Study of Infections in Patients With Autoimmune Diseases Treated With Rituximab

NCT03778840 | Completed

• 2 other identifiers: 2018_062018-A00188-47
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune Diseases

Keywords

Infections; immunoglobulins; secondary immunodeficiency; rituximab

Outcome Measures

Primary Outcomes (1)

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

  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

  Within 12 months after inclusion

Secondary Outcomes (3)

• Hypogammaglobulinemia

  Within 12 months after inclusion

• Replacement therapy with immunoglobulins

  Within 12 months after inclusion

• Hypersensitivity skin reaction secondary to RTX injection.

  Within 12 months after inclusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead
• Grifols Biologicals, LLC: collaborator

Study Sites (1)

Hôpital Claude Huriez, CHU

Lille, France

Location

MeSH Terms

Conditions

Autoimmune Diseases; Infections

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Vincent SOBANSKI, MD, PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: December 19, 2018
• Study Start: May 29, 2019
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: February 6, 2023

Record last verified: 2023-01

Locations

FR (1)