Informations générales (source: ClinicalTrials.gov)
Role of Lysophosphatidic Acid and Autotaxin in Rheumatoid Arthritis-associated Interstitial Lung Disease (LYSLUNG)
Interventional
N/A
Hospices Civils de Lyon (Voir sur ClinicalTrials)
mars 2021
septembre 2023
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Hôpital Lyon Sud - Pierre-Bénite - France | Fabienne COURY-LUCAS, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
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
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.