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

  • STATUS
    Recruiting
  • End date
    Mar 2, 2025
  • participants needed
    60
  • sponsor
    National Institute of Respiratory Diseases, Mexico
Updated on 18 April 2022
pneumonia
rituximab
prednisone
tofacitinib
tuberculosis
azathioprine
leflunomide
tocilizumab
interstitial lung disease
ciclosporin
lung biopsy
anti-tnf-alpha therapy

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.

Description

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.

Details
Condition Rheumatoid Arthritis, Interstitial Lung Disease
Treatment tofacitinib
Clinical Study IdentifierNCT05246293
SponsorNational Institute of Respiratory Diseases, Mexico
Last Modified on18 April 2022

Eligibility

Yes No Not Sure

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

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. 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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