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Clinical Trials/NCT07343089
NCT07343089RecruitingNot Applicable

A Multicenter Real-life Study of Disseminated Borreliosis Cases Occurring in Patients Receiving Anti-CD20 Treatment in France

University Hospital, Strasbourg, France1 site in 1 country100 target enrollmentStarted: August 29, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Description of the clinical presentation of cases of disseminated borreliosis occurring in patients receiving anti-CD20 therapy in France

Study Overview

Brief Summary

Clinical, biological, radiological, and pharmacological description of cases of disseminated borreliosis (Borrelia burgdorferi sl. and Borrelia miyamotoi) occurring in patients who received drug treatment based on anti-CD20 monoclonal antibodies.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Retrospective

Eligibility Criteria

Ages
1 Year to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Minor or adult subject
  • Having presented disseminated borreliosis confirmed by molecular biology (Borrelia burgdorferi sl. or Borrelia miyamotoi) within 24 months of receiving treatment with an anti-CD20 monoclonal antibody between January 1, 2010, and July 30, 2025.

Exclusion Criteria

  • - Refusal to participate in the study

Outcomes

Primary Outcomes

Description of the clinical presentation of cases of disseminated borreliosis occurring in patients receiving anti-CD20 therapy in France

Time Frame: Up to 12 months

The clinical presentation describes how the disease manifests in patients: * the symptoms, * their severity, * and their progression. Example: Two patients may have the same disease, but one will primarily experience fever while the other will have neurological symptoms. This is part of the clinical presentation.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University Hospital, Strasbourg, France
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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