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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0005009

Enrollment

455

Registered

2020-05-12

Start date

2020-06-01

Completion date

Unknown

Last updated

2020-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : At the time of patient registration, the RA patients with low disease activity evaluated by DAS28-ESR were randomly assigned to one of two groups (dose-reduction group and dose-maintaining grou

at the time of registration and if low disease activity is maintained at 3 months after dose reduction, the administration interval is increased by 50&#37

. In the case of small molecule inhibitors, the dose is reduced by 50&#37

at registration and will be maintained until after 6 months. The dose-maintaining group will continue a standardised treat-to-target treatment protocol, and treatment will be continued at the same do

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 (+)

Design outcomes

Primary

Measure	Time frame
Proportion of participants with Low disease activity	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactDong-Jin Park

Chonnam National University Hospital

Outcome results