Abatacept in earLy Onset Polymyalgia Rheumatica: Study ALORS
Maneno muhimu
Kikemikali
Tarehe
Imethibitishwa Mwisho: | 04/30/2019 |
Iliyowasilishwa Kwanza: | 07/10/2018 |
Uandikishaji uliokadiriwa Uliwasilishwa: | 08/13/2018 |
Iliyotumwa Kwanza: | 08/14/2018 |
Sasisho la Mwisho Liliwasilishwa: | 05/09/2019 |
Sasisho la Mwisho Lilichapishwa: | 05/12/2019 |
Tarehe halisi ya kuanza kwa masomo: | 12/12/2018 |
Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 09/06/2020 |
Tarehe ya Kukamilisha Utafiti: | 09/06/2020 |
Hali au ugonjwa
Uingiliaji / matibabu
Drug: Experimental group
Drug: Control group
Awamu
Vikundi vya Arm
Mkono | Uingiliaji / matibabu |
---|---|
Experimental: Experimental 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. | Drug: Experimental group Subcutaneous abatacept every weeks during 3 months |
Placebo Comparator: Control group 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. | Drug: Control group Subcutaneous placebo every week during 3 months |
Vigezo vya Kustahiki
Zama zinazostahiki Kujifunza | 50 Years Kwa 50 Years |
Jinsia Inastahiki Kujifunza | All |
Hupokea Wajitolea wa Afya | Ndio |
Vigezo | 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 |
Matokeo
Hatua za Matokeo ya Msingi
1. Following of one biological parameter (CRP) [12 weeks]
Hatua za Matokeo ya Sekondari
1. Emergence of adverse events (Safety and tolerability) [36 weeks]
2. Following of the Polymyalgia Rheumatica Activity score [36 weeks]
3. Medical resource evaluation [36 weeks]
4. Following of the cumulative dosages of Glucocorticoids [24 weeks]
5. The flare of the Polymyalgia Rheumatica [36 weeks]
6. Following of the medical exam using the ultrasound Scoring [12 weeks]
7. Evaluation of FDG uptake using TEP-scanner in RegiOns of Interest [12 weeks]
8. Following the proportion of patients relapse [36 weeks]
9. Biological markers [36 weeks]
10. Following of the quality of life [36 weeks]
11. Following of the quality of life [36 weeks]
12. Following of the quality of life [36 weeks]