed relapse/EDSS/MRI at Month 6, 12 or 18, unless they showed disease activity. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 6 to month 18 |
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| Secondary | Number of Confirmed MS Relapses in Months 6 to 18 | Relapses are recurrences of a disease activity after a recovery. A confirmed MS relapse is one accompanied by a clinically relevant change in the EDSS , i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores (FSs) or 2 points on one FS, excluding changes involving bowel/bladder or cerebral FS compared to the previous available rating (the last EDSS rating that did not occur during a relapse). Expanded Disability Status Scale (EDSS) ranges from 0 to 10 with higher values indicating increased disability. Confirmation of MS relapse was done centrally. As per protocol and SAP only evaluated on the ofatumumab participants. | The Full Analysis Set (FAS) included all enrolled participants who received any study drug. | Posted | Number | relapses | Month 6 to month 18 |
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| Secondary | Participant Based Annualized Relapse Rate (ARR) | ARR (participant-based) is calculated at the participant level as [(number of confirmed MS relapses in Months 6 to 18) / (number of days in Months 6 to 18)] x 365.25. As per protocol and SAP only evaluated on the ofatumumab participants. | The Full Analysis Set (FAS) included all enrolled participants who received any study drug. | Posted | Mean | Full Range | relapses/ participant-year | Month 6 to month 18 |
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| Secondary | Group Based Annualized Relapse Rate (ARR) | ARR (group-based) is calculated at the group level as [(total number of confirmed MS relapses in Months 6 to 18 for all participants within the ofatumumab-treated cohort) / (total number of days in Months 6 to 18 for all participants within the ofatumumab-treated cohort)] x 365.25. As per protocol and SAP only evaluated on the ofatumumab participants. | The Full Analysis Set (FAS) included all enrolled participants who received any study drug. | Posted | Number | relapses/ participant-year | Month 6 to month 18 |
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| Secondary | Percentage of Participants That Were 3-month Disability Progression-free | 3-month clinical disability progression-free was defined as no clinical disability progression as measured by EDSS (global assessment scale), where 3-month confirmed clinical disability progression was defined as an increase from Month 6 in EDSS sustained for at least 3 months. If a participant fulfilled the clinical disability progression criteria based on the single EDSS assessment at Month 18, it was considered a confirmed clinical disability progression (sustainment for at least 3 months was not required). If a participant died due to MS , it was considered a confirmed clinical disability progression regardless of the Month 6 EDSS or change in EDSS. Expanded Disability Status Scale (EDSS) ranges from 0 to 10 with higher values indicating increased disability. As per protocol and SAP only evaluated on the ofatumumab participants. | The Modified Full Analysis Set (mFAS) included all participants who received any study drug except for those who discontinued treatment prematurely prior to Month 18 for reasons other than lack of efficacy or death, or those who completed their Month 18 visit but missed relapse/EDSS/MRI at Month 6, 12 or 18, unless they showed disease activity. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 6 to month 18 |
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| Secondary | Percentage of Participants With NEDA (No Evidence of Disease Activity) - Clinical | A participant is considered as achieved NEDA-Clinical if the participant has not had a confirmed MS relapse in Months 6 to 18 and no 3-month confirmed clinical disability progression in Months 6 to 18 (based on change from Month 6 in EDSS). Expanded Disability Status Scale (EDSS) ranges from 0 to 10 with higher values indicating increased disability. As per protocol and SAP only evaluated on the ofatumumab participants. | The Modified Full Analysis Set (mFAS) included all participants who received any study drug except for those who discontinued treatment prematurely prior to Month 18 for reasons other than lack of efficacy or death, or those who completed their Month 18 visit but missed relapse/EDSS/MRI at Month 6, 12 or 18, unless they showed disease activity. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 6 to month 18 |
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| Secondary | Number of Participants With NEDA (No Evidence of Disease Activity) - Radiological | A participant is considered as achieved NEDA-radiological if the participant has had no Gd+ lesions on any MRI scan after Month 6, or new/enlarging T2 lesions compared to Month 6 on any MRI scan after Month 6 (MRI activity-free). Scheduled and unscheduled assessments are considered. As per protocol and SAP only evaluated on the ofatumumab participants. | The Modified Full Analysis Set (mFAS) included all participants who received any study drug except for those who discontinued treatment prematurely prior to Month 18 for reasons other than lack of efficacy or death, or those who completed their Month 18 visit but missed relapse/EDSS/MRI at Month 6, 12 or 18, unless they showed disease activity. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 6 to month 18 |
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| Secondary | Change From Baseline in Gd+ Lesion Count | Change in the number of gadolinium enhancing lesions will be measured by Magnetic Resonance Imaging (MRI). Each MRI scan will be previewed by a local neuroradiologist. The quality of each scan performed will be assessed by a central MRI reading center. | Not Posted | Feb 2027 | Baseline to Month 18 and 30 | Participants | ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Gd+ Lesion Volume | Change in size of gadolinium enhancing lesions will be measured by Magnetic Resonance Imaging (MRI). Each MRI scan will be previewed by a local neuroradiologist. The quality of each scan performed will be assessed by a central MRI reading center. | Not Posted | Feb 2027 | Baseline to Month 18 and 30 | Participants | ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in New/Enlarging T2 Lesion Count | Change in the number of new/enlarging T2 lesions will be measured by Magnetic Resonance Imaging (MRI). Each MRI scan will be previewed by a local neuroradiologist. The quality of each scan performed will be assessed by a central MRI reading center. | Not Posted | Feb 2027 | Baseline to Month 18 and 30 | Participants | ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in T2 Lesion Volume | Change in size of T2 lesions will be measured by Magnetic Resonance Imaging (MRI). Each MRI scan will be previewed by a local neuroradiologist. The quality of each scan performed will be assessed by a central MRI reading center. | Not Posted | Feb 2027 | Baseline to Month 18 and 30 | Participants | ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline for NeuroQOL | The NeuroQOL is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The following domains will be measured. Physical Health, Mental Health, Social Health. Scales can be scored by summing the values of the response to each item to develop a total raw score. | Not Posted | Feb 2027 | Baseline to Month 18 and 30 | Participants | ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline for Patient Determined Disease Steps (PDDS) | The PDDS is a standardized rating scale which is a self-assessment scale of functional disability in multiple sclerosis patients primarily based on ambulation. The questionnaire contains 1 question which is scored ranging from 0 (normal) to 8 (bedridden). A score of 0 to 2 indicates mild disability; a score of 3 to 5 indicates moderate disability; a score of 6 to 8 indicates severe disability. | Not Posted | Feb 2027 | Baseline to Month 18 and 30 | Participants | ||||||||||||||||||||||||||||||
| Secondary | Brain Volume Loss (BVL) Assessment (Whole Brain and Regional) | Brain volume loss is a marker of progressive loss of brain structure and function. It is a predictor of disability progression. Evaluate the effect of ofatumumab vs healthy controls on 1) whole brain and regional atrophy measured at month 18/30 after re-baseline at 6 months; and 2) regional atrophy measured 18/30 months from Baseline | Not Posted | Feb 2027 | Month 6 to Month 18 and 30 | Participants | ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events | Adverse event monitoring should be continued following the last dose of study treatment until B cells are repleted. Repletion is defined as a concentration > the participant's baseline value or > the lower limit of normal, whichever is observed first. Other safety assessments (physical exam, vital signs, etc) that meet the definition of an adverse event or are considered clinically relevant by the investigator will be reported as an adverse event. | Not Posted | Feb 2027 | Baseline up to approximately Month 30 | Participants | ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in New Unenhancing T1 Lesion Number | Change in the number of new unenhancing T1 lesions will be measured by Magnetic Resonance Imaging (MRI). Each MRI scan will be previewed by a local neuroradiologist. The quality of each scan performed will be assessed by a central MRI reading center. | Not Posted | Feb 2027 | Baseline to Month 18 and 30 | Participants | ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in T1 Unenhancing Lesion Volume | Change in the size of T1 unenhancing lesions will be measured by Magnetic Resonance Imaging (MRI). Each MRI scan will be previewed by a local neuroradiologist. The quality of each scan performed will be assessed by a central MRI reading center. | Not Posted | Feb 2027 | Baseline to Month 18 and 30 | Participants |
From baseline up to approximately month 18
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ofatumumab-Treated | Ofatumumab-Treated | 0 | 119 | 8 | 119 | 99 | 119 |
| EG001 | Healthy Control | Healthy Control | 0 | 61 | 3 | 61 | 27 | 61 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumopericardium | Cardiac disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Perforation bile duct | Hepatobiliary disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA (28.0) | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (28.0) | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Bell's palsy | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Multiple sclerosis pseudo relapse | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (28.0) | Systematic Assessment |
| |
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (28.0) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA (28.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (28.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (28.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (28.0) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | + 1 862 778 8300 | Novartis.email@Novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 22, 2025 | Feb 2, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C527517 | ofatumumab |
Not provided
Not provided
Not provided
| Female |
|
| Undifferentiated |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|