Rituximab-Induced Hypogammaglobulinemia in Multiple Sclerosis

NCT04283747 | Unknown DMC

• 1 other identifier: 6217
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Hypogammaglobulinemia

Keywords

Rituximab; Varicella Zoster; Hypogammaglobulinemia

Outcome Measures

Primary Outcomes (1)

• Rate of hypogammaglobinemia

  serum IgG concentration lower than g/L,

  every 6 month until 18 month

Secondary Outcomes (5)

• severity of hypogammaglobinemia

  every 6 month until 18 month

• immunization response to VZV vaccination

  every 6 month until 18 month

• Rate of infection

  during 18 month of fallow up

• type of infection

  During 18 month of study

• severity of infection events

  During 18 month of study

Interventions

Serum immunoglobulin titer DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Any adult patients with diagnosis of multiple sclerosis compatible with 2017 McDonald criteria and meet the inclusion and exclusion criteria from January 2020 until sample size will be reach, that refer to MS clinic of Bu Ali Sina Hospital, Sari,Iran.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mazandaran University of Medical Sciences: lead

Study Sites (1)

Bu Ali Sina hospital

Sari, Iran

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Agammaglobulinemia

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunologic Deficiency Syndromes

Study Officials

• monireh ghazaeian

  mazandaran university of medical science

  STUDY DIRECTOR

Central Study Contacts

Athena Sharifi Razavi

CONTACT

00989113510136; athena.sharifi@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Nerology

Study Record Dates

• First Submitted: February 22, 2020
• First Posted: February 25, 2020
• Study Start: February 28, 2020
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 10, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

IR (1)