OMNISCIENCE
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Ofatumumab
B-lymphocyte antigen CD20 binding agent
What it measured
Main measures
Change from baseline in Time to Peak (TTP) of the meningeal lymphatic vessels in superior sagittal sinus (mLVs-SSS) to the end of study.
Baseline, Up To 12months (End of Study)
MRI lesions
Other measures (4)
Immune cells landscape over time
Baseline, month 3, month 6, month 12
Immune responseAdjudicated On-trial Annualized Relapse Rate (ARR)
Baseline, Up To 12months (End of Study)
RelapsesPercentage of Participants With Worsening in Expanded Disability Severity Scale (EDSS) Score From Baseline to the end of study
Baseline, Up To 12months (End of Study)
Disability progressionPercentage of participants with new lesions by MRI assessments from baseline to the end of study
Baseline, Up To 12months (End of Study)
MRI lesionsQuality of life (reported by participants)
Who could take part
Relapsing MS · 18 to 80
Inclusion Criteria: 1. Signed informed consent 2. RRMS subtype according to 2017 McDonald diagnostic criteria 3. Diagnosis of NMOSD according to the 2015 International Panel diagnostic criteria for NMOSD with AQP4-IgG 4. Newly diagnosed with MS/NMOSD and initiating ofatumumab treatment within the next 3 months Exclusion Criteria: 1. Hypersensitivity to trial medications 2. History of life-threatening reaction to Ofatumumab 3. Acute or uncontrolled chronic medical condition 4. Have been treated with medications as specified or within timeframes specified (e.g. corticosteroids, rituximab, ocrelizumab, alemtuzumab, natalizumab, cyclophosphamide, claridbine, etc.) 5. Impaired hearing 6. Claustrophobia 7. 300 lbs of greater (weight limit of MRI table) 8. Pregnancy or breastfeeding 9. Sensitivity to imaging agents 10. Contraindications to MRI 11. Use of benzodiazepines, topiramate, doxycycline, mynocicline
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This is an uncontrolled, prospective, observational cohort study to assess the function of meningeal lymphatic drainage and dynamics of immune cells in patients with relapsing multiple sclerosis (RMS) or Neuromyelitis optica spectrum disorder (NMOSD) after receiving ofatumumab treatment over an observational period of 12 months.
Papers
Results
Yang S, Zhang TX, Liu J, Liu Z, Zhu L, Li YY, Feng B, Fan M, Shi FD, Zhang C. Reconstitution of CXCR3+ CCR6+ Th17.1-Like T Cells in Response to Ofatumumab Therapy in Patients With Multiple Sclerosis. Ann Clin Transl Neurol. 2025 May;12(5):1043-1053. doi: 10.1002/acn3.70042. Epub 2025 Mar 31.Background
Bar-Or A, Li R. Cellular immunology of relapsing multiple sclerosis: interactions, checks, and balances. Lancet Neurol. 2021 Jun;20(6):470-483. doi: 10.1016/S1474-4422(21)00063-6. Epub 2021 Apr 27.Background
Couloume L, Ferrant J, Le Gallou S, Mandon M, Jean R, Bescher N, Zephir H, Edan G, Thouvenot E, Ruet A, Debouverie M, Tarte K, Ame P, Roussel M, Michel L. Mass Cytometry Identifies Expansion of T-bet+ B Cells and CD206+ Monocytes in Early Multiple Sclerosis. Front Immunol. 2021 May 4;12:653577. doi: 10.3389/fimmu.2021.653577. eCollection 2021.Background
Hershenhouse KS, Shauly O, Gould DJ, Patel KM. Meningeal Lymphatics: A Review and Future Directions From a Clinical Perspective. Neurosci Insights. 2019 Dec 31;14:1179069519889027. doi: 10.1177/1179069519889027. eCollection 2019.Background
Migotto MA, Mardon K, Orian J, Weckbecker G, Kneuer R, Bhalla R, Reutens DC. Efficient Distribution of a Novel Zirconium-89 Labeled Anti-cd20 Antibody Following Subcutaneous and Intravenous Administration in Control and Experimental Autoimmune Encephalomyelitis-Variant Mice. Front Immunol. 2019 Oct 18;10:2437. doi: 10.3389/fimmu.2019.02437. eCollection 2019.Background
Louveau A, Herz J, Alme MN, Salvador AF, Dong MQ, Viar KE, Herod SG, Knopp J, Setliff JC, Lupi AL, Da Mesquita S, Frost EL, Gaultier A, Harris TH, Cao R, Hu S, Lukens JR, Smirnov I, Overall CC, Oliver G, Kipnis J. CNS lymphatic drainage and neuroinflammation are regulated by meningeal lymphatic vasculature. Nat Neurosci. 2018 Oct;21(10):1380-1391. doi: 10.1038/s41593-018-0227-9. Epub 2018 Sep 17.Background
Wang X, Tian H, Liu H, Liang D, Qin C, Zhu Q, Meng L, Fu Y, Xu S, Zhai Y, Ding X, Wang X. Impaired Meningeal Lymphatic Flow in NMOSD Patients With Acute Attack. Front Immunol. 2021 Jun 14;12:692051. doi: 10.3389/fimmu.2021.692051. eCollection 2021.Background
Zhang C, Zhang TX, Liu Y, Jia D, Zeng P, Du C, Yuan M, Liu Q, Wang Y, Shi FD. B-Cell Compartmental Features and Molecular Basis for Therapy in Autoimmune Disease. Neurol Neuroimmunol Neuroinflamm. 2021 Aug 31;8(6):e1070. doi: 10.1212/NXI.0000000000001070. Print 2021 Nov.Background
Leipold MD, Maecker HT. Mass cytometry: protocol for daily tuning and running cell samples on a CyTOF mass cytometer. J Vis Exp. 2012 Nov 2;(69):e4398. doi: 10.3791/4398.Background
Thrash EM, Kleinsteuber K, Hathaway ES, Nazzaro M, Haas E, Hodi FS, Severgnini M. High-Throughput Mass Cytometry Staining for Immunophenotyping Clinical Samples. STAR Protoc. 2020 Jun 30;1(2):100055. doi: 10.1016/j.xpro.2020.100055. eCollection 2020 Sep 18.
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History
Started
Oct 2022
Main results due
Dec 2023
Finished
Jun 2024
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