Effectiveness and safety study of biologic disease-modifying antirheumatic drug and targeted synthetic disease modifying antirheumatic drug dose reduction strategies in rheumatoid arthritis patients with remission

Chonnam National University Hospital0 个研究点目标入组 455 人开始时间: 待定最近更新: 2020年5月18日

试验速览

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•Subjects are eligible to participate in the study if they meet all of the following criteria:
•1. The subject was provided written consent for participation in the study.
•2. Age =18 years at the time of signing informed consent.
•3. Subjects diagnosed with rheumatoid arthritis (RA) according to the 1987 ACR Classification Criteria or the 2010 American College of Rheumatology/European League against Rheumatism (ACR / EULAR) Classification Criteria
•4. Subjects who have not received the following drugs or who have been using the following drugs in stable doses for at least 28 days prior to baseline: Nonsteroidal anti-inflammatory drugs (NSAIDs; excluding topical preparations), acetaminophen, or oral corticosteroids (= 10 mg / day prednisolone or equivalent).
•5. Patients with remission or low disease activity defined by disease activity score 28 (DAS28) for at least 6 months using at least one biological agent or small molecule inhibitor.

•A participant will not be eligible for inclusion in this study if any of the following criteria apply:
•1. Current or history of other inflammatory arthritis such as SpA, PsA, SLE, Sarcoidosis and uncontrolled fibromyalgia
•2. Baseline assessments:
•Hemoglobin < 9.0 g/dL
•neutrophil count < 1000/µL
•lymphocyte count < 800/µL
•Platelet count < 75000/µL
•ALT = 2 ×ULN
•AST = 2 × ULN
•Total bilirubun level = 1.5 × ULN
•Current or history of renal disease or estimated glomerular filtration rate (eGFR) by
•Modification of Diet in Renal Disease (MDRD) calculation <40 mL/min/1.73m2 at screening.
•Has a positive test for hepatitis B virus (HBV) defined as either:
•HBs Ag (+) or HCV (+)

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