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Lysophosphatidic Acid / Autotaxin Axis in Rheumatoid Lung Disease (LYSLUNG)

Primary Purpose

Rheumatoid Arthritis

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Quantitative ATX and LPA determination in plasma and sputum

About this trial

This is an interventional basic science trial for Rheumatoid Arthritis focused on measuring Rheumatoid arthritis, Interstitial lung disease, Autotaxin, Lysophosphatidic acid

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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.

Sites / Locations

Hôpital Lyon SudRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Controls

Cases

Arm Description

Patients with RA and without ILD

Patients with RA and ILD

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04284735

First Posted

February 18, 2020

Last Updated

July 26, 2021

Sponsor

Hospices Civils de Lyon

1. Study Identification

Unique Protocol Identification Number

NCT04284735

Brief Title

Lysophosphatidic Acid / Autotaxin Axis in Rheumatoid Lung Disease

Acronym

LYSLUNG

Official Title

Role of Lysophosphatidic Acid and Autotaxin in Rheumatoid Arthritis-associated Interstitial Lung Disease

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

March 3, 2021 (Actual)

Primary Completion Date

September 2023 (Anticipated)

Study Completion Date

September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis, Interstitial lung disease, Autotaxin, Lysophosphatidic acid

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Controls

Arm Type

Other

Arm Description

Patients with RA and without ILD

Arm Title

Cases

Arm Type

Other

Arm Description

Patients with RA and ILD

Intervention Type

Other

Intervention Name(s)

Quantitative ATX and LPA determination in plasma and sputum

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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 Outcome Measure Information:

Title

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

Description

Time Frame

Month 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fabienne COURY-LUCAS, MD

Phone

04 78 86 56 95

Ext

+33

fabienne.coury@chu-lyon.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fabienne COURY-LUCAS, MD

Organizational Affiliation

Hospices Civils de Lyon

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hôpital Lyon Sud

City

Pierre-Bénite

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fabienne COURY-LUCAS, MD

Phone

04 78 86 56 95

Ext

+33

fabienne.coury@chu-lyon.fr

First Name & Middle Initial & Last Name & Degree

Fabienne COURY-LUCAS, MD

12. IPD Sharing Statement

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Lysophosphatidic Acid / Autotaxin Axis in Rheumatoid Lung Disease

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