Effect of TNF-blocker Injections Spacing on Rheumatoid Arthritis Inflammatory Activity in Patients in Clinical Remission or Low Disease Activity
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- RA inflammatory activity over 18 months based on repeated DAS28 measures
研究概览
简要总结
Remission is nowadays the recommended therapeutic objective in rheumatoid arthritis. Once this objective is achieved thanks to TNF-blockers, the optimal therapeutic strategy remains unclear, either therapeutic maintenance or progressive DMARD tapering (with a non quantified risk of disease flare).
STRASS is a 2-arm randomized controlled trial aiming to compare these 2 strategies (DMARD maintenance or progressive spacing of TNF-blocker injections) in terms of remission maintenance, relapse risk, safety issues and economic consequences during 18 months.
The inclusion period is 18 months, between September 2008 and February 2010.
详细描述
Rationale:
Clinical remission is the therapeutic objective in rheumatoid arthritis, as recommended by professional practice guidelines. Once this objective is achieved with subcutaneous TNF-blockers, the maintenance of such treatments - highly efficacious but expensive and potentially toxic - is debated. To date, no reliable data are available to estimate the risk - benefice ratio associated with either their maintenance or their tapering.
Objectives:
In RA patients in remission, the study aims:
- To compare RA inflammatory activity based on repeated measures of the Disease Activity Score (DAS) depending on 2 therapeutic schemes: (M) maintenance of unchanged TNF-blockers or (S) tapering of TNF-blocker doses by progressive spacing of subcutaneous injections according to a predefined algorithm;
- To estimate the cost - effectiveness ratio of TNF-blocker spacing as compared to TNF-blocker maintenance.
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
- Single (Participant)
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
- •Patients aged 18 or more, diagnosed with RA according to the 1987 ACR classification criteria;
- •RA treated with subcutaneous TNF-blockers (étanercept or adalimumab) at stable and standard dosage for 1 year or more, as monotherapy or associated with stable conventional DMARD;
- •RA in clinical remission, defined as a stable DAS28 ≤ 2.6 for 6 months or more, without any structural damage progression on X-rays (local reading by the treating rheumatologist);
排除标准
- •Treatment with steroids;
- •progressing disease on X-rays during the year preceding the trial;
- •surgery planed in the 18 coming months;
- •pregnancy;
- •on-going neoplastic disease;
- •other auto-immune disorders different from RA;
- •inability to speak or understand French;
- •absence of signed informed consent;
- •absence of medical insurance coverage.
研究组 & 干预措施
1-M : Maintenance
Usual care
干预措施: DMARD maintenance (Drug)
2 -S : Spacing of TNF-blocker injections
Spacing of TNF-blocker injections
干预措施: progressive spacing of TNF-blocker injections (Drug)
结局指标
主要结局
RA inflammatory activity over 18 months based on repeated DAS28 measures
时间窗: over 18 months
次要结局
- RA inflammatory activity over 18 months estimated by DAS44 repeated measures(over 18 months)
- Cost - Effectiveness ratio calculated as: (CostMaintenance - CostSpacing) / (EfficacyMaintenance - EfficacySpacing);(during the study)
- Relapse rate over 18 months based on Kaplan Meier survival analysis(over 18 months)
- Functional impairment based on HAQ index(during the study)
- Health-related quality of life on SF-36(during the study)
- Utility based on EQ-5D instrument(during the study)
- Structural damage progression over 18 months assessed with the van der HEIJDE-modified Sharp score (SHS)(over 18 months)
- Determinants of maintained remission or relapse after TNF-blocker injection spacing(during teh study)