CClinicalTrials.gg
Status unknownNCT04284735LYSLUNGUpdated Jul 27, 2021

Lysophosphatidic Acid / Autotaxin Axis in Rheumatoid Lung Disease

An interventional study of Quantitative ATX and LPA determination in plasma and sputum in Rheumatoid Arthritis, sponsored by Hospices Civils de Lyon. Status unknown at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-07-27.

Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Rheumatoid arthritis (RA) is a common chronic systemic autoimmune relapsing disease characterized by joint inflammation. Beside arthritis leading to progressive joint damage and loss of function, RA is also associated to extraarticular inflammatory conditions such as interstitial lung disease (ILD). This one develops in 30% of all RA patients with a median survival expectancy of 3 to 10 years once symptomatic. Unfortunately, there is no medical care recommendation so far as the pathophysiology is unknown. However, ILD share many similarities with idiopathic pulmonary fibrosis (IPF).

Autotaxin (ATX), due to its lysophospholipase activity, produces a bioactive lipid, lysophosphatidic acid (LPA) under inflammation. LPA has pleiotropic actions inducing cell proliferation, survival, motility and differentiation. Increased ATX and LPA levels have been detected in synovial fluid of RA patients and in IPF patients. ATX is also currently the target for a phase 3 clinical trial in IPF.

Given the previous described role of ATX/LPA axis in arthritis and inflammation-induced bone loss in RA and the similarities between RA-ILD and IPF, the investigators hypothesized that ATX/LPA axis may be also an attractive drug target for this pulmonary condition in RA and therefore that ATX and LPA may be increased in sputum from RA patients with ILD in comparison with sputum from RA patients without ILD.

02

Conditions studied

  • Rheumatoid Arthritis

Keywords

  • Rheumatoid arthritis
  • Interstitial lung disease
  • Autotaxin
  • Lysophosphatidic acid
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's planned enrollment of 40 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

General inclusion criteria

  • Subject aged ≥ 18 and ≤ 70 years
  • Patient with RA with ACPA in the state phase, meeting ACR / EULAR 2010 criteria
  • For female subjects:

    • Likely to procreate: negative pregnancy test at the inclusion visit and use of an effective method of contraception (hormonal contraceptives, intrauterine devices, vasectomized partner, abstinence) started at least 1 month before inclusion and continued during the entire study.
    • Inability to procreate: menopause (absence of a rule for at least 1 year) or hysterectomy or bilateral oophorectomy or tubal ligation.
  • Subject having given written consent to participate in the study
  • Subject affiliated to the Social Security scheme or benefiting from an equivalent scheme

Additional inclusion criteria for cases (RA patients with PID):

  • PID is defined as damage compatible with the thoracic scanner in thin sections according to international criteria with or without associated clinical signs.

Additional inclusion criteria for control patients (RA patients without symptomatology without PID)

  • No functional lung complaints

Exclusion criteria

Exclusion Criteria:

General exclusion criteria

  • Vulnerable patient within the meaning of current French legislation (deprived of liberty by judicial or administrative decision, under guardianship or curatorship or under the protection of justice)
  • Patient not fluent in French
  • Woman breastfeeding or planning a pregnancy for the duration of the study
  • Patient in exclusion period after participating in another clinical trial or in the process of participating in another clinical trial involving an experimental product
  • Patient with occupational exposure to particles known to be responsible for PID (silica, etc.)
  • Patient with an autoimmune disease other than RA or an auto-inflammatory disease

Non-inclusion criteria for cases (RA patients with PID):

  • Patient with a history of asthma, COPD or any other pulmonary pathology or pulmonary symptom unrelated to PID

Non-inclusion criteria for control patients (RA patients without PID)

  • Patient with a history of asthma, COPD, any other pulmonary pathology, any pulmonary symptom or any pulmonary CT abnormality.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Other
    Controls

    Patients with RA and without ILD

    Other: Quantitative ATX and LPA determination in plasma and sputum

  • Other
    Cases

    Patients with RA and ILD

    Other: Quantitative ATX and LPA determination in plasma and sputum

Interventions

  • OtherQuantitative ATX and LPA determination in plasma and sputum

    Determination of ATX and LPA levels in plasma and sputum from RA-ILD patients ("cases") and in plasma and sputum from RA patients without ILD ("controls") after sputum induction using hypertonic saline inhalation

06

What researchers measure

Primary outcomes

  1. ATX and LPA levels in sputum from RA patients with ILD in comparison with sputum from RA patients without ILD

    All the samples will be frozen and ATX and LPA levels will be assessed in the plasma and sputum at the same time, at the end of the recruitment.

    Time frame: Month 30

Secondary outcomes

  1. Correlation between ATX and LPA levels and severity of RA-ILD estimated by tomodensitometry

    Determine the correlation between ATX and LPA levels and the severity of CT scan pulmonary involvement\*. \*Diffuse interstitial lung disease is defined as an attack compatible with the thoracic scanner in thin sections according to international criteria with or without associated clinical signs.

    Time frame: Month 24

07

Study locations

1 of 1 sites recruiting
  • Hôpital Lyon Sud
    Pierre-Bénite, France
    • Fabienne COURY-LUCAS, MD · Contact · fabienne.coury@chu-lyon.fr · 04 78 86 56 95
    • Fabienne COURY-LUCAS, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04284735
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Feb 26, 2020
Start date
Mar 3, 2021
Primary completion
Sep 2023 (estimated)
Completion
Sep 2023 (estimated)
Last update
Jul 27, 2021

Study contacts

Fabienne COURY-LUCAS, MD
Contact
fabienne.coury@chu-lyon.fr
04 78 86 56 95 ext. +33
Fabienne COURY-LUCAS, MD
principal investigator · Hospices Civils de Lyon

Oversight

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 Jul 2021. You cannot join it, but the record below documents what was studied.

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