Study of Infections in Patients With Autoimmune Diseases Treated With Rituximab (EXPRIME)

Prospective Study of Incidence and Risk Factors of Infections and of Replacement Therapy With Intravenous Immunoglobulins for Secondary Immunodeficiency in Patients With Autoimmune Diseases Treated With Rituximab

Rituximab is a very effective drug used to treat many inflammatory diseases. These diseases include, for example, rheumatoid arthritis, multiple sclerosis and systemic autoimmune diseases.

The major drawback of this drug is the risk of infection, which are favored by the direct effect of rituximab on the immune system. The risk of infection is one of the major reason not to prescribe or withdraw rituximab in several patients. However, many questions remain unanswered regarding the proportion and risk factors of infection or immunodeficiency induced by rituximab. Better understanding of these issues will help prescribing rituximab and properly monitor patients during their treatment. Moreover, as treatment with substitutive immunoglobulins might be a solution to decrease the risk of infections in those patients, it is very important to better characterize the risk and risk factors of rituximab-associated infection. The present study aims to answer these questions.

Study Overview

• Status: Completed
• Conditions: Autoimmune Diseases

• Study Type: Observational
• Enrollment (Actual): 73

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Hôpital Claude Huriez, CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The patients included in the study will be the patients beginning a cure of RTX prescribed within the framework of the treatment of their inflammatory disease or dysimmunitaire chronic.

Description

Inclusion Criteria:

• Patient initiating treatment with RTX, delivered by the central pharmacy of Lille University Hospital
• Inpatient or outpatient at Lille University Hospital (in one of the following departments: internal medicine, rheumatology, neurology, dermatology, pneumology) and monitored every three months as part of routine care (as part of the surveillance of induction of RTX treatment)
• Patient with one of the following autoimmune diseases, defined by international criteria

Exclusion Criteria:

• Treatment with rituximab for a malignancy or a transplant reject
• Pregnant or lactating women
• People in emergency
• Administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of coverage by the social security system, refusal to sign consent
• Persons deprived of their liberty
• People unable to consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of a serious infection event [SIE] in patient with an autoimmune disease treated with rituximab	A serious infection event [SIE] defined as any infection which led to hospitalization and/or death and/or required treatment with intravenous antibiotic/antiviral drugs	Within 12 months after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypogammaglobulinemia	defined by immunoglobulin (Ig) G <6g / L.	Within 12 months after inclusion
Replacement therapy with immunoglobulins	Start of an immunoglobulins therapy to replace gammaglobulins	Within 12 months after inclusion
Hypersensitivity skin reaction secondary to RTX injection.	Attack rate of cutaneous hypersensitivity reactions after RTX injection in patients with dysimmune disease.	Within 12 months after inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Grifols Biologicals, LLC
• Investigators: Principal Investigator: Vincent SOBANSKI, MD, PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 29, 2019
• Primary Completion (ACTUAL): May 31, 2022
• Study Completion (ACTUAL): May 31, 2022

Study Registration Dates

• First Submitted: September 18, 2018
• First Submitted That Met QC Criteria: December 17, 2018
• First Posted (ACTUAL): December 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: rituximab; Infections; immunoglobulins; secondary immunodeficiency
• Additional Relevant MeSH Terms: Immune System Diseases; Infections; Autoimmune Diseases
• Other Study ID Numbers: 2018_06; 2018-A00188-47 (OTHER: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No