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:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 1:21 AM
NCT ID:
NCT05246293
Eligibility Criteria:
Inclusion Criteria:
1. Patients must fulfill ACR/EULAR 2010 RA classification criteria.
2. Patients must have an interstitial lung disease confirmed by a high-resolution computed tomography scan or a surgical lung biopsy. Nonspecific interstitial pneumonia, usual interstitial pneumonia, lymphocytic pneumonia, and organized pneumonia, either by HRCT or surgical biopsy, will be included.
3. Patients must be 18 years of age or older.
4. There is no evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis (TB).
5. Patients must discontinue using the non-permitted medications: leflunomide, azathioprine, cyclosporine, tacrolimus, cyclophosphamide, and any biologic disease-modifying drug (bDMDARDs) such as anti-TNF therapy, rituximab, tocilizumab, etc. Patients must have a stable prednisone dose of ≤ 10 mg/ PO/day for at least three months.
6. All patients must have stable doses of prednisone during the last three months of follow-up, and the prednisone dose must be ≤ 10 mg/day. Patients without a prednisone history in the previous three months may also be included in the protocol.
Exclusion Criteria:
1. Seropositivity for the following infections: HIV, HBV, and HCV.
2. Absolute neutrophil count ≤ 1,200/L
3. Absolute platelet count ≤ 100,000 /L
4. Severe renal damage with GFR \< 30 ml/min based on CKD-EPI formula.
5. AST or ALT greater than 1.5 times the upper limit of normal AST and ALT levels
6. Severe hepatic, hematologic, gastrointestinal, cardiac, and neurological disease may put the patient´s life at risk regardless of ILD severity.
7. Severe active infections at baseline evaluation, such as pneumonia, urinary tract infections, meningitis.
8 History of drug abuse or alcoholism. 9. History of any malignancy 10. Patients with an FVC \< 40% of what is expected will be excluded from the study.
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05246293
Study Brief:
Protocol Section:
NCT05246293