Abatacept in earLy Onset Polymyalgia Rheumatica: Study ALORS (ALORS)
Polymyalgia Rheumatica
About this trial
This is an interventional treatment trial for Polymyalgia Rheumatica
Eligibility Criteria
Inclusion Criteria:
- Age older than 50 years
- Fulfilling ACR/EULAR criteria
- Disease duration≤6 months
- No steroid since 2 weeks prior randomization
- PMR-AS≥ 17
- Absence of signs or symptoms of other musculoskeletal or connective tissue conditions
- Able to give informed consent
- Concomitant treatments with methotrexate or hydroxychloroquine are not permitted.
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 surgical procedure or medical history, blood abnormalities or any clinical condition that compromises inclusion
- History of malignant neoplasm within the last 5 years.
- Current active infection not controlled
- Detailed exclusion criteria related to prior or concomitant therapy, general safety and laboratory data are reported in the protocol
Sites / Locations
- CHRU de Brest
- CH Le Mans
- CH de Morlaix
- CH St-Malo
- CHU Strasbourg
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Experimental group
Control group
Subcutaneous abatacept every weeks during 3 months (W0 to W11). Then, at W12, 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). Dosage of GCs will be decreased between W16 and W24 (1mg every week) in each arm according to PMR-AS (PMR-AS < 10: decrease, PMR-AS > 17 increase to previous dosage, 10 ≤ PMR-AS ≤ 17: stable dose). If PMR-AS ≤10, the patients wont receive any treatment until a flare.
Subcutaneous placebo every week during 3 months (W0 to W11). Then, at week 12, 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). Dosage of GCs will be decreased between W16 and W24 (1mg every week) in each arm according to PMR-AS (PMR-AS < 10: decrease, PMR-AS > 17 increase to previous dosage, 10 ≤ PMR-AS ≤ 17: stable dose). If PMR-AS ≤10, the patients won't receive any treatment until a flare.