Study of Infections in Patients With Autoimmune Diseases Treated With Rituximab

Autoimmune Diseases Clinical Trial

— EXPRIME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03778840
• Other study ID #: 2018_06
• Secondary ID: 2018-A00188-47
• Status: Completed
• Start date: May 29, 2019
• Est. completion date: May 31, 2022

Study information

• Verified date: January 2023
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases
• Infections

Locations

Country	Name	City	State
France	Hôpital Claude Huriez, CHU	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Grifols Biologicals, LLC

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hypogammaglobulinemia	defined by immunoglobulin (Ig) G <6g / L.	Within 12 months after inclusion
Secondary	Replacement therapy with immunoglobulins	Start of an immunoglobulins therapy to replace gammaglobulins	Within 12 months after inclusion
Secondary	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