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Recruiting NCT07279688

Justification And Evaluation of Baricitinib Plus Corticosteroids Versus corticosteroiDs Alone in pOlymyalgia RhEumatica

Conditions: Polymyalgia Rheumatica (PMR)

Sex: All
Ages: 50 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 140
Sponsor: University Hospital, Brest

Location: VIDAL François Aix-en-Provence

Summary

Polymyalgia rheumatic (PMR) is an inflammatory rheumatic disease affecting the elderly. The diagnosis is based on established ACR/EULAR classification criteria. The activity of the disease is evaluated using the PMR-AS, a disease activity score based on morning stiffness, ability to elevate the upper limbs, physician's global disease assessment and pain assessment measured by the patient using VAS, and the C-reactive protein (CRP) level. The PMR-AS-CRP (PMR-AS) is considered as relevant to define disease activity (low activity \17), flare (\>10), remission (\one year by steroids. Our goal is now to demonstrate in a large cohort the ability of a 6-month treatment with baricitinib in comparison to placebo to decrease glucocorticoids and then to maintain low disease activity without corticosteroids in PMR and a good safety profile. Due to the possible lower risk of 2 mg than 4 mg of baricitinib, but probably a lower efficacy, the investigators plan to compare both baricitinib (4 mg and 2 mg) to placebo. The study will be conducted in France.

Eligibility Criteria

Inclusion Criteria: * At least 50 years of age. * Fulfilling ACR/EULAR classification criteria for PMR newly diagnosed or treatment resistant. * No GCs or GCs \17. * Absence of other inflammatory arthropathy, connective tissue diseases or vasculitis. * Able to give informed consent. * French health insurance holder Exclusion Criteria: * Clinical evidence of giant cell arteritis. * Uncontrolled high blood pressure or cardiovascular disease. * 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). * 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. * Current smoker if age \>65 years. * Current active uncontrolled infection. * Treatment by probenecid. * Alkaline phosphatase (ALP) ≥2 x ULN. * Total bilirubin level (TBL) ≥1.5 x ULN. * Neutropenia (absolute neutrophil count \

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Source: ClinicalTrials.gov (NCT07279688). StuddyBuddy aggregates publicly available trial information.