Rituximab-Induced Hypogammaglobulinemia in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04283747
• Other study ID #: 6217
• Status: Recruiting
• Start date: February 28, 2020
• Est. completion date: December 2022

Study information

• Verified date: July 2020
• Source: Mazandaran University of Medical Sciences
• Contact: Athena Sharifi Razavi
• Phone: 00989113510136
• Email: athena.sharifi[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: December 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Agammaglobulinemia
• Hypogammaglobulinemia
• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Bu Ali Sina hospital	Sari

Sponsors (1)

Lead Sponsor	Collaborator
Mazandaran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

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