Tofacitinib in the Treatment of Rheumatoid Arthritis-related Interstitial Lung Disease. (NCT05246293) | Clinical Trial Compass
UnknownPhase 2
Tofacitinib in the Treatment of Rheumatoid Arthritis-related Interstitial Lung Disease.
Mexico60 participantsStarted 2022-08-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
What they're measuring
1
Incidence and severity of adverse events
Timeframe: 52 weeks
Trial details
NCT IDNCT05246293
SponsorNational Institute of Respiratory Diseases, Mexico