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Study of Infections in Patients With Autoimmune Diseases Treated With Rituximab (EXPRIME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03778840
Recruitment Status : Recruiting
First Posted : December 19, 2018
Last Update Posted : November 18, 2020
Sponsor:
Collaborator:
Grifols Biologicals, LLC
Information provided by (Responsible Party):
University Hospital, Lille

Study Description
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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
Autoimmune Diseases

Study Design
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Study Type : Observational
Estimated 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
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03778840


Contacts
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Contact: Vincent SOBANSKI, MD, PhD 3 20 44 42 95 ext +33 vincent.sobanski@chru-lille.fr

Locations
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France
Hôpital Claude Huriez, CHU Recruiting
Lille, France
Sponsors and Collaborators
University Hospital, Lille
Grifols Biologicals, LLC
Investigators
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Principal Investigator: Vincent SOBANSKI, MD, PhD University Hospital, Lille
More Information
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03778840    
Other Study ID Numbers: 2018_06
2018-A00188-47 ( Other Identifier: ID-RCB number, ANSM )
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Infections
immunoglobulins
secondary immunodeficiency
rituximab
Additional relevant MeSH terms:
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Infections
Autoimmune Diseases
Immune System Diseases