Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-24 @ 10:19 PM
NCT ID:
NCT04284735
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04284735
Study Brief:
Protocol Section:
NCT04284735