B-cell Depletion in Offspring to Women With MS Under Immunomodulatory Treatment
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Rituximab
B-lymphocyte antigen CD20 binding agent
What it measured
Main measures
KREC and CD19 of B-cells in offspring to mothers with MS exposed to monoclonal anti-CD20 antibodies
2 years (2022-2023)
Immune responseAntibody production post vaccination in offspring to mothers with MS exposed to monoclonal anti-CD20 antibodies
4 years (2022-2025)
Immune responseFrequency and severity of infections in mothers with MS exposed to monoclonal anti-CD20 antibodies and their offspring
4 years (2022-2025)
Immune responseBlood levels of monoclonal anti-CD20 antibodies in offspring to mothers with MS exposed to monoclonal anti-CD20 antibodies before or during pregnancy
4 years (2022-2025)
Immune responseLevels of monoclonal anti-CD20 antibodies in breastmilk of breastfeeding mothers treated with monoclonal anti-CD20 antibodies in addition to measurement of anti-CD20 antibodies and evaluation of B-cells in blood from the breastfed child
4 years (2022-2025)
Immune response
Who could take part
MS (type not specified) · Up to 50
Inclusion Criteria: * Definite diagnosis of multiple sclerosis in mother AND * Administration of Rituximab, Ocrelizumab or Ofatumumab within 12 months or during established pregnancy OR * Administration of other immunomodulatory treatment within 12 months or during established pregnancy OR * No administration of immunomodulatory treatment within 12 months or during established pregnancy Exclusion Criteria: * Treatment with stem cell transfusion
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The overall aim of the study is to gain knowledge about consequences for the child´s humoral immunosystem in mothers with multiple sclerosis and due to their immunomodulating treatments. Of special interest is when the mother is treated with monoclonal CD20-antibody like rituximab, ocrelizumab and ofatumumab shortly before (within six months prior to conception) and during pregnancy. Specific aims of the study are to: * Investigate if the humoral immunosystem is fully functioning at birth in children born to mothers with MS * Investigate if the humoral immunosystem at birth in children born to mothers with MS is influenced by the mothers immunomodulating treatment * Investigate if monoclonal CD20-antibodies are fully eliminated in women treated with monoclonal CD20-antibodies within 12 months prior to conception. * Determine if children who have been exposed to monoclonal CD20-antibody in utero have reduced markers of successful B-cell production at birth. * Investigate the response to the Rota virus vaccine, a life-vaccine that is offered 6 weeks after birth to all children born after September 2019, in children to women treated with rituximab before or during pregnancy. * Investigate the response to other vaccines (DTP, Polio, HiB, pneumococcus given at 3 and 5 months after birth) the earliest one months after vaccination. * Investigate the occurrence of infections in the first-year post-partum for the mother and child due to hypogammaglobulinemia, b-cell depletion, and exposure to monoclonal CD20-antibody. * Investigate if oral exposure to rituximab through mother´s breastmilk is resulting in B-cell reduction in the child.
Papers
Background
Ahlgren C, Oden A, Lycke J. High nationwide incidence of multiple sclerosis in Sweden. PLoS One. 2014 Sep 29;9(9):e108599. doi: 10.1371/journal.pone.0108599. eCollection 2014.Background
Bove R, Alwan S, Friedman JM, Hellwig K, Houtchens M, Koren G, Lu E, McElrath TF, Smyth P, Tremlett H, Sadovnick AD. Management of multiple sclerosis during pregnancy and the reproductive years: a systematic review. Obstet Gynecol. 2014 Dec;124(6):1157-1168. doi: 10.1097/AOG.0000000000000541.Background
Langer-Gould AM. Pregnancy and Family Planning in Multiple Sclerosis. Continuum (Minneap Minn). 2019 Jun;25(3):773-792. doi: 10.1212/CON.0000000000000745.Background
Stern J, Salih Joelsson L, Tyden T, Berglund A, Ekstrand M, Hegaard H, Aarts C, Rosenblad A, Larsson M, Kristiansson P. Is pregnancy planning associated with background characteristics and pregnancy-planning behavior? Acta Obstet Gynecol Scand. 2016 Feb;95(2):182-9. doi: 10.1111/aogs.12816. Epub 2015 Dec 8.Background
Sedgh G, Singh S, Hussain R. Intended and unintended pregnancies worldwide in 2012 and recent trends. Stud Fam Plann. 2014 Sep;45(3):301-14. doi: 10.1111/j.1728-4465.2014.00393.x.Background
Bearak J, Popinchalk A, Alkema L, Sedgh G. Global, regional, and subregional trends in unintended pregnancy and its outcomes from 1990 to 2014: estimates from a Bayesian hierarchical model. Lancet Glob Health. 2018 Apr;6(4):e380-e389. doi: 10.1016/S2214-109X(18)30029-9. Epub 2018 Mar 5.Background
Salzer J, Svenningsson R, Alping P, Novakova L, Bjorck A, Fink K, Islam-Jakobsson P, Malmestrom C, Axelsson M, Vagberg M, Sundstrom P, Lycke J, Piehl F, Svenningsson A. Rituximab in multiple sclerosis: A retrospective observational study on safety and efficacy. Neurology. 2016 Nov 15;87(20):2074-2081. doi: 10.1212/WNL.0000000000003331. Epub 2016 Oct 19.Background
Klink DT, van Elburg RM, Schreurs MW, van Well GT. Rituximab administration in third trimester of pregnancy suppresses neonatal B-cell development. Clin Dev Immunol. 2008;2008:271363. doi: 10.1155/2008/271363.Background
Kumpfel T, Thiel S, Meinl I, Ciplea AI, Bayas A, Hoffmann F, Hofstadt-van Oy U, Hoshi M, Kluge J, Ringelstein M, Aktas O, Stoppe M, Walter A, Weber MS, Ayzenberg I, Hellwig K. Anti-CD20 therapies and pregnancy in neuroimmunologic disorders: A cohort study from Germany. Neurol Neuroimmunol Neuroinflamm. 2020 Dec 17;8(1):e913. doi: 10.1212/NXI.0000000000000913. Print 2021 Jan.Background
Smith JB, Hellwig K, Fink K, Lyell DJ, Piehl F, Langer-Gould A. Rituximab, MS, and pregnancy. Neurol Neuroimmunol Neuroinflamm. 2020 May 1;7(4):e734. doi: 10.1212/NXI.0000000000000734. Print 2020 Jul.
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History
Started
Jun 2025
Main results due
Dec 2025
Finished
Dec 2025
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