Comparative effectiveness of biologic disease-modifying antirheumatic drug or targeted synthetic disease-modifying antirheumatic drug tapering in RA patients of low disease activity

Not Applicable

Conditions: Diseases of the musculo-skeletal system and connective tissue

Registration Number: KCT0005009

Lead Sponsor: Chonnam National University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 455

Inclusion Criteria

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.

Exclusion Criteria

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 (+)

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of participants with Low disease activity

Secondary Outcome Measures

Name	Time	Method
disease activity score (DAS) 28 score;tender joint count /swollen joint count (68 joints);erythrocyte sedimentation rate/C-Reactive Protein (ESR/CRP);proportion of ACR/EULAR (American College of Rheumatology/European League against Rheumatism ) remision;Simple Disease Activity Index/Visual Analog Scale/Health assessment questionnaire disability index (SDAI/VAS/HAQ-DI);adverse events