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