Rituximab-Induced Hypogammaglobulinemia in Multiple Sclerosis

NCT04283747 — Unknown, 170 participants, Mazandaran University of Medical Sciences

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

Registry	NCT04283747
Status	Unknown
Study type	Observational
Enrollment	170 (Estimated)
Sponsor	Mazandaran University of Medical Sciences (Other)
Conditions	Multiple Sclerosis, Hypogammaglobulinemia
Interventions	Serum immunoglobulin titer (Diagnostic test)
Dates	start 2020-02-28, primary completion 2022-10-01 (estimated), completion 2022-12-01 (estimated), first posted 2020-02-25, last updated 2020-07-10
Locations	1 site in Iran

-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.

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+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.

+Arms and interventions

Serum immunoglobulin titer (Diagnostic test): Serum IgG and IgM levels, VZV titer every 6 month at before rituximab administration 3 times

+Outcome measures

Primary outcomes

Rate of hypogammaglobinemia [every 6 month until 18 month]: serum IgG concentration lower than g/L,

Secondary outcomes

severity of hypogammaglobinemia [every 6 month until 18 month]: serum IgG concentration: mild (at risk) 5- 6.9 g/L, moderate 3- 4.9 g/L and severe < 3 g/L
immunization response to VZV vaccination [every 6 month until 18 month]: change of VZV antibody titre
Rate of infection [during 18 month of fallow up]: number of all infection events
type of infection [During 18 month of study]: infections in different organs
severity of infection events [During 18 month of study]: need for hospitalization, oral or intravenous antibiotic therapy

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Bu Ali Sina hospital	Sari	Iran	Recruiting

+Investigators

monireh ghazaeian, Study director, mazandaran university of medical science