BridgeMD
Compares treatment options for Polymyalgia Rheumatica (PMR)
Official title Justification And Evaluation of Baricitinib Plus Corticosteroids Versus corticosteroiDs Alone in pOlymyalgia RhEumatica
ClinicalTrials.gov ID: NCT07279688
What this study is testing
What is Baricitinib 4 MG Oral Tablet?
Baricitinib 4 MG Oral Tablet is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for polymyalgia rheumatica (pmr).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Polymyalgia rheumatic (PMR) is an inflammatory rheumatic disease affecting the elderly. The diagnosis is based on established ACR/EULAR classification criteria.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
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.
You likely can't join if
- 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...
- 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.
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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Aix-en-Provence, France
- Arras, France
- Besançon, France
- Bordeaux, France
- Brest, France
- Caen, France
- Cholet, France
- Clermont-Ferrand, France
- Dijon, France
- Le Kremlin-Bicêtre, France
- Le Mans, France
- Lille, France
- Marseille, France
- Morlaix, France
- Nice, France
- Paris, France
- Reims, France
- Strasbourg, France
- Toulouse, France
- Tours, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aix-en-Provence, France; Arras, France; Besançon, France; Bordeaux, France; Brest, France; Caen, France and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.