ClinicalTrials.gg
Status unknownNCT04749875LIMAUpdated Feb 11, 2021

Study of Leukocyte Populations in Patients With Chronic Inflammatory

An observational study in Systemic Autoimmune Disease, Chronic Inflammatory Rheumatism and Sjogren's Syndrome, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-11.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,500
Ages
18 Years and older
Sex
All
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Study summary

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).

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Conditions studied

  • 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
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In context

Sjogren's Syndrome

381 studies on the registry are indexed under Sjogren's Syndrome; 106 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 114 across 115 observational studies indexed under Sjogren's Syndrome.

Browse Sjogren's Syndrome studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,576 studies on the registry; 1,028 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients with chronic inflammatory rheumatism and rare systemic autoimmune diseases

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Corticosteroid treatment> 10 mg / day
  • Pregnant patient
  • Patients under legal protection
  • Beneficiary of the state medical aid
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • Otherblood sample

    sampling of blood for research during routine care

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What researchers measure

Primary outcomes

  1. 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

    Time frame: At the end of the study (5 years)

Secondary outcomes

  1. Protein study (ELISA on serum) : IL7

    levels of IL7 and other cytokines

    Time frame: At the end of the study (5 years)

  2. Transcriptome study (RNA) : mRNA levels

    assessement of different mRRNA involved in Il7/IFN pathways by molecular biology techniques (RNAseq, qPCR, nano string)

    Time frame: At the end of the study (5 years)

  3. Genomic study (DNA) : SNPs

    Determination of the genotype of different SNPs involved in IL7/IFN pathways

    Time frame: At the end of the study (5 years)

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Study locations

1 site
  • CHU Bicêtre
    Le Kremlin-Bicêtre, 94275, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Mar 2021; primary completion for Mar 2026, 60 months later.

Of 48 non-industry observational studies under Sjogren's Syndrome, half reached primary completion within 64 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 124. This study's planned 60 months is close to that.

Counting every sponsor, half of 50 studies reached it within 64 months; a quarter within 21 and three quarters within 124.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 6, 2021
First posted
Feb 11, 2021
StartEst.
Mar 1, 2021
Primary completionEst.
Mar 1, 2026
CompletionEst.
Mar 1, 2026
Last update
Feb 11, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04749875
Responsible party
Sponsor
First posted
Feb 11, 2021
Start date
Mar 1, 2021 (estimated)
Primary completion
Mar 1, 2026 (estimated)
Completion
Mar 1, 2026 (estimated)
Last update
Feb 11, 2021

Study contacts

Xavier MARIETTE
Contact
xavier.mariette@aphp.fr
00 33 1 45 21 37 58
Gaetane Nocturne
principal investigator · APHP

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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