Borrelia InfectionsBorDiMabNCT07343089
A Multicenter Real-life Study of Disseminated Borreliosis Cases Occurring in Patients Receiving Anti-CD20 Treatment in France
An observational study of Borrelia Infections, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Borrelia Infections
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 29 Aug 2025to 29 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient 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.
Who may be able to join
- 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.
Who cannot join
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Laboratoire de Bactériologie - CHU de Strasbourg - France
Strasbourg, 67091
Pierre BOYER, MD, 33 3 69 55 14 69, pierre.boyer@chru-strasbourg.fr
Émilie TALAGRAND-REBOUL, MD, 33 3 69 55 14 57, Emilie.TALAGRANDREBOUL@chru-strasbourg.fr
About this study
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.
- Conditions
- Borrelia Infections
- Keywords
- Borreliosis, Lyme, Borrelia Infections, Borrelia Burgdorferi, Borrelia Miyamotoi, Anti-CD20 monoclonal antibodies
- Medical subject headings
- Borrelia Infections, Lyme Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the clinical presentation of cases of disseminated borreliosis occurring in patients receiving anti-CD20 therapy in France
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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start29 Aug 2025
- Primary completionAug 2026 (estimated)
- Study completion29 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borrelia InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343089
- Sponsor's protocol ID
- 9819
- Acronym
- BorDiMab
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Real-life Study of Disseminated Borreliosis Cases Occurring in Patients Receiving Anti-CD20 Treatment in France
- ClinicalTrials.gov ID
- NCT07343089
- Acronym / sponsor ID
- BorDiMab / 9819
- Conditions
- Borrelia Infections
- Keywords
- Borreliosis, Lyme, Borrelia Infections, Borrelia Burgdorferi, Borrelia Miyamotoi, Anti-CD20 monoclonal antibodies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 29 Aug 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- 29 Aug 2026 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Borrelia Infections, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre BOYER, MD (33 3 69 55 14 69, pierre.boyer@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026; AzTrials last refreshed its copy on 26 Oct 2026.