Rituximab-Induced Hypogammaglobulinemia in Multiple Sclerosis

• Conditions: Multiple Sclerosis; Hypogammaglobulinemia

• Registration Number: NCT04283747
• Lead Sponsor: Mazandaran University of Medical Sciences

Brief 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.

Study Timeline

• Study First Submitted: 2020-02-22
• Study First Submitted QC: 2020-02-22
• Study First Posted: 2020-02-25
• Study Start: 2020-02-28
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-08
• Last Update Posted: 2020-07-10
• Primary Completion: 2022-10
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of hypogammaglobinemia	every 6 month until 18 month	serum IgG concentration lower than g/L,

Secondary Outcome Measures

Name	Time	Method
type of infection	During 18 month of study	infections in different organs
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
severity of infection events	During 18 month of study	need for hospitalization, oral or intravenous antibiotic therapy
Rate of infection	during 18 month of fallow up	number of all infection events

Trial Locations

Locations (1)

Bu Ali Sina hospital; 🇮🇷 Sari, Iran, Islamic Republic of