Korean intensive management of early rheumatoid arthritis (KIMERA trial)

Yonsei University0 个研究点目标入组 200 人开始时间: 待定最近更新: 2019年3月11日

试验速览

暂无简介。

•5.1.1 Fullfilment of American College of Rheumatology criteria for the diagnosis of rheumatoid arthritis
•* Criteria (requires at least 4 of the followings)
•Morning stiffness ()
•Arthritis of three or more joint areas()
•Arthritis of hand joints()
•Symmetric arthritis()
•Rheumatoid nodules()
•Serum rheumatoid factor()
•Radiologic changes()
•5.1.2. Duration of symptom less than one year
•5.1.3. Age over 18 years
•5.1.4. Active disease status
•5.1.4.1. Number of swollen joint should be more than 6 out of 66 joints
•5.1.4.2. Number of tender joint should be more than 6 out of 68 joints
•5.1.4.3. ESR > 28 mm/hour or CRP > 1.0 mg/dl
•5.1.4.4. Functional class should be in the range of I to III

•5.2.1. Previous use of DMARDs
•5.2.2. Chronic inflammatory diseases
•: systemic lupus erythematosus, inflammatory myopathy, systemic sclerosis, vasculitis, spondyloarthritis, crystal induced arthritis
•5.2.3. Other systemic illness
•: Malignancy in last 5 years
•Severe cardiopulmonary, gastrointestinal, endocrinologic, hematologic, neurologic
•Major trauma or surgery in last 8 weeks
•Current pregnancy or having a chance to be pregnant
•Infection (body temperature = 38 °C, HBsAg (+), anti-HCV (+), active tuberculosis)
•5.2.4. laboratory tests
•WBC < 3,000 /mm3, neutrophil < 1,200 /mm3
•Hb < 9 mg/dL, Platelete < 10,000 /mm3
•AST > 68 IU/L, ALT > 92 IU/L, T.bili > 2.4 mg/dL, Cr > 1.4 mg/dL

发起方