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Study of Leukocyte Populations in Patients With Chronic Inflammatory (LIMA)

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ClinicalTrials.gov Identifier: NCT04749875
Recruitment Status : Not yet recruiting
First Posted : February 11, 2021
Last Update Posted : February 11, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date February 6, 2021
First Posted Date February 11, 2021
Last Update Posted Date February 11, 2021
Estimated Study Start Date March 1, 2021
Estimated Primary Completion Date March 1, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 6, 2021)		 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: February 6, 2021)
  • Protein study (ELISA on serum) : IL7 [ Time Frame: At the end of the study (5 years) ]
    levels of IL7 and other cytokines
  • Transcriptome study (RNA) : mRNA levels [ Time Frame: At the end of the study (5 years) ]
    assessement of different mRRNA involved in Il7/IFN pathways by molecular biology techniques (RNAseq, qPCR, nano string)
  • Genomic study (DNA) : SNPs [ Time Frame: At the end of the study (5 years) ]
    Determination of the genotype of different SNPs involved in IL7/IFN pathways
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of Leukocyte Populations in Patients With Chronic Inflammatory
Official Title Study of Leukocyte Populations in Patients With Chronic Inflammatory
Brief Summary 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
whole blood, serum,
Sampling Method Non-Probability Sample
Study Population Adult patients with chronic inflammatory rheumatism and rare systemic autoimmune diseases
Condition
  • Systemic Autoimmune Disease
  • Chronic Inflammatory Rheumatism
  • Sjogren's Syndrome
  • Spondyloarthritis
  • Rheumatoid Arthritis
  • Systemic Lupus Erythematosus
Intervention Other: blood sample
sampling of blood for research during routine care
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: February 6, 2021)		 1500
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 1, 2026
Estimated Primary Completion Date March 1, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria

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:

  • Corticosteroid treatment> 10 mg / day
  • Pregnant patient
  • Patients under legal protection
  • Beneficiary of the state medical aid
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Xavier MARIETTE 00 33 1 45 21 37 58 xavier.mariette@aphp.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04749875
Other Study ID Numbers APHP210093
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Assistance Publique - Hôpitaux de Paris
Original Responsible Party Same as current
Current Study Sponsor Assistance Publique - Hôpitaux de Paris
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Gaetane Nocturne APHP
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date February 2021