Status:
UNKNOWN
Lysophosphatidic Acid / Autotaxin Axis in Rheumatoid Lung Disease
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-70 years
Phase:
NA
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 i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04284735
Start Date
March 3 2021
End Date
September 1 2023
Last Update
July 27 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hôpital Lyon Sud
Pierre-Bénite, France