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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Tofacitinib in doses of 5 mg BID, in RA-ILD patients at stable doses of prednisone ≤ 10 mg/day during the last three months. Patients who met the inclusion criteria of the study protocol will received tofacitinib 5 mg BID for 12 months
Instituto Nacional de Enfermedades Respiratorias, Ismael Cosío Villegas
Mexico City, Tlalpan, Mexico
RECRUITINGIncidence and severity of adverse events
Adverse event: Any untoward medical occurrence in a subject being included in the trial, in which the event may not necessarily have a causal relationship with the treatment. Examples of adverse events are as follows: abnormal test findings, clinically significant symptoms and signs, hypersensitivity reactions, and progression or worsening of RA or RA-ILD.
Time frame: 52 weeks
Forced Vital Capacity (liters)
Forced vital capacity (FVC) on spirometry, the data will be presented as percentages of predicted values, according to sex, age, height, and weight.
Time frame: 52 weeks
Carbon monoxide diffusing capacity (DLCO) (mil/min/mmHg)
The data will be presented as percentages of predicted values, according to sex, age, height, and weight.
Time frame: 52 weeks
6 minutes walk test
walked metters in 6 minutes
Time frame: 52 weeks
Rheumatoid arthritis disease activity according to the simplified disease activity (SDAI) index.
The SDAI index consists of the algebraic sum of the following items: tender joint count, swollen joint count, c-reactive protein, rheumatoid arthritis activity according to the patient, disease activity according to the attending physician.
Time frame: 52 weeks
Rheumatoid arthritis disease activity according to the Disease Activity Score Index (DAS28)
The DAS28 score is calculated with the tender joint count, swollen joint count, eritrosedimentation rate, patients' global health assesment aacording with the following formula DAS28 = ( 0.56 \* sqr(TJC)) + (0.28 \* sqr(SJC)) + ( 0.7 \* ln(VSG)) + (0.014 \* GH)
Time frame: 52 weeks
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