EXPRIME: Study of Infections in Patients With Autoimmune Diseases Treated With Rituximab

Sponsor

University Hospital, Lille (Other)

Overall Status

Recruiting

CT.gov ID

NCT03778840

Collaborator

Grifols Biologicals, LLC (Industry)

200

Enrollment

Location

35.1

Anticipated Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autoimmune Diseases

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

May 29, 2019

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

May 1, 2022

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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