Effects of tofacitinib vs methotrexate on clinical and molecular disease activity markers in joints and lungs in early rheumatoid arthritis - PULMORA

Västra Götalandsregionen0 个研究点目标入组 145 人开始时间: 2019年11月19日最近更新: 2024年4月2日

适应症

试验速览

暂无简介。

•1. Diagnosis of seropositive (i.e., presence of RF and/or anti-CCP antibodies) RA according to the ACR/EULAR 2010 criteria within 24 months.
•2. No previous treatment with DMARDs. History of prednisone use is allowed but should have been discontinued 2 weeks before baseline measurement.
•3. Active disease with =2 painful and =2 swollen joints in 66/68 joints and CRP =2.0 mg/dl
•4. Aged 18–80 years
•5. Willing to undergo HRCT and PFTs
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 120
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 25

•1. Current active inflammatory joint disease other than RA.
•2. 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.
•3. 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.
•4. Primary or secondary immunodeficiency (history of, or currently active), including known history of HIV infection.
•5. 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.
•6. Pregnant or lactating women. Serum human chorionic gonadotropin will be measured prior to the first dosing of study drugs.
•7. Positive tests for hepatitis B (HBsAg or HBV DNA) or hepatitis C serology.
•8. History of herpes zoster infection during last 10 years.
•9. History of venous thromboembolism or diverticulitis.
•10. Positive tuberculosis history and/or positive Quantiferon test.
•11. Hemoglobin <90 g/L.
•12. Absolute neutrophil count (ANC) <1.5 ? 103/?L.
•13. ASAT or ALAT >2.0 times the upper limit of normal.

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