Effects of Tofacitinib vs Methotrexate on Rheumatoid Arthritis Interstitial Lung Disease

Who can take part

• Diagnosis of seropositive (i.e., presence of RF and/or anti-CCP antibodies) rheumatoid arthritis (RA) according to the ACR/EULAR 2010 criteria within 24 months
• No previous treatment with disease modifying anti-rheumatic drugs (DMARDs). History of prednisone use is allowed but should have been discontinued 2 weeks before baseline measurement
• Active disease with ≥2 painful and ≥2 swollen joints in 66/68 joints and CRP ≥2.0 mg/L
• Aged 18-80 years
• The subject has given written consent to participate in the study

Who cannot take part

• Women of childbearing potential not willing or able to use highly effective methods of birth control per ICH M3 (R2) for 28 days prior and 3 months after end of study
• Active infection (excluding fungal infections of nail beds) requiring i.v. anti-infectives within 4 weeks, or oral anti-infectives within 2 weeks prior to baseline
• Current active inflammatory joint disease other than RA
• Significant and/or uncontrolled cardiac, pulmonary disease, nervous system, renal, hepatic, endocrine or gastrointestinal disorders or severe RA which in the investigator's opinion would preclude patient participation
• Malignancy within the past 5 years, except for successfully treated cervical carcinoma in situ, basal cell and squamous cell carcinoma of the skin, with no evidence of recurrence or metastatic disease for at least 3 years
• Primary or secondary immunodeficiency (history of, or currently active), including known history of HIV infection
• Positive tests for hepatitis B (HBsAg or HBV DNA),hepatitis C serology or SARS-CoV2
• History of herpes zoster infection during last 10 years
• History or risk of venous thromboembolism or diverticulitis
• Positive tuberculosis history and/or positive Quantiferon test
• Hemoglobin <90 g/L
• Absolute neutrophil count < 1500 cells/uL
• Pregnant or lactating women; For subjects in part II the following exclusion criteria also apply:
• ASAT or ALAT >2.0 times the upper limit of normal
• High or very high risk (≥ 5%) of cardiovascular death within 10 years by SCOREx1,5
• Multiple incidental solid/subsolid lung nodules of size ≥6 mm, single incidental solid lung nodules ≥8 mm