BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica (BACHELOR)
Polymyalgia Rheumatic (PMR)
About this trial
This is an interventional treatment trial for Polymyalgia Rheumatic (PMR)
Eligibility Criteria
Inclusion Criteria:
- At least 50 years of age
- Fulfilling ACR/EULAR criteria for PMR
- Disease duration ≤6 months
- No oral or parenteral steroid since ≥ 2 weeks prior to randomization
- PMR-AS >17
- Absence of connective tissue diseases or vasculitis
- Able to give informed consent
Exclusion Criteria:
- Clinical symptoms of giant cell arteritis
- Uncontrolled high blood pressure or cardiovascular disease
- Clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to PMR
- Planned major surgical procedure during the study.
- 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
- Detailed exclusion criteria related to prior or concomitant therapy, general safety and laboratory data are reported in the protocol
Sites / Locations
- Chu Bordeaux
- CHU BrestRecruiting
- CH Le MansRecruiting
- CHU Montpellier
- Ch Morlaix
- CHU NiceRecruiting
- CHU StrasbourgRecruiting
- Chu Tours
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Experimental group
Control group
Oral baricitinib 4mg/day for 12 weeks. Then, at week 12, if PMR-AS≤10, patients will receive baricitinib 2 mg for 12 weeks. If PMR-AS ≤10, the patients will not receive any treatment until W24 At W24, if PMR-AS>10, they will receive GCs according to the PMR-AS (PMR-AS<10: no GCs, PMR-AS between 10-20: 10mg/day, PMR-AS between 21-30: GCs at 15mg/d and if PMR-AS> 30: 20mg/d or more according to investigator's opinion). Dosage of GCs will be decreased (1 mg every week) or increased according to PMR-AS (PMR-AS < 10: decrease, PMR-AS > 20 increase, 10 ≤ PMR-AS ≤ 20: stable dose) according to investigator's opinion.
Oral placebo every day during 3 months (W12). Then, at week 12, if PMR-AS ≤10, placebo for 12 weeks. If PMR-AS ≤10, the patients do not receive any treatment until a flare. If PMR-AS>10, they will receive GCs according to the PMR-AS (PMR-AS<10: no GCs, PMR-AS between 10-20: 10mg/day, PMR-AS between 21-30: GCs at 15mg/d and if PMR-AS> 30: 20mg/d or more according to investigator's opinion). Dosage of GCs will be decreased (1mg every week) or increased according to PMR-AS (PMR-AS < 10: decrease, PMR-AS > 20 increase, 10 ≤ PMR-AS ≤ 20: stable dose) and according to investigator's opinion.