Systemic Lupus ErythematosusCO LUPUSNCT04320680
Systemic Lupus Erythematosus Within the Framework of the Multidisciplinary Consultation
A study testing description of a lupus patient cohort in people with Systemic Lupus Erythematosus, run by University Hospital, Brest at 1 site in France.
Trial summary
Diagnosis and follow up of a lupus cohort in a multidisciplinary consultation in Brest ( France) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- description of a lupus patient cohort
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 13 Oct 2020to 13 May 2025
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women or men, more than 18 years old, coming to the multidisciplinary consultation in brest ( France).
- With written consentment
Who cannot join
- patients less than 18 years old
- refusing to participate
- Under legal protection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Cohort Follow-up of Systemic Lupus Erythematosus Within the Framework of the Multidisciplinary Consultation at the CHRU of Brest
Diagnosis and follow up of a lupus cohort in a multidisciplinary consultation in Brest ( France)
Read the detailed description
all patients coming to the LUPUS multidisciplinary consultation in brest ( France) will have a clinical examination, a biological and immunogical blood samples, cutaneous biopsies or renal biospies if necessary, an ultrasonographic articular and salivary glandular examination if needed. In case of articular involvement, some Xrays ( hands and feet) will be done at the inclusion and during the follow up each year during 5 years .
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- description of a lupus patient cohort
- Keywords
- cutaneous lupus
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
description of a lupus patient cohortOther
description of a lupus patient cohort
| Study group | Role | What they receive |
|---|---|---|
| lupus cohort follow up | Other | it is a descrption lupus patients study Receives: Other: description of a lupus patient cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort lupus: epidemiologic lupus study about diagnosis and follow up
epidemiologic lupus study in collecting data ( description of the population, biologic and immunologic data collection, data of articular damges with xrays datas) about Diagnosis and follow up of a cohort lupus in a multidisciplibnary consultation in brest hospital ( France).
Measured: five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start13 Oct 2020
- Primary completion13 May 2025 (estimated)
- Study completion13 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- diagnosis and follow up of a lupus cohort
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320680
- Sponsor's protocol ID
- 29BRC20.0073
- Acronym
- CO LUPUS
- Status last verified
- Feb 2025
- First submitted
- 23 Mar 2020
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Follow-up of Systemic Lupus Erythematosus Within the Framework of the Multidisciplinary Consultation at the CHRU of Brest
- ClinicalTrials.gov ID
- NCT04320680
- Acronym / sponsor ID
- CO LUPUS / 29BRC20.0073
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- cutaneous lupus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 13 May 2025 (estimated)
- Study completion
- 13 May 2025 (estimated)
- First posted
- 25 Mar 2020 (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.
Diagnosis and follow up of a lupus cohort in a multidisciplinary consultation in Brest ( France)
Detailed description
all patients coming to the LUPUS multidisciplinary consultation in brest ( France) will have a clinical examination, a biological and immunogical blood samples, cutaneous biopsies or renal biospies if necessary, an ultrasonographic articular and salivary glandular examination if needed. In case of articular involvement, some Xrays ( hands and feet) will be done at the inclusion and during the follow up each year during 5 years .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- diagnosis and follow up of a lupus cohort
| Arm | Type | Receives |
|---|---|---|
| lupus cohort follow up | Other | Other: description of a lupus patient cohortit is a descrption lupus patients study |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- women or men, more than 18 years old, coming to the multidisciplinary consultation in brest ( France).
- With written consentment
Key exclusion criteria (3 listed)
- patients less than 18 years old
- refusing to participate
- Under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| description of a lupus patient cohortdescription of a lupus patient cohort | Other | lupus cohort follow up |
Primary outcome
Cohort lupus: epidemiologic lupus study about diagnosis and follow up
Time frame: five years
epidemiologic lupus study in collecting data ( description of the population, biologic and immunologic data collection, data of articular damges with xrays datas) about Diagnosis and follow up of a cohort lupus in a multidisciplibnary consultation in brest hospital ( France).
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 4 Feb 2025.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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?
A study testing description of a lupus patient cohort in people with Systemic Lupus Erythematosus, run by University Hospital, Brest 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 3 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 4 Feb 2025. 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 sandrine jousse joulin, MD (+33 2 98 34 72 68, sandrine.jousse-oulin@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort lupus: epidemiologic lupus study about diagnosis and follow up (time frame: five years). 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 4 Feb 2025.