drugset / Trial / NCT04311567

Effects of Tofacitinib vs Methotrexate on Rheumatoid Arthritis Interstitial Lung Disease

NCT04311567

RandomizedParallel-groupSingle-blindTreatment

Summary

Pulmonary abnormalities are present in up to 60% of patients with early rheumatoid arthritis (RA), and up to 10% of the patients will develop clinical interstitial lung disease (ILD). Recent data indicate that inhibition of Janus kinase is beneficial for this extra-articular manifestation. Our goal is to determine whether tofacitinib is an effective and safe treatment, compared to standard-of-care methotrexate, for subclinical and clinical ILD in patients with early RA. The study also explores disease mechanisms in lungs and joints, to identify potential biomarkers for diagnosis, prognosis, and response to treatment of RA-ILD.

Timeline

Start
2020-11-07
Primary completion
2023-11-30
Completion
2024-03-26

Drugs

EvaluationDrugModalityDoseRoute
Comparator Methotrexate Small molecule 20 mg Oral
Subject Tofacitinib Small molecule 5 mg Oral