Relapse Remitting Multiple SclerosisPhase 4AGNOSNCT05084638
Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls.
A Phase 4 study testing Ofatumumab in people with Relapse Remitting Multiple Sclerosis, run by Novartis Pharmaceuticals at 36 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Relapse Remitting Multiple Sclerosis
- What is being tested?
- Ofatumumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 36 sitesin 2 countries
- Study dates
- 25 Jan 2022to 11 Feb 2026
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Show all 14Show fewer
- 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)
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
36 sites in 2 countries.
36 sites in 2 countries
United States35 sites
University of New Mexico
Albuquerque, New Mexico, 87131-0001
Neurology of Central FL Res Ctr
Altamonte Springs, Florida, 32714
Shepherd Center
Atlanta, Georgia, 30309
UC Health Neuroscience Ctr
Aurora, Colorado, 80045
First Choice Neurology
Boca Raton, Florida, 33486
MD First Research
Chandler, Arizona, 85226
Univ of Texas Southwest Med Center
Dallas, Texas, 75390-9034
Neurology Diagnostics Inc
Dayton, Ohio, 45408
Henry Ford Hospital
Detroit, Michigan, 48202-2689
University of Florida
Gainesville, Florida, 32610
Neuroscience Institute at Hackensack
Hackensack, New Jersey, 07601
UT Health Science Center
Houston, Texas, 77030
Evergreen Health Multiple Sclerosis Center
Kirkland, Washington, 98034
Sibyl Wray MD Neurology PC
Knoxville, Tennessee, 37922
Keck School of Medicine
Los Angeles, California, 90033
Neurology Associates PA
Maitland, Florida, 32751
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
West Virginia University Hospital
Morgantown, West Virginia, 26506
Ochsner Cancer Institute
New Orleans, Louisiana, 70121
Multiple Sclerosis Center of Excellence of OMRF
Oklahoma City, Oklahoma, 73104
Orlando Health Clinical Trials
Orlando, Florida, 32806
Emerald Coast Neurology
Pensacola, Florida, 32514
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107-5098
Barrow Neurological Clinics at St Josephs Hospital and MC
Phoenix, Arizona, 85013
Arizona Neuroscience Research LLC
Phoenix, Arizona, 85032
Velocity Clinical Research
Raleigh, North Carolina, 27607
Renown Institute for Neurosciences
Reno, Nevada, 89521
Lonestar Neurology of San Antonio
San Antonio, Texas, 78258
MultiCare Neuroscience Center of Washington
Tacoma, Washington, 98405
Tallahassee Neurological Clinic
Tallahassee, Florida, 32308
University Of South Florida
Tampa, Florida, 33612
Lundquist Inst BioMed at Harbor
Torrance, California, 90509-2910
MedStar Health
Washington D.C., District of Columbia, 20007
Regina Berkovich MD PhD Inc
West Hollywood, California, 90048
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
Puerto Rico1 site
Caribbean Center for Clinical Research, Inc
Guaynabo, 00968
About this study
Official title: AGNOS: An 18-month, Open-label, Multi-Center Phase IV Study to Assess the Effect of Ofatumumab 20mg SC Monthly in Treatment Naïve, Very Early Relapsing Remitting Multiple Sclerosis Patients Benchmarked Against Healthy Controls on Select Outcomes.
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.
Read the detailed description
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.
- Conditions
- Relapse Remitting Multiple Sclerosis
- Being tested
- Ofatumumab
- Keywords
- early relapsing multiple sclerosis, ofatumumab, healthy control, treatment naïve, young adult population, MS-related disability, biomarker, MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OfatumumabDrug
Also called OMB157
20mg subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ofatumumab |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving NEDA-3 (No Evidence of Disease Activity-3)
A participant is considered as achieved NEDA-3 if they were:
- relapse-free, defined as no confirmed relapses in month 6 to 18.
- 3-month clinical disability progression-free, defined as no clinical disability progression as measured by EDSS in month 6 to 18.
- MRI activity-free, defined as 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 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.
Measured: Month 6 to month 18
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Month 18 and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start25 Jan 2022
- Primary completion4 Feb 2025
- Study completion11 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Relapse Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084638
- Sponsor's protocol ID
- COMB157GUS10
- Acronym
- AGNOS
- Status last verified
- Feb 2026
- First submitted
- 7 Oct 2021
- Last updated
- 27 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AGNOS: An 18-month, Open-label, Multi-Center Phase IV Study to Assess the Effect of Ofatumumab 20mg SC Monthly in Treatment Naïve, Very Early Relapsing Remitting Multiple Sclerosis Patients Benchmarked Against Healthy Controls on Select Outcomes.
- ClinicalTrials.gov ID
- NCT05084638
- Acronym / sponsor ID
- AGNOS / COMB157GUS10
- Conditions
- Relapse Remitting Multiple Sclerosis
- Keywords
- early relapsing multiple sclerosis, ofatumumab, healthy control, treatment naïve, young adult population, MS-related disability, biomarker, MRI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 4 Feb 2025 (actual)
- Study completion
- 11 Feb 2026 (actual)
- First posted
- 20 Oct 2021 (actual)
- Results
- Posted 27 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ofatumumab | Experimental | Drug: OfatumumabOfatumumab 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. |
| 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (20 listed)
- 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
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 |
|---|---|---|
| OfatumumabAlso: OMB15720mg subcutaneous injection | Drug | Ofatumumab |
Primary outcome
Percentage of Participants Achieving NEDA-3 (No Evidence of Disease Activity-3)
Time frame: Month 6 to month 18
A participant is considered as achieved NEDA-3 if they were: * relapse-free, defined as no confirmed relapses in month 6 to 18. * 3-month clinical disability progression-free, defined as no clinical disability progression as measured by EDSS in month 6 to 18. * MRI activity-free, defined as 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 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.
16 secondary outcomes
Number of Confirmed MS Relapses in Months 6 to 18
Time frame: Month 6 to month 18
Participant Based Annualized Relapse Rate (ARR)
Time frame: Month 6 to month 18
Group Based Annualized Relapse Rate (ARR)
Time frame: Month 6 to month 18
Percentage of Participants That Were 3-month Disability Progression-free
Time frame: Month 6 to month 18
Percentage of Participants With NEDA (No Evidence of Disease Activity) - Clinical
Time frame: Month 6 to month 18
Number of Participants With NEDA (No Evidence of Disease Activity) - Radiological
Time frame: Month 6 to month 18
Change From Baseline in Gd+ Lesion Count
Time frame: Baseline to Month 18 and 30
Change From Baseline in Gd+ Lesion Volume
Time frame: Baseline to Month 18 and 30
Change From Baseline in New/Enlarging T2 Lesion Count
Time frame: Baseline to Month 18 and 30
Change From Baseline in T2 Lesion Volume
Time frame: Baseline to Month 18 and 30
Change From Baseline for NeuroQOL
Time frame: Baseline to Month 18 and 30
Change From Baseline for Patient Determined Disease Steps (PDDS)
Time frame: Baseline to Month 18 and 30
Brain Volume Loss (BVL) Assessment (Whole Brain and Regional)
Time frame: Month 6 to Month 18 and 30
Number of Participants With Treatment Emergent Adverse Events
Time frame: Baseline up to approximately Month 30
Change From Baseline in New Unenhancing T1 Lesion Number
Time frame: Baseline to Month 18 and 30
Change From Baseline in T1 Unenhancing Lesion Volume
Time frame: Baseline to Month 18 and 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
36 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ofatumumab in people with Relapse Remitting Multiple Sclerosis, run by Novartis Pharmaceuticals at 36 sites in 2 countries.
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 14 inclusion and 20 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: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Puerto Rico. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving NEDA-3 (No Evidence of Disease Activity-3) (time frame: Month 6 to month 18). 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 27 Feb 2026.