Tofacitinib in the Treatment of Rheumatoid Arthritis-related Interstitial Lung Disease.

• Status: Not yet recruiting
• Trial end date: 2025-03-02
• Target enrollment: 0
• Participant gender: All

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 is preliminary data that tofacitinib may have a beneficial effect in treating RA-ILD. Tofacitinib may have a double role in treating RA-ILD: treat RA disease activity and an anti-fibrotic possible impact. Moreover, tofacitinib may be used as monotherapy for the treatment of rheumatoid arthritis (RA) This is a phase IIa clinical trial to evaluate the safety and tolerability of tofacitinib in RA-ILD patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Respiratory Diseases, Mexico
• Treatments: Tofacitinib

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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