A Multi-center Cross-sectional Study on Treatment Patterns and Patient Characteristics in Rheumatoid Arthritis (RA) Patients Treated by Biological DMARDs in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 808
- 试验地点
- 15
- 主要终点
- Number of Participants Receiving Biological Agent as Monotherapy or in Combination With Conventional Synthesis Disease-modifying Anti-rheumatic Drugs (csDMARDs) Therapy
研究概览
简要总结
This observational study will describe the treatment patterns of usage of biological DMARDs in routine clinical practice and the demographics and RA disease characteristics in patients suffering from rheumatoid arthritis. Patients will be recruited and examined the same day when recruited. There will be no follow up visit or treatment period only one visit in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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 at least 18 years of age.
- •Patients with a diagnosis of RA according to the revised ACR criteria.
- •Patients receiving treatment of launched biological DMARDs.
排除标准
- •Patients who received biological DMARDs due to clinical trials or biologics not launched.
- •Patients who are considered not appropriate for study due to other reasons at physicians' discretion.
结局指标
主要结局
Number of Participants Receiving Biological Agent as Monotherapy or in Combination With Conventional Synthesis Disease-modifying Anti-rheumatic Drugs (csDMARDs) Therapy
时间窗: Day 1 (enrollment visit)
Biological agent monotherapy meant participants using a biological agent without concomitant csDMARDs. Biological agent monotherapy included biological agent only, biological agent + glucocorticoid, biological agent + non-steroidal anti-inflammatory drugs \[NSAIDs\], and biological agent + glucocorticoid + NSAIDs.
Number of Participants Receiving a Biological Agent Concomitant With Other Drugs
时间窗: Day 1 (enrollment visit)
Number of participants receiving treatment of a biological agent concomitant with the following drugs: glucocorticoid, NSAIDs, other external medicine, or concomitant glucocorticoid and concomitant NSAIDs. The same participant could use 2 or 3 of concomitant glucocorticoid, NSAIDs and other external medicine.
Number of Participants Receiving a Biological Agent as Monotherapy by Types of Biological Agents
时间窗: Day 1 (enrollment visit)
Number of participants who received a biological agent as monotherapy is presented by biological agent (adalimumab, tocilizumab, etanercept, and infliximab).
Average Weekly Dose of Treatment for Each Biological Agent
时间窗: Day 1 (enrollment visit)
Average weekly dose of treatment of each biological agent (adalimumab, tocilizumab, etanercept, or infliximab) is presented.
Average Duration of Treatment for Each Biological Agent
时间窗: Day 1 (enrollment visit)
Average duration of treatment of each biological agent (adalimumab, tocilizumab, etanercept, or infliximab) is presented.
Number of Participants With Previous Use of the Same Biological Agent
时间窗: Day 1 (enrollment visit)
Participants who used the same biological agent in the past and were using that same biological agent at the time of study enrollment.
Number of Participants With Reasons for Switching Types of Biological Agent Who Used a Different Biological Agent in the Past
时间窗: Day 1 (enrollment visit)
Participants who used a different biological agent in the past and switched are shown by reason for switching. One participant could have switched types of biological agent due to multiple reasons.
Average Weekly Dose of Each Concomitant Glucocorticoid
时间窗: Day 1 (enrollment visit)
Average weekly dose of each concomitant glucocorticoid (prednisone acetate, oral; betamethasone \[BMZ\] dipropionate and betamethasone sodium phosphate, intra-articular (IA) injection; and methylprednisolone, intravenous drip infusion, oral) is presented.
Average Duration of Treatment With Each Concomitant External Medicine
时间窗: Day 1 (enrollment visit)
Number of Participants Using One, Two, or Three (or More) Concomitant csDMARDs
时间窗: Day 1 (enrollment visit)
Number of participants using one concomitant csDMARD, two concomitant csDMARDs (methotrexate + hydroxychloroquine \[HCQ\], methotrexate + salazosulfapyridine \[SASP\], methotrexate+ leflunomide, SASP + HCQ, and other combinations), or three (or more) concomitant csDMARDs (methotrexate + SASP + HCQ, and other combinations) are presented.
Average Weekly Dose of Each Concomitant csDMARD
时间窗: Day 1 (enrollment visit)
One participant could have received multiple concomitant csDMARDs treatment.
Average Duration of Treatment With Each Concomitant csDMARD
时间窗: Day 1 (enrollment visit)
One participant could have received multiple concomitant csDMARDs treatment.
Average Daily Dose of Each Currently Concomitant NSAIDs
时间窗: Day 1 (enrollment visit)
One participant could have received multiple concomitant NSAIDs treatment.
Average Daily Dose of Each Previously Concomitant NSAIDs
时间窗: Day 1 (enrollment visit)
One participant could have received multiple concomitant NSAIDs treatment.
次要结局
- Number Participants With Past Medical History of Concurrent Chronic Disease, Tuberculosis, Hepatitis, and Imaging Manifestations of Joint Damage(Day 1 (enrollment visit))
- Weight(Day 1 (enrollment visit))
- Height(Day 1 (enrollment visit))
- Number of RA Related Operations(Day 1 (enrollment visit))
- RA Duration Since Diagnosis(Day 1 (enrollment visit))
- Number of Participants With RA Duration(Day 1 (enrollment visit))
- Number of Participants With Concurrent RA Extra-articular Symptoms(Day 1 (enrollment visit))
- Number of Participants With Concurrent Interstitial Lung Disease Using Methotrexate(Day 1 (enrollment visit))
- C-Reactive Protein (CRP) Values(Day 1 (enrollment visit))
- Number of Participants With Abnormal CRP Values(Day 1 (enrollment visit))
- Erythrocyte Sedimentation Rate (ESR) Values(Day 1 (enrollment visit))
- Number of Participants With Abnormal ESR Values(Day 1 (enrollment visit))
- Hemoglobin Values(Day 1 (enrollment visit))
- Number of Participants With Anemia(Day 1 (enrollment visit))
- Number of Participants With Positive Anti-cyclic Citrullinated Peptide (ACCP) Antibody(Day 1 (enrollment visit))
- Number of Participants With Positive Rheumatoid Factor (RF)(Day 1 (enrollment visit))
- Triglyceride Values(Day 1 (enrollment visit))
- Number of Participants With Abnormal Triglyceride Values(Day 1 (enrollment visit))
- Total Cholesterol Values(Day 1 (enrollment visit))
- Number of Participants With Abnormal Total Cholesterol Values(Day 1 (enrollment visit))
- Swollen Joint Count (SJC)(Day 1 (enrollment visit))
- Tender Joint Count (TJC)(Day 1 (enrollment visit))
- Disease Activity Score Based on 28-Joint Count (DAS28)(Day 1 (enrollment visit))
- Number of Participants Experiencing High Disease Activity to Clinical Remission Using the DAS28(Day 1 (enrollment visit))
- Clinical Disease Activity Index (CDAI) Scores(Day 1 (enrollment visit))
- Number of Participants Experiencing High Disease Activity to Clinical Remission Using the CDAI(Day 1 (enrollment visit))
- Simplified Disease Activity Index (SDAI)(Day 1 (enrollment visit))
- Number of Participants Experiencing High Disease Activity to Clinical Remission Using the SDAI(Day 1 (enrollment visit))
- Number of Participants With Duration of Treatment of Biological Agent(Day 1 (enrollment visit))
- DAS28 by Duration of Treatment of Biological Agent(Day 1 (enrollment visit))
- DAS28 by Biological Agent as Monotherapy or Combination With csDMARDs(Day 1 (enrollment visit))
- Physician's Global Assessment (PGA) of Disease Activity(Day 1 (enrollment visit))
- Patient's Global Assessment (PtGA) of Disease Activity(Day 1 (enrollment visit))
- Health Assessment Questionnaire-Disability Index (HAQ-DI) Score(Day 1 (enrollment visit))
- Participant's Fatigue Assessment(Day 1 (enrollment visit))
- Participant's Pain Assessment(Day 1 (enrollment visit))