Status:
UNKNOWN
Tofacitinib in the Treatment of Rheumatoid Arthritis-related Interstitial Lung Disease.
Lead Sponsor:
National Institute of Respiratory Diseases, Mexico
Conditions:
Rheumatoid Arthritis
Interstitial Lung Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Nowadays, no single drug is approved to treat rheumatoid arthritis-related interstitial lung disease (RA-ILD). The medical management of this clinical condition is empirical and controversial. There i...
Detailed Description
This is a phase 2 open-label study designed to evaluate the safety and tolerability of tofacitinib in RA-ILD patients. Patients who met the inclusion criteria of the study protocol will receive tofaci...
Eligibility Criteria
Inclusion
- Patients must fulfill ACR/EULAR 2010 RA classification criteria.
- 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.
- Patients must be 18 years of age or older.
- There is no evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis (TB).
- 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.
- 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
- 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 may put the patient´s life at risk regardless of ILD severity.
- 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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Key Trial Info
Start Date :
August 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 2 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05246293
Start Date
August 8 2022
End Date
March 2 2025
Last Update
April 27 2023
Active Locations (1)
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1
Instituto Nacional de Enfermedades Respiratorias, Ismael Cosío Villegas
Mexico City, Tlalpan, Mexico, 14080