Justification AnD evaluation, in pOlymyalgia RhEumatica, of BARIcitinib versus placebo (JADORE-BARI study)

Ki vehet részt

• At least 50 years of age
• Fulfilling ACR/EULAR classification criteria for PMR newly diagnosed or treatment resistant
• No GCs or GCs <15 mg/day since at least 15 days prior to planned randomization
• PMR-AS-CRP >17
• Absence of other inflammatory arthropathy, connective tissue diseases or vasculitis
• Able to give informed consent
• French health insurance holder

Ki nem vehet részt

• High risk of VTE because of a history of VTE (DVT and/or PE) within 12 weeks prior to randomization or a history of recurrent (>1) VTE (counting co-occurring DVT+PE as 1 single event)
• History of malignant neoplasm within the last 5 years (or 3 years in case of cervical carcinoma, basal cell or squamous epithelial skin cancer resected with no evidence of recurrence or metastatic disease)
• Current active uncontrolled infection
• Uncontrolled high blood pressure or cardiovascular disease
• Clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to PMR
• Planned major surgical procedure during the study or medical history, blood abnormalities or any clinical condition that compromises inclusion
• Alkaline phosphatase (ALP) ≥2 x ULN
• Total bilirubin level (TBL) ≥1.5 x ULN
• Neutropenia (absolute neutrophil count <1000 cells/uL) (<1.00 x 103/uL or <1.00 GI/L)
• Lymphopenia (lymphocyte count <500 cells/uL) (<0.50 x 103/uL or <0.50 GI/L)
• Detailed exclusion criteria related to prior or concomitant therapy, general safety and laboratory data are reported in the protocol
• Current smoker if age >65 years
• Clinical evidence of giant cell arteritis
• Treatment by probenecid
• Patient under court protection or protected adults