Baricitinib for Polymyalgia rheumatica

Inclusion criteria

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

Exclusion criteria

• {"criterion_text":"- Clinical evidence of giant cell arteritis.\n- 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).\n- Current active uncontrolled infection.\n- Treatment by probenecid.\n- Alkaline phosphatase (ALP) ≥2 x ULN.\n- Current smoker if age >65 years.\n- Patient under court protection or protected adults\n- Total bilirubin level (TBL) ≥1.5 x ULN.\n- Neutropenia (absolute neutrophil count <1000 cells/uL) (<1.00 x 103/uL or <1.00 GI/L).\n- Lymphopenia (lymphocyte count <500 cells/uL) (<0.50 x 103/uL or <0.50 GI/L).\n- Detailed exclusion criteria related to prior or concomitant therapy, general safety and laboratory data are reported in the protocol.\n- Uncontrolled high blood pressure or cardiovascular disease.\n- 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).\n- Clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to PMR\n- Planned major surgical procedure during the study or medical history, blood abnormalities or any clinical condition that compromises inclusion."}

Primary endpoints

• {"endpoint_text":"- The primary outcome is a PMR-AS (CRP) ≤10 (no flare) without steroids at week 24.","definition_or_measurement_approach":"Measured by PMR-AS using CRP; achievement of PMR-AS (CRP) ≤10 without oral glucocorticoids (prednisone or prednisolone) at week 24."}

Secondary endpoints

• {"endpoint_text":"- PMR-AS (CRP) ≤10 (no flare) without steroids at week 24\n- PMR-AS (CRP) ≤10 (no flare) without steroids at week 12\n- PMR-AS (CRP) ≤10 (no flare) without steroids at week 12\n- PMR-AS (CRP) ≤10 (no flare) without steroids at week 24\n- PMR-AS (CRP) ≤10 (no flare) without steroids at week 12\n- Exploratory End Points (see synopsis)\n- PMR-AS (CRP) ≤10 (no flare) without steroids at week 36\n- PMR-AS (CRP) ≤10 (no flare) without steroids at week 36\n- PMR-AS (CRP) ≤10 (no flare) without steroids at week 36","definition_or_measurement_approach":"Measured by PMR-AS using CRP; endpoints evaluate achievement of PMR-AS (CRP) ≤10 without oral glucocorticoids at the specified timepoints (weeks 12, 24 and 36). Exploratory endpoints are referenced in the protocol/synopsis."}

Other endpoints

• {"endpoint_text":"- Exploratory End Points (see synopsis)","definition_or_measurement_approach":"Exploratory endpoints are referenced in the protocol synopsis; specific measures not detailed in the Part I data."}

France

Earliest CTIS Part Ii Submission Date

24-06-2025

Latest Decision Or Authorization Date

07-10-2025

Processing Time Days

105

Number Of Sites

22

Number Of Participants

140

Primary sponsor

Full Name

Centre Hospitalier Regional Et Universitaire De Brest

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"Eli Lilly and Company (Lilly)","duties_or_roles":"Monetary support","organisation_type":""}