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Justification AnD evaluation, in pOlymyalgia RhEumatica, of BARIcitinib versus placebo (JADORE-BARI study)
EU CTIS ID: 2024-518385-26-01
What this study is testing
To demonstrate the ability of baricitinib 4 mg plus short GCs treatment in comparison to placebo plus short GCs treatment to obtain a disease activity [PMR-AS-CRP] lower or equal to 10 without oral GCs (prednisone or prednisolone) at week 24 in PMR patients.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Clinical evidence of giant cell arteritis.
- 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.
- Treatment by probenecid.
- Alkaline phosphatase (ALP) ≥2 x ULN.
- Current smoker if age >65 years.
See the full eligibility 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
- Clinical evidence of giant cell arteritis.
- 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.
- Treatment by probenecid.
- Alkaline phosphatase (ALP) ≥2 x ULN.
- Current smoker if age >65 years.
- Patient under court protection or protected adults
- 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.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.