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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04283747
Other study ID # 6217
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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