Systemic Lupus Erythematosus With or Without Clinical ActivityNCT01889654
Anti-nucleosome B Lymphocytes in Lupus
An observational study of Systemic Lupus Erythematosus With or Without Clinical Activity, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Lupus disease is characterized by the production of pathogenic autoantibodies, which participate in end-organ damages. The phenotype of B cells producing the pathogenic autoantibodies in lupus patients is today unknown. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus With or Without Clinical Activity
- What is being tested?
- Venous blood sampling
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: lupus patient and healthy volunteers
Who may be able to join
- SLE patient : diagnostic based on ACR criteria
- SLE patient producing seric anti-nucleosome antibodies (ELISA)
- SLEDAI-2K activity score : inferior to 5 for quiescent patients, superior to 8 since at least 2 months for active patients
Who cannot join
- -- Other autoimmune diseases than SLE- Induced lupus
- Treatment with corticosteroids >10mg/d (prednisone) for quiescent patients
- Treatment with corticosteroids >20mg/d (prednisone) for active patients
- Oral immunosuppressive treatment during the last 6 months (methotrexate, azathioprine, ciclosporine, mycophénolate mofétil) for all patients, treatment during the last year with cyclophosphamide or monoclonal antibodies (rituximab, belimumab) for pour quiescent patients
- Disease which can modify B and T lymphocyte functions: primary immune deficiencies, evolutive infections, chronic viral infection (VIH in particular), chemotherapy or neoplasm antecedent
Trial locations and contacts
1 site in 1 country.
France1 site
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, Bas Rhin, 67091
About this study
Official title: Analysis of Frequency and Phenotype of Anti-nucleosome B Lymphocyte in Systemic Lupus
Lupus disease is characterized by the production of pathogenic autoantibodies, which participate in end-organ damages. The phenotype of B cells producing the pathogenic autoantibodies in lupus patients is today unknown. Antinucleosome antibodies are characteristic of lupus disease.This project proposes to detect antinucleosome B cells in lupus patients and to analyse their phenotype and their frequency.
- Being tested
- Venous blood sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous blood samplingOther
| Study group | Role | What they receive |
|---|---|---|
| patient | Not described Receives: Other: Venous blood sampling | |
| healthy volunteers | Not described Receives: Other: Venous blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study startFeb 2014
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: recrutment difficulty
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erythematosus With or Without Clinical ActivityStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
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
- NCT01889654
- Sponsor's protocol ID
- 5543
- Status last verified
- Jan 2017
- First submitted
- 25 Jun 2013
- Last updated
- 11 Sep 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Frequency and Phenotype of Anti-nucleosome B Lymphocyte in Systemic Lupus
- ClinicalTrials.gov ID
- NCT01889654
- Acronym / sponsor ID
- 5543
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: recrutment difficulty
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 28 Jun 2013 (estimated)
- 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.
Lupus disease is characterized by the production of pathogenic autoantibodies, which participate in end-organ damages. The phenotype of B cells producing the pathogenic autoantibodies in lupus patients is today unknown. Antinucleosome antibodies are characteristic of lupus disease.This project proposes to detect antinucleosome B cells in lupus patients and to analyse their phenotype and their frequency.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient | – | Other: Venous blood sampling |
| healthy volunteers | – | Other: Venous blood sampling |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- lupus patient and healthy volunteers
Key inclusion criteria (3 listed)
- SLE patient : diagnostic based on ACR criteria
- SLE patient producing seric anti-nucleosome antibodies (ELISA)
- SLEDAI-2K activity score : inferior to 5 for quiescent patients, superior to 8 since at least 2 months for active patients
Key exclusion criteria (5 listed)
- -- Other autoimmune diseases than SLE- Induced lupus
- Treatment with corticosteroids >10mg/d (prednisone) for quiescent patients
- Treatment with corticosteroids >20mg/d (prednisone) for active patients
- Oral immunosuppressive treatment during the last 6 months (methotrexate, azathioprine, ciclosporine, mycophénolate mofétil) for all patients, treatment during the last year with cyclophosphamide or monoclonal antibodies (rituximab, belimumab) for pour quiescent patients
- Disease which can modify B and T lymphocyte functions: primary immune deficiencies, evolutive infections, chronic viral infection (VIH in particular), chemotherapy or neoplasm antecedent
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 |
|---|---|---|
| Venous blood sampling | Other | healthy volunteers, patient |
Primary outcome
all cause mortality
Time frame: 1 year
Results and safety
The study was stopped early (reason given: recrutment difficulty). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Systemic Lupus Erythematosus With or Without Clinical Activity, 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 11 Sep 2017. 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?
The study was stopped early (reason given: recrutment difficulty). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (time frame: 1 year). 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 11 Sep 2017.