Screening for Flare After Discontinuation of Biological/Targeted Synthetic Disease Modifying Anti-rheumatic Drug (b/tsDMARD) in Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 85
- 主要终点
- Proportion of subjects without a clinical flare until week 24
研究概览
简要总结
To evaluate whether stringent follow-up consisting of combined laboratory and ultrasound surveillance is superior to clinical monitoring alone to maintain clinical remission in rheumatoid arthritis.
详细描述
Randomized, controlled, parallel-group, multi-centre study in which patients with rheumatoid arthritis treated with biological/targeted synthetic disease modifying antirheumatic drug (b/tsDMARD) in mono- or combination therapy with conventional synthetic disease modifying antirheumatic drug (csDMARD) in a stable dosage and interval for ≥6 months with low disease activity or remission will receive an power Doppler musculoskeletal ultrasound examination (PDUS) and monitoring of C-reactive protein (CRP) levels at baseline and several timepoints within a 24 month study period (primary endpoint) and within a 48 month long-term extension. At baseline, b/tsDMARD medication will be withdrawn in all patients, who will be randomized in a 1:1 ratio in an "Assisted monitoring" (arm A) or a "Clinical monitoring" (arm B) arm respectively. Further stratification for remission vs. low disease activity and mono- vs combination therapy will be implemented in the randomisation process. In arm A, CRP and PDUS information will be made available to the clinical assessors who, at each time-point will use this information along with that from clinical examination, to identify patients experiencing recurrence of inflammation which will then be counted as subclinical flare according to predefined criteria. In arm B the results of CRP and PDUS will be recorded but will not be made available to the clinical assessor who will have to identify clinical flares according to predefined criteria based on information from the clinical examination only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
After checking the inclusion- and exclusion criteria and after the patients´ consent the study investigator contacts the administrative office of the coordinating center. The online computerised randomisation algorithm "Randomizer for Clinical Trials by the Medical University of Vienna (MUW) will be used for randomisation for all centres.
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 with rheumatoid arthritis classified by the American College of Rheumatology/European League Against Rheumatism classification criteria
- •biological disease-modifying anti-rheumatic drug (bDMARD) or targeted synthetic disease-modifying anti-rheumatic drug (tsDMARD) treatment in monotherapy or in combination therapy with conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) in a stable dosage and interval for ≥6 months. Previous extension of bDMARD or tsDMARD interval will also be accepted. bDMARDs and tsDMARDs will include all currently available originator and biosimilar compounds, with the exception of rituximab and its biosimilar compounds
- •No swollen joint by 28-joint count at baseline, and screening
- •C-reactive protein of ≤0.5mg/dL at baseline AND history of C-reactive protein >0,5mg/dl related to rheumatoid arthritis activity
- •Clinical disease activity index ≤10
- •Shared decision between patient and physician to attempt b/tsDMARD withdrawal
- •Willing and able to understand and follow the study procedures
- •Written informed consent
- •Female and male subjects aged ≥ 18 years
排除标准
- •History of or current extra-articular manifestation of rheumatoid arthritis, with exception of rheumatoid nodules
- •Systemic glucocorticoid treatment in the past 3 months
- •Intraarticular injection with glucocorticoids in the past 1 month
- •Joint replacement surgery other than total knee or hip arthroplasty or complete joint destruction
- •Power Doppler signal ≥2 in any assessed joint and/or tendon at screening or baseline
结局指标
主要结局
Proportion of subjects without a clinical flare until week 24
时间窗: week 24
Proportion of subjects without a clinical flare
次要结局
- 28 swollen joint count(week 24)
- Time to clinical flare (days)(study period)
- World Health Organization Quality of Life Questionnaire(week 24)
- Evaluator's global assessment(week 24)
- Proportion of subjects with a clinical flare in the assisted monitoring arm vs. clinical monitoring arm, the latter stratified according to b/tsDMARD reinitiation(week 24)
- Proportion of patients in low disease activity or remission based on simplified disease activity index(week 48)
- Radiographic progression(at week 48 weeks from baseline)
- Health Assessment Questionnaire Disability Index(week 24)
- Fatigue(week 24)
- Proportion of subjects without a clinical flare(week 48)
- 28 tender joint count(week 24)
- Patient's global assessment(week 24)
- C-reactive protein(week 24)
- Morning stiffness(week 24)
研究者
Dr. Peter Mandl
Ap. Prof. Priv.-Doz. Dr. Peter Mandl
Medical University of Vienna