Rituximab-Induced Hypogammaglobulinemia in Multiple Sclerosis

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-28

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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

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Multiple Sclerosis Hypogammaglobulinemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Serum immunoglobulin titer

Serum IgG and IgM levels, VZV titer every 6 month at before rituximab administration 3 times

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. diagnosis of multiple sclerosis compatible with 2017 McDonald criteria
2. history of treatment with ritximab at least for 18 month
3. written informed consent

Exclusion Criteria

1. history of IVIG intake in 3 past month
2. history of plasmapheresis in 3 past month
3. unknown vaccination history
4. any indication for concurrent use of immunomodulator or immunosuppressor drug

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No