2023-509788-25-00招募中4 期
JAK inhibitor dose TAPering strategy study in low disease activity rheumatoid arthritis patients
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 308
- 试验地点
- 20
- 主要终点
- the proportion of patients still receiving a JAK-inhibitor and being in CDAI low disease activity at 12 months.
研究概览
简要总结
to compare a dose-tapering strategy versus therapy continuation in rheumatoid arthritis patients in low disease activity treated with JAK inhibitors on the risk of losing low disease activity despite rescue therapy at 12 months
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 18 years at baseline
- •Rheumatoid arthritis defined by the ACR/EULAR criteria.
- •Treated with a JAK inhibitor, full dose for at least 6 months.
- •The JAK inhibitor is prescribed as monotherapy or combined with a csDMARD with a stable dosage for at least 3 months before inclusion.
- •Being in LDA (CDAI≤10) for at least 6 months.
- •With a CRP level below the laboratory standard within the month before the inclusion visit.
- •Women of childbearing potential (WCBP) must have a negative pregnancy test before starting study
排除标准
- •Concomitant disease needing to be treated by the JAK inhibitor at full-dose (for example inflammatory bowel disease).
- •Fibromyalgia according to the physician’s opinion.
- •Anticipated poor compliance with the strategy.
- •Patient with any condition that would prevent participation in the study and completion of the study procedures, including language limitation.
- •Alcohol and/or drug misuse as determined by the investigator.
- •Pregnancy or breastfeeding.
- •Non-affiliation to the French Social Security System.
- •Patient unwilling to sign the informed consent form
- •Patient under legal protection.
- •Patient with a history of JAK-inhibitor dose reduction/spacing before enrollment in the study with the JAK-inhibitor currently being taken.
- •Evidence of flare-up within the last 6 months prior to the inclusion.
- •Patient who received glucocorticoids > 5mg/day in the 3 months prior the inclusion because of the disease activity of the RA.
- •Patient requiring corticoid joint injections in the 3 months prior to inclusion or with scheduled joint injections, to control disease activity.
- •Patient at risk for complication according to the ANSM (current or past smokers, patients at risk of VTE, cancer or major cardiovascular problems, aged ≥ 65 years) at baseline AND currently taking baricitinib or filgotinib.
- •Patient taking associated bDMARD (including anti-TNF, anti-IL6, anti-CD20, abatacept, anti-IL17, anti-IL12/23, anti-IL23, anti-IL1, anti-BAFF, anti-IL5 pathways).
- •Patient taking immunotherapy for neoplasia.
- •Surgery scheduled in the next 12 months.
结局指标
主要结局
the proportion of patients still receiving a JAK-inhibitor and being in CDAI low disease activity at 12 months.
the proportion of patients still receiving a JAK-inhibitor and being in CDAI low disease activity at 12 months.
次要结局
- Disease activity over time assessed by CDAI, SDAI and DAS28 scores.
- The delay between the inclusion visit and the first flare diagnosed by a physician. Two definitions of flare will be assessed for this criterion: • A flare defined by a CDAI > 10 at any visit. • A major flare at any visit, based on the OMERACT definition which is: o An increase in the DAS28-ESR score of more than 1.2 compared to baseline score, o OR a DAS28-ESR score increase of more than 0.6 compared to the baseline score AND the current DAS28-ESR score being above 3.2.
- The 12-month cumulative glucocorticoid dose including rescue short course of glucocorticoids and glucocorticoid joint injections.
- Patient reported outcomes over 12 months including: • Pain assessed by a visual analogic scale of pain (VAS); • Function assessed by the Health Assessment Questionnaire (HAQ); • Flares according to the patient, assessed by the FLARE questionnaire • Fatigue assessed by a visual analogic scale of fatigue and the FACIT-F questionnaire • Quality of life assessed by the EQ-5D-5L and the RAID.
- The modified van der Heijde Total Sharp Score variation between baseline visit and 12-month visit.
- The number of adverse events and severe adverse events at 12 months.
- The number and percentage of patients in CDAI low disease activity at 12 months who could reduce the JAK inhibitor dosage in the dose-tapering arm.
- Incremental cost-utility and cost-effectiveness ratios (ICUR and ICER) from the collective perspective expressed in terms of cost per QALY for the ICUR and cost per patient without major flares for the ICER, at 12 months.
- Occupation, level of income and level of education will be recorded to test the impact of socioeconomic characteristics on care costs and efficiency at 12 months.
研究者
principal investigator
Scientific
Centre Hospitalier Universitaire De Toulouse
研究点 (20)
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