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NCT Number: NCT07343089

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

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.

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Key information

Conditions

Borrelia Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Lyme Disease Spirochaetales Infections Tick-Borne Diseases Vector Borne Diseases

Age range

1 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Laboratoire de Bactériologie - CHU de Strasbourg - France

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Pierre BOYER, MD

CONTACT

[email protected]

33 3 69 55 14 69

Pierre BOYER, MD

PRINCIPAL_INVESTIGATOR

Émilie TALAGRAND-REBOUL

PRINCIPAL_INVESTIGATOR

Émilie TALAGRAND-REBOUL, MD

CONTACT

[email protected]

33 3 69 55 14 57

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pierre BOYER, MD

CONTACT

[email protected]

33 3 69 55 14 69

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: BorDiMab

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jan 15, 2026
Registry last updated: Jan 15, 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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Recruiting