NCT04283747

Rituximab-Induced Hypogammaglobulinemia in Multiple Sclerosis

Hypogammaglobulinemia and Immunization Responses to Measles in Rituximab-treated Multiple Sclerosis Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 170 (estimated)
• Sponsor: Mazandaran University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Multiple Sclerosis
• Hypogammaglobulinemia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Serum immunoglobulin titer	Serum IgG and IgM levels, VZV titer every 6 month at before rituximab administration 3 times

Timeline

• Start date: 2020-02-28
• Primary completion: 2022-10-01
• Completion: 2022-12-01
• First posted: 2020-02-25
• Last updated: 2020-07-10

Locations

1 site across 1 country: Iran