Study of Infections in Patients With Autoimmune Diseases Treated With Rituximab
NCT ID: NCT03778840
Last Updated: 2023-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
73 participants
OBSERVATIONAL
2019-05-29
2022-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Grifols Biologicals, LLC
INDUSTRY
University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Vincent SOBANSKI, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Lille
Locations
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Hôpital Claude Huriez, CHU
Lille, , France
Countries
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Other Identifiers
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2018-A00188-47
Identifier Type: OTHER
Identifier Source: secondary_id
2018_06
Identifier Type: -
Identifier Source: org_study_id
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