SOSTOS
What it found
No result yet.
What was tested
Treatment tested
- Ofatumumab
B-lymphocyte antigen CD20 binding agent
Compared with
- Disease modifying treatment (DMT)
What it measured
Main measures
Percentage of participants achieving NEDA-3 (No Evidence of Disease Activity-3)
Months 3 to 15
RelapsesMRI lesions
Other measures (16)
Percentage of participants with a single baseline NfL≥10pg/ml and NfL<10pg/ml achieving NEDA-3 (No Evidence of Disease Activity-3)
Months 3 to15
RelapsesMRI lesionsBlood or spinal fluid markersAnnualized relapse rate in Months 3 to 15
Months 3 to 15
Disability progressionRelapsesFatigueBladder, bowel and sexual functionPercentage of participants without a worsening of their disability
Months 3 to 15
Percentage of participants with NEDA (No Evidence of Disease Activity) - Clinical
Months 3 to 15
Disability progressionRelapsesPercentage of participants with NEDA (No Evidence of Disease Activity) - Radiological
Months 3 to 15
MRI lesionsMean change in The Symbol-Digit Modality Test
Baseline, Months 3 and 15
Thinking and memoryMean change in the Time 25 Foot Walk
Baseline, Months 3 and 15
Walking and mobilityMean change in the 9 Hole Peg Test
Baseline, Months 3 and 15
Disability progressionArm and hand functionMean change in Gd+ lesion count
Baseline, Months 3 and 15
MRI lesionsMean change in Gd+ lesion volume
Baseline, Months 3 and 15
MRI lesions
Who could take part
Relapsing and progressive · 18 to 50
Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study. * Age 18-45 years * Diagnosis of RRMS per McDonald Criteria (2017) * EDSS 0-5.5 (Inclusive) * Able to obtain MRI and attend study visits at sites * Willing to use wearable device as specified in the protocol * Able to provide blood sample * On a current DMT with approved label use for treatment of RRMS at least 6 months prior to Screening * No relapse reported within 6 months prior to Screening * Patients may enroll in the trial if they have subclinical disease activity as measured by MRI prior to enrollment. An absence of MRI activity is not exclusionary. Exclusion Criteria: * Primary progressive or secondary progressive phenotype * Diseases other than multiple sclerosis responsible for the clinical or MRI presentation * Use of experimental or investigational drugs for MS within 2 years from Screening * Known sensitivity to gadolinium * Central Nervous System (CNS) anomalies that are better accounted for by another disease process * Known active malignancies * Active chronic disease (or stable but treated with immune therapy) of the immune system other than MS * Active infections including systemic bacterial, viral (including COVID-19) or fungal infections, known to have AIDS or tested positive for HIV antibodies * Neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML), or confirmed PML * IgG or IgM levels below lower limit of normal (LLN) at Screening
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This study will evaluate if relapsing-remitting MS patients that have not had a relapse in the past year would benefit from a switch to ofatumumab versus staying on their continued current therapy. This study will also look at whether an elevated serum neurofilament light (NfL) level predicts enhanced benefit from a switch to ofatumumab.
Papers
Loading reviews and guidelines…
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History
Started
Mar 2022
Main results due
Apr 2027
Finished
Apr 2027
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