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Completed

NCT Number: NCT03778840

Study of Infections in Patients With Autoimmune Diseases Treated With Rituximab

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.

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Key information

Conditions

Autoimmune Diseases Immune System Diseases Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Claude Huriez, CHU

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Occurrence of a serious infection event [SIE] in patient with an autoimmune disease treated with rituximab

    Time frame: 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 outcomes

  1. Hypogammaglobulinemia

    Time frame: Within 12 months after inclusion

    defined by immunoglobulin (Ig) G <6g / L.

  2. Replacement therapy with immunoglobulins

    Time frame: Within 12 months after inclusion

    Start of an immunoglobulins therapy to replace gammaglobulins

  3. Hypersensitivity skin reaction secondary to RTX injection.

    Time frame: Within 12 months after inclusion

    Attack rate of cutaneous hypersensitivity reactions after RTX injection in patients with dysimmune disease.

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Grifols Biologicals, LLC

Registry information

Official study 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

Acronym: EXPRIME

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Dec 19, 2018
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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