Systemic Autoimmune DiseaseLIMANCT04749875
Study of Leukocyte Populations in Patients With Chronic Inflammatory
An observational study of Systemic Autoimmune Disease and Chronic Inflammatory Rheumatism, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Exploration of pathophysiological mechanisms in chronic inflammatory rheumatism and rare systemic autoimmune diseases with the objective of identifying therapeutic targets. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Autoimmune Disease, Chronic Inflammatory Rheumatism, Sjogren's Syndrome
- What is being tested?
- blood sample
- How many people
- 1,500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2021to 1 Mar 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with chronic inflammatory rheumatism and rare systemic autoimmune diseases
Who may be able to join
- Age ≥18 years
- Patient who did not express his opposition
- Patients with chronic inflammatory rheumatism and rare systemic autoimmune diseases (pSS, lupus, scleroderma, myositis, unclassified connectivitis) diagnosed according to the usual criteria.
- Weight> 35 kg
Who cannot join
- Corticosteroid treatment> 10 mg / day
- Pregnant patient
- Patients under legal protection
- Beneficiary of the state medical aid
Trial locations and contacts
1 site in 1 country.
France1 site
CHU Bicêtre
Le Kremlin-Bicêtre, 94275
Xavier Mariette, MD, PhD, +33 (0)1 45 21 37 51, xavier.mariette@bct.aphp.fr
Gaetane Nocturne, MCU-PH, 0033 1 45 21 37 57, gaetane.nocturne@aphp.fr
About this study
Exploration of pathophysiological mechanisms in chronic inflammatory rheumatism and rare systemic autoimmune diseases with the objective of identifying therapeutic targets.
Read the detailed description
The primary objective is to characterization of the quantitative and qualitative specificities of the different leukocyte sub-populations in patients with chronic inflammatory rheumatism and rare systemic autoimmune diseases. We will perform an exploratory descriptive study whom primary endpoint will be to assess by FACS the phenotype of the specific leukocyte subsets. In addition, we will characterize the protein and transcriptomic signature associated with the conditions for which we have obtained preliminary data showing their potential involvement in autoimmunity (i.e: IL7 pathway, IFN signature).
- Conditions
- Systemic Autoimmune Disease, Chronic Inflammatory Rheumatism, Sjogren's Syndrome, Spondyloarthritis, Rheumatoid Arthritis, Systemic Lupus Erythematosus
- Being tested
- blood sample
- Keywords
- leukocytes, macrophages, lymphocytes, rare systemic autoimmune diseases, chronic inflammatory rheumatism
- Medical subject headings
- Sjogren's Syndrome, Spondylarthritis, Arthritis, Rheumatoid, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleOther
sampling of blood for research during routine care
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of the quantitative and qualitative specificities of the different leukocyte subpopulations in patients with chronic inflammatory rheumatism and rare systemic autoimmune diseases
Proportion of different leukocytes subset
Measured: At the end of the study (5 years)
Secondary outcomes (3)
Protein study (ELISA on serum) : IL7
levels of IL7 and other cytokines
Measured: At the end of the study (5 years)
Transcriptome study (RNA) : mRNA levels
assessement of different mRRNA involved in Il7/IFN pathways by molecular biology techniques (RNAseq, qPCR, nano string)
Measured: At the end of the study (5 years)
Genomic study (DNA) : SNPs
Determination of the genotype of different SNPs involved in IL7/IFN pathways
Measured: At the end of the study (5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start1 Mar 2021 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Autoimmune DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gaetane Nocturne, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749875
- Sponsor's protocol ID
- APHP210093
- Acronym
- LIMA
- Status last verified
- Feb 2021
- First submitted
- 6 Feb 2021
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Leukocyte Populations in Patients With Chronic Inflammatory
- ClinicalTrials.gov ID
- NCT04749875
- Acronym / sponsor ID
- LIMA / APHP210093
- Conditions
- Systemic Autoimmune Disease, Chronic Inflammatory Rheumatism, Sjogren's Syndrome, Spondyloarthritis, Rheumatoid Arthritis, Systemic Lupus Erythematosus
- Keywords
- leukocytes, macrophages, lymphocytes, rare systemic autoimmune diseases, chronic inflammatory rheumatism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 11 Feb 2021 (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.
Exploration of pathophysiological mechanisms in chronic inflammatory rheumatism and rare systemic autoimmune diseases with the objective of identifying therapeutic targets.
Detailed description
The primary objective is to characterization of the quantitative and qualitative specificities of the different leukocyte sub-populations in patients with chronic inflammatory rheumatism and rare systemic autoimmune diseases. We will perform an exploratory descriptive study whom primary endpoint will be to assess by FACS the phenotype of the specific leukocyte subsets. In addition, we will characterize the protein and transcriptomic signature associated with the conditions for which we have obtained preliminary data showing their potential involvement in autoimmunity (i.e: IL7 pathway, IFN signature).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with chronic inflammatory rheumatism and rare systemic autoimmune diseases
Key inclusion criteria (4 listed)
- Age ≥18 years
- Patient who did not express his opposition
- Patients with chronic inflammatory rheumatism and rare systemic autoimmune diseases (pSS, lupus, scleroderma, myositis, unclassified connectivitis) diagnosed according to the usual criteria.
- Weight> 35 kg
Key exclusion criteria (4 listed)
- Corticosteroid treatment> 10 mg / day
- Pregnant patient
- Patients under legal protection
- Beneficiary of the state medical aid
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 |
|---|---|---|
| blood samplesampling of blood for research during routine care | Other | – |
Primary outcome
Characterization of the quantitative and qualitative specificities of the different leukocyte subpopulations in patients with chronic inflammatory rheumatism and rare systemic autoimmune diseases
Time frame: At the end of the study (5 years)
Proportion of different leukocytes subset
3 secondary outcomes
Protein study (ELISA on serum) : IL7
Time frame: At the end of the study (5 years)
Transcriptome study (RNA) : mRNA levels
Time frame: At the end of the study (5 years)
Genomic study (DNA) : SNPs
Time frame: At the end of the study (5 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Systemic Autoimmune Disease
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
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.
Gaetane Nocturne principal investigator
APHP
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 Autoimmune Disease and Chronic Inflammatory Rheumatism, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xavier MARIETTE (00 33 1 45 21 37 58, xavier.mariette@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of the quantitative and qualitative specificities of the different leukocyte subpopulations in patients with chronic inflammatory rheumatism and rare systemic autoimmune diseases (time frame: At the end of the study (5 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 11 Feb 2021.