Effects of Ofatumumab Treatment on Immune Cells and Meningeal Lymphatic Drainage in Patients With Demyelinating Diseases
NCT ID: NCT05414487
Last Updated: 2022-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
34 participants
OBSERVATIONAL
2022-10-15
2024-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Ofatumumab
17 RMS patients and 17 NMOSD patients prescribed with Ofatumumab will be enrolled after informed consent.
Ofatumumab
There is no treatment allocation. Patients with MS or NMOSD administered Ofatumumab by prescription will be enrolled. Participants will receive 20mg ofatumumab (20 mg/0.4 ml) by subcutaneous injection. Ofatumumab is administrated at baseline, Day 7, Day 14 and monthly thereafter until the end of the study.
Interventions
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Ofatumumab
There is no treatment allocation. Patients with MS or NMOSD administered Ofatumumab by prescription will be enrolled. Participants will receive 20mg ofatumumab (20 mg/0.4 ml) by subcutaneous injection. Ofatumumab is administrated at baseline, Day 7, Day 14 and monthly thereafter until the end of the study.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
80 Years
ALL
No
Sponsors
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Tianjin Medical University General Hospital
OTHER
Responsible Party
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Chao Zhang
Professor
Principal Investigators
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Chao Zhang, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Neurology, Tianjin Medical University General Hospital
Locations
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Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Chao Zhang, M.D., Ph.D.
Role: primary
Yi Shen, M.D., Ph.D.
Role: backup
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Ding XB, Wang XX, Xia DH, Liu H, Tian HY, Fu Y, Chen YK, Qin C, Wang JQ, Xiang Z, Zhang ZX, Cao QC, Wang W, Li JY, Wu E, Tang BS, Ma MM, Teng JF, Wang XJ. Impaired meningeal lymphatic drainage in patients with idiopathic Parkinson's disease. Nat Med. 2021 Mar;27(3):411-418. doi: 10.1038/s41591-020-01198-1. Epub 2021 Jan 18.
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.
Other Identifiers
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COMB157GCN02T
Identifier Type: -
Identifier Source: org_study_id
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