Efficacy and Safety of Tofacitinib (TF) Combined With Iguratimod(IGU) in the Treatment of Moderate to Severe Active Rheumatoid Arthritis (RA)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The percentage of patients who achieve clinical remission at week 30 using European League Against Rheumatism (EULAR) response criteria DAS28
研究概览
简要总结
RA is a common autoimmune disease that causes joint damage.It is necessary to reach the standard as soon as possible and give effective drugs according to the patient's disease activity to avoid disability. Tofacitinib(TF) is a new type of oral tyrosine kinase inhibitor (JAKi) for the treatment of moderate to severe active RA. However, there is alack of Chinese data on the joint scheme, long-term use, maintenance and stop of TF in the real world. We will use the new JAK combination regimen to treat RA patients, and carry out long-term clinical follow-up for 30 weeks.
详细描述
Objective
To observe the clinical efficacy and safety of TF combined with/ without IGU for 30 weeks in patients with moderate to severe active RA with different clinical characteristics and subgroups by using a prospective cohort , and to find the best combination scheme of TF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet the following inclusion criteria will be eligible to participate in the study:
- •Patients who meet RA standards in 1987 and 2010 or ERA standards in 2012;
- •Age > 18 years old;
- •the extrapulmonary manifestations of RA were stable;
- •Patients with NSAIDs tolerance;
- •DAS28-ESR is highergreater than 2.6.
排除标准
- •Patients who meet any of the following criteria will be excluded from the study:
- •Patients with acute and chronic infection;
- •Platelet count < 80*10^9/L, or white blood cell < 3*10^9/L;
- •ALT or AST is 2 times higher than the upper limit of normal value;
- •Renal insufficiency: serum Cr ≥ 176 umol/L;
- •Pregnant or lactating women (breastfeeding);
- •Have a history of malignant tumor (the cure time is less than 5 years);
- •Patients with severe hypertension and cardiac insufficiency;
- •Other diseases or conditions in which immune suppressants cannot be used;
- •People who are allergic to TF.
研究组 & 干预措施
Tofacitinib (TF)+Iguratimod (IGU)
Drug: Iguratimod（IGU），25mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response.
Drug: Tofacitinib（TF），5mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response.
Drug: Prednisone （Pred）： 0-10mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response.
干预措施: Iguratimod (Drug)
Tofacitinib (TF)+Iguratimod (IGU)
Drug: Iguratimod（IGU），25mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response.
Drug: Tofacitinib（TF），5mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response.
Drug: Prednisone （Pred）： 0-10mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response.
干预措施: Tofacitinib (Drug)
Tofacitinib (TF)+Iguratimod (IGU)
Drug: Iguratimod（IGU），25mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response.
Drug: Tofacitinib（TF），5mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response.
Drug: Prednisone （Pred）： 0-10mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response.
干预措施: Pred (Drug)
Tofacitinib (TF)
Drug: Tofacitinib（TF），5mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response.
Drug: Prednisone （Pred）： 0-10mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response.
干预措施: Tofacitinib (Drug)
Tofacitinib (TF)
Drug: Tofacitinib（TF），5mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response.
Drug: Prednisone （Pred）： 0-10mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response.
干预措施: Pred (Drug)
结局指标
主要结局
The percentage of patients who achieve clinical remission at week 30 using European League Against Rheumatism (EULAR) response criteria DAS28
时间窗: week 30
The percentage of patients whose Disease Activity Score in 28 Joints (DAS28) achieve remission（DAS28-ESR≤ 2.6）and Low Disease Activity (DAS28-ESR ≤ 3.2). The DAS28 is a composite score derived from 4 of these measures，that is the count of tender joint count（TJC, 0-28）and swollen joint count（SJC, 0-28）, measure erythrocyte sedimentation rate (ESR, mm/h) or C reactive protein (CRP, mg/L) and to make a patient assessment of disease activity i.e. 'global assessment of health' (GH) using a 100 mm visual analogue scale (VAS) with 0 = best, 100 = worst. DAS28 values were calculated as follows: DAS28- ESR = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 x GH. High disease activity: DAS28-ESR \> 5.1; Moderate disease activity: 5.1≥ DAS28 \> 3.2 to 5.1; Low disease activity (LDA) and Remission mean Clinical remission.
次要结局
- The percentage of patients who achieve clinical remission using DAS28-ESR at week 6(week 6)
- Percentage of Disease Activity Score 28 (DAS28) -ESR Criteria Responders at week 6(week 6)
- Change from baseline Simplified Disease Activity Index (SDAI)(up to week 30)
- The percentage of patients who achieve clinical remission using DAS28-ESR at week 18(week 18)
- Percentage of Disease Activity Score 28 (DAS28) -ESR Criteria Responders at week 30(week 30)
- Percentage of Disease Activity Score 28 (DAS28) -ESR Criteria Responders at week 18(week 18)
- Percentage of participants achieving ACR/EULAR remission at week 30(week 30)
- Percentage of participants achieving ACR/EULAR remission at week 18(week 18)
- Percentage of participants achieving ACR/EULAR remission at week 6(week 6)
- Change from baseline Clinical Disease Activity Index (CDAI)(up to week 30)
- Change From Baseline in Erythrocyte Sedimentation Rate (ESR)(up to week 30)
- Change from baseline Health Assessment Questionnaire Disability Index (HAQ-DI)(up to week 30)
- Number of participants with"adverse events (AEs)"(up to week 30)
- Change From Baseline in C-reactive Protein (CRP)(up to week 30)
- Percentage of American College of Rheumatology [ACR] 20 Criteria Responders every time(up to week 30)
- Incidence of participant withdrawal(up to week 30)
研究者
Qiang Shu
Chief Physician
Qilu Hospital of Shandong University