Tofacitinib in the Treatment of Rheumatoid Arthritis-related Interstitial Lung Disease.
60 patients around the world
Available in Mexico
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 tofacitinib 5 mg BID for 12 months.
Objectives
Primary objectives:
1. To evaluate the safety and tolerability of tofacitinib 5 mg PO BID as monotherapy for
managing RA-ILD in RA-ILD patients.
2. To evaluate the pulmonary function of patients treated with tofacitinib PO BID as
monotherapy to manage RA-ILD in RA-ILD patients, at baseline, at three months of
follow-up, at six months of follow-up, and one year of follow-up.
3. To estimate the efficacy of tofacitinib 5 mg PO BID as monotherapy for the management of
RA-ILD, in RA-ILD patients, at three months of follow-up, at six months of follow-up,
and at one year of follow-up, according to the ACR 20, 50, 70 response criteria, and the
following disease activity scores index: DAS 28, CDAI and SDAI.
All the included patients will receive Tofacitinib in doses of 5 mg BID until the end of the
protocol.
National Institute of Respiratory Diseases, Mexico
1Research sites
60Patients around the world
Requirements for the patient
From 18 Years
All Gender
Medical requirements
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.
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.
History of drug abuse or alcoholism.
History of any malignancy
Patients with an FVC < 40% of what is expected will be excluded from the study.
Sites
Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas
Recruiting
Calz. de Tlalpan 4502, Belisario Domínguez Secc 16, Tlalpan, Ciudad de México
StudyRAILDTo
SponsorNational Institute of Respiratory Diseases, Mexico