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
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