Clinical trial NCT03778840: Study of Infections in Patients With Autoimmune Diseases Treated With Rituximab
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autoimmune Diseases
Keywords: Infections
immunoglobulins
secondary immunodeficiency
rituximab
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Grifols Biologicals, LLC
First posted: 2018-12-19
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of a serious infection event [SIE] in patient with an autoimmune disease treated with rituximab
timeFrame: Within 12 months after inclusion
Secondary outcomes:
measure: Hypogammaglobulinemia
timeFrame: Within 12 months after inclusion
measure: Replacement therapy with immunoglobulins
timeFrame: Within 12 months after inclusion
measure: Hypersensitivity skin reaction secondary to RTX injection.
timeFrame: Within 12 months after inclusion
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Claude Huriez, CHU
Study officials:
affiliation: University Hospital, Lille
name: Vincent SOBANSKI, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: