Multiple Sclerosis Clinical Trial
Official title:
Hypogammaglobulinemia and Immunization Responses to Measles in Rituximab-treated Multiple Sclerosis Patients
B cells are considered major contributors to multiple sclerosis (MS) pathogenesis, a role
that has taken on renewed importance with the advent of B-cell-depleting therapies. Rituximab
is being increasingly utilized as an off-label treatment option across MS patients .
In addition, there have been increasing reports of rituximab causing hypogammaglobulinaemia
and antibody deficiency across a variety of conditions including MS and related
neuroinflammatory disorders.
Therefore, the purpose of this study is to evaluate the rate of hypogammaglobulinemia in
rituximab-treated MS adult patients and to assess the correlation with vaccination response
during the treatment.
This is a prospective study which will be conducted in an educational medical hospitals in Sari, Iran.Adult patients with diagnosis of multiple sclerosis compatible with 2017 McDonald criteria and history of treatment with rituximab at least 3 times( 18 month) , enrolled to this study.Demographic patients' characteristics, including age, sex, vital sign, past medical history, drug history, will be recorded. Disease duration prior to rituximab, total rituximab dose, prior immunomodulatory drugs, Adverse drug reactions, the time interval between the last rituximab infusion and need for intravenous immunoglobulin replacement therapy and infections are recorded. Moreover, we will assess IgG and IgM levels, VZV titer at before rituximab administration and 6, 12, 18, months following the initiation of next dose of rituximab. ;
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