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

RecruitingPhase 3Ages 50 Years - anyAllUniversity Hospital, Brest
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In plain words

What the trial is, and whether it could suit you

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 \<7; moderate activity 7 to 17; high activity \>17), flare (\>10), remission (\<1.5), but also to decide if treatment has to be decreased, unchanged or increased (PMR-AS \<10: decrease, PMR-AS \>20 increase, 10≤ PMR-AS ≤20: stable dose) \[10-12\]. Long term low-dose glucocorticoid (GCs) (prednisone or prednisolone started at 12.5 to 25 mg/day progressively tapere

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 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 \<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). * Patient under court protection or protected adults
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What it tests

  • Baricitinib 4 MG Oral Tablet
  • Baricitinib 2 MG Oral Tablet
  • Placebo 4 mg
  • Placebo 2 mg
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Where

23 sites
VIDAL François
Aix-en-Provence, France
LEGRAND Jean-Louis
Arras, France
Besançon-CIC
Besançon, France
PRATI Clément
Besançon, France
CHU de Bordeaux Pellegrin
Bordeaux, France
Dr Alain SARAUX
Brest, France
RAT Anne-Christine
Caen, France
LESKE Charles
Cholet, France

…and 15 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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