A multi-center, open, randomized, 18-month, parallel-group, superiority study to compare the effect of proactive therapeutic drug monitoring versus standard of care with regards to maintenance of sustained disease control without flare in adults with rheumatoid arthritis treated with a subcutaneous tumor necrosis factor inhibitor
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 391
- 试验地点
- 21
- 主要终点
- Sustained disease control over the follow-up period of 18 months without flare, with flare defined as either of the following: A combination of an increase in Disease Activity Score using 28 joints- C-reactive protein (DAS28-CRP) ≥ 1.2, or ≥ 0.6 if DAS28-CRP ≥ 3.2, AND 2 swollen joints on examination of 44 joints Consensus between participant and physician that disease flare has occurred, leading to a major change in treatment
研究概览
简要总结
To assess whether proactive TDM is superior to standard of care in order to maintain sustained disease control without flares in patients with RA treated with SC TNFi.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •A clinical diagnosis of RA
- •≥ 18 and < 75 years of age at screening
- •On stable therapy with standard dose of a SC TNFi (adalimumab) for a minimum of 3 months and a maximum of 24 months
- •In low disease activity or remission (DAS28-CRP < 3.2) and indication for continuation of treatment according to the treating physician
- •Subject capable of understanding and signing an informed consent form
排除标准
- •Major comorbidities, such as previous malignancies within the last 5 years, uncontrolled diabetes mellitus, severe infections (including HIV), uncontrollable hypertension, severe cardiovascular disease (NYHA class 3 or 4), severe respiratory diseases, demyelinating disease, significant chronic widespread pain syndrome, significant renal or hepatic disease, and/or other diseases or conditions which either contraindicate treatment with SC TNFi or make adherence to the protocol difficult
- •Hypersensitivity to SC TNFi (adalimumab)
- •Pregnancy, or subject considering becoming pregnant during the study period
- •Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers, or other factors that makes adherence to the study protocol difficult
- •Changes in csDMARD co-medication, including dose changes of csDMARD or changes in the dose of corticosteroids within the last 2 months
- •Co-medication with bDMARD, tsDMARD, or other immunosuppressive drugs (excluding csDMARD and corticosteroids ≤ 7.5 mg prednisolone (or equivalent) once daily).
- •Active participation in any other interventional study
- •In need of live vaccines during the study period
结局指标
主要结局
Sustained disease control over the follow-up period of 18 months without flare, with flare defined as either of the following: A combination of an increase in Disease Activity Score using 28 joints- C-reactive protein (DAS28-CRP) ≥ 1.2, or ≥ 0.6 if DAS28-CRP ≥ 3.2, AND 2 swollen joints on examination of 44 joints Consensus between participant and physician that disease flare has occurred, leading to a major change in treatment
Sustained disease control over the follow-up period of 18 months without flare, with flare defined as either of the following: A combination of an increase in Disease Activity Score using 28 joints- C-reactive protein (DAS28-CRP) ≥ 1.2, or ≥ 0.6 if DAS28-CRP ≥ 3.2, AND 2 swollen joints on examination of 44 joints Consensus between participant and physician that disease flare has occurred, leading to a major change in treatment
次要结局
- Disease activity at 4, 8, 12, and 18 months
- Time to disease flare
- Number and type of adverse events (AE)
- Drug survival, drug consumption, occurrence of ADAb, serum drug levels
研究者
Silje W Syversen
Scientific
Diakonhjemmet Sykehus AS