Efficacy and Safety of JAK inhibitors in Rheumatoid Arthritis-Associated Interstitial Lung Disease

JRCT ID: jRCT1041230171

Registered date:15/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Rheumatoid arthritis
• Date of first enrollment: 15/03/2024
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Administering JAK inhibitors for rheumatoid arthritis complicated by interstitial lung disease

Outcome(s)

Primary Outcome

Analysis of efficacy for RA-ILD
Changes in RA-ILD image scores at baseline and 1, 2 years after starting treatment of JAK inhibitors

Secondary Outcome

Changes in respiratory function and mMRC
Respiratory related adverse events (infection/exacerbation of ILD)
Drug tolerability
Dose sparing effect of steroids
Efficacy for RA disease activity (CDAI)
Efficacy for RA functionality (HAQ-DI)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients diagnosed with RA according to the 2010 ACR/EULAR rheumatoid arthritis classification criteria
(2) Patients diagnosed with ILD based on the 2013 ATS/ERS (American Thoracic Society/European Respiratory Society) guidelines for idiopathic interstitial pneumonia.
(3) Patients who still have obvious symptoms caused by the disease even after appropriate treatment with at least one anti-rheumatic drug, including MTX.
(4) Patients to whom JAK inhibitors are administered for the first time by the investigator (or co-investigator) Five drugs are currently approved for RA in Japan: Tofacitinib (Xeljanz), Baricitinib (Olumiant), Peficitinib (Smyraf), Upadacitinib (Rinvoq), and Filgotinib (Jyseleca).
(5) Patients over 18 years old.
(6) Patients who have received sufficient explanation and informed written consent of their own free will to participate in this study.

Exclude criteria

(1) Pregnant women and patients who may be pregnant.
(2) Patients with serious infections (sepsis, etc.).
(3) Patients with active tuberculosis.
(4) Patients with non-tuberculous mycobacterial disease.
(5) Patients with severe liver dysfunction.
(6) Patients with severe renal dysfunction.
(7) Patients whose recent peripheral blood test (within 3 months before obtaining consent) shows either a lymphocyte count of less than 500/mm3, a neutrophil count of less than 1000/mm3, or a hemoglobin value of less than 8g/dl.
(8) Patients with malignant disease.
(9) Patients who cannot stop immunosuppressants.
(10) Patients who are taking steroids in excess of 10mg/day in terms of prednisolone.
(11) Patients with acute exacerbation of ILD or severe decline in pulmonary function.
(12) Patients whose participation in this study is judged to be inappropriate by the principal investigator or co-investigator.

Related Information

• Primary Sponsor: Ohshima Shiro
• Source(s) of Monetary Support: Grant-in-Aid for Clinical Research from the National Hospital Organization