Study of Infections in Patients With Autoimmune Diseases Treated With Rituximab

Completed

• Conditions: Autoimmune Diseases

• Registration Number: NCT03778840
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-18
• Study First Submitted QC: 2018-12-17
• Study First Posted: 2018-12-19
• Study Start: 2019-05-29
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-02-03
• Last Update Posted: 2023-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hôpital Claude Huriez, CHU; 🇫🇷 Lille, France