Design and Evaluation of an Individualized Biodrug Tapering Strategy Based on Biodrug Dosage: the MONITORA Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 8
- 主要终点
- Rheumatoid arthritis flare-up
研究概览
简要总结
Rheumatoid arthritis (RA) is the most common inflammatory joint disorder. Since twenty year and the use of synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and biological (b)DMARD, remission can be reached. When remission is obtained, the physician has no recommendations for managing a step-down, and future guidelines will be useful to assist the clinician. Recent data suggest that tapering is feasible, but with high risk of flares. Flares are less frequent when bDMARD blood concentration is high. But, the optimal adalimumab concentration to keep before a step of tapering no targeting personal is unknown.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient over 18 years of age
- •Patients with a diagnosis of RA according to ACR/EULAR 2010 criteria
- •Remission according to DAS28<=2.6 for at least 6 months
- •Patient treated with ADA for at least 6 months. The patient is treated according to one of the following two strategies:
- •ADA 40 mg every two weeks (= every 14 days) according to the standard regimen
- •or ADA 40 mg every 3 weeks (= every 21 days)
- •A negative highly sensitive pregnancy test for women of Childbearing Potential*
- •Affiliated person or beneficiary of a social security scheme
- •Informed consent signed by the patient after information
排除标准
- •Incapacity or refusal to understand and / or sign informed consent to participate in the study.
- •Existing pregnancy, lactation, or intended pregnancy within the next 15 months
- •Fibromyalgia associated to RA
- •Any dose of prednisone for RA treatment 6 months before inclusion
- •Patient deprived of liberty or patient under guardianship or curator ship.
研究组 & 干预措施
Single arm trial
Single arm trial in patients with established RA who achieved clinical remission with subcutaneous injection of adalimumab in combination with MTX (methotrexate). Patients will undergo a tapering strategy based only on the clinical status (flare /no flare) during 12 months.
干预措施: Clinical tapering strategy (Drug)
Optimized tapering adalimumab
An optimized tapering adalimumab strategy based on the disease activity and the adalimumab trough concentration. The tapering strategy will rely on the adalimumab trough concentration. Spacing will be performed only if adalimumab trough concentration is above the pre-specified concentration threshold
干预措施: Step Wedge trial (Drug)
结局指标
主要结局
Rheumatoid arthritis flare-up
时间窗: 15 Months
The RA flare-up will be defined as previously by: 1. a disease activity score (DAS)28 that increase above 2.6 for patient previously in remission (DAS28≤2.6) and a DAS28 increase (ΔDAS28) of 0.6 or greater for patients with low disease activity (2.6\<DAS28\<3.2) : YES/NO 2. Use of a glucocorticoid for the symptoms of RA, regarless of the DAS28 : YES/NO DAS28 is calculated according to the formula that is composed of the number of tender joints (TJC) and swollen joints (SJC), patient's global assessment of disease activity on a visual analogue scale (PGA, 0-10), and C-reactive protein (CRP). Formula for calculating DAS28 using C-reactive protein (CRP) : DAS28-CRP=(0.56 × √TJC) + (0.28 × √SJC) + (0.014 × PGA \[mm\]) + (0.36 × ln(CRP in mg/L+1) + 0.96,
次要结局
- Infection(15 months)