Study of Infections in Patients With Autoimmune Diseases Treated With Rituximab

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03778840

Acronym

EXPRIME

Enrollment

Registered

2018-12-19

Start date

2019-05-29

Completion date

2022-05-31

Last updated

2026-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Diseases

Keywords

Infections, immunoglobulins, secondary immunodeficiency, rituximab

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Occurrence of a serious infection event [SIE] in patient with an autoimmune disease treated with rituximab	Within 12 months after inclusion	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

Secondary

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

Countries

France

Contacts

PRINCIPAL_INVESTIGATORVincent SOBANSKI, MD, PhD

University Hospital, Lille

Outcome results