Status:

COMPLETED

Study of Infections in Patients With Autoimmune Diseases Treated With Rituximab

Lead Sponsor:

University Hospital, Lille

Collaborating Sponsors:

Grifols Biologicals, LLC

Conditions:

Autoimmune Diseases

Eligibility:

All Genders

18+ years

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

May 29 2019

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

May 31 2022

Estimated Enrollment :

73 Patients enrolled

Trial Details

Trial ID

NCT03778840

Start Date

May 29 2019

End Date

May 31 2022

Last Update

February 6 2023

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Hôpital Claude Huriez, CHU

Lille, France