BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica (BACHELOR Study)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 8
- 主要终点
- Following of the Polymyalgia Rheumatica Activity score
研究概览
简要总结
Patients with recent PMR(6 months or less) with a PMR-AS >17 and no oral or parenteral GCs during the past 2 weeks (at least) will be included.
Treatment with oral baricitinib 4mg or placebo during 12 weeks and then, if PMR-AS≤10, they will receive baricitinib 2 mg for 12 weeks and then will stop treatment.
No rescue is allowed before week 4 (visit 3) but patients may receive up to 2 intra-articular or soft tissue injections of GCs until week 4 according to investigator's opinion.
From week 4 to week 12, steroids will be proposed as a rescue for both arms at investigators' discretion and according to PMR-AS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Experimental 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.
干预措施: Baricitinib (Drug)
Control group
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.
干预措施: Placebos (Drug)
结局指标
主要结局
Following of the Polymyalgia Rheumatica Activity score
时间窗: 12 weeks
The activity of Polymyalgia Rheumatica is evaluated using the Polymyalgia Rheumatica Activity score (PMR-AS), a disease activity score based on morning stiffness, ability to elevate the upper limbs, physician's global disease assessment , Visual Analog Score for patient's pain (VAS), and CRP level. The PMR-AS is considered as relevant to define relapse and remission but also to decide if treatment have to be decreased, unchanged or increased (PMR-AS \< 10: decrease, PMR-AS \> 17 increase to previous dosage, 10 ≤ PMR-AS ≤ 17: stable dose)
次要结局
- Following of the Polymyalgia Rheumatica Activity score(36 weeks)
- Emergence of adverse events (Safety and tolerability)(36 weeks)
- ultrasound of synovitis and tenosynovitis(24 weeks)
- Level of biological markers(24 weeks)
- Following of the cumulative dosages of Glucocorticoids(36 weeks)
- Following of the quality of life(36 weeks)