Last updated: April 26, 2023
Sponsor: National Institute of Respiratory Diseases, Mexico
Overall Status: Active - Recruiting
Phase
2
Condition
Dermatomyositis (Connective Tissue Disease)
Musculoskeletal Diseases
Joint Injuries
Treatment
N/AClinical Study ID
NCT05246293
C17-21
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients must fulfill ACR/EULAR 2010 RA classification criteria.
- Patients must have an interstitial lung disease confirmed by a high-resolutioncomputed tomography scan or a surgical lung biopsy. Nonspecific interstitialpneumonia, usual interstitial pneumonia, lymphocytic pneumonia, and organizedpneumonia, either by HRCT or surgical biopsy, will be included.
- Patients must be 18 years of age or older.
- There is no evidence of active, latent, or inadequately treated infection withMycobacterium tuberculosis (TB).
- Patients must discontinue using the non-permitted medications: leflunomide,azathioprine, cyclosporine, tacrolimus, cyclophosphamide, and any biologicdisease-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 threemonths.
- All patients must have stable doses of prednisone during the last three months offollow-up, and the prednisone dose must be ≤ 10 mg/day. Patients without a prednisonehistory in the previous three months may also be included in the protocol.
Exclusion
Exclusion Criteria:
- Seropositivity for the following infections: HIV, HBV, and HCV.
- Absolute neutrophil count ≤ 1,200/L
- Absolute platelet count ≤ 100,000 /L
- Severe renal damage with GFR < 30 ml/min based on CKD-EPI formula.
- AST or ALT greater than 1.5 times the upper limit of normal AST and ALT levels
- Severe hepatic, hematologic, gastrointestinal, cardiac, and neurological disease mayput the patient´s life at risk regardless of ILD severity.
- Severe active infections at baseline evaluation, such as pneumonia, urinary tractinfections, meningitis.
8 History of drug abuse or alcoholism. 9. History of any malignancy 10. Patients with anFVC < 40% of what is expected will be excluded from the study.
Study Design
Total Participants: 60
Study Start date:
August 08, 2022
Estimated Completion Date:
March 02, 2025
Study Description
Connect with a study center
Instituto Nacional de Enfermedades Respiratorias, Ismael Cosío Villegas
Mexico City, Tlalpan 14080
MexicoActive - Recruiting

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