None listed
Conditions
Interventions
None listed
Sponsors
Hanyang University Seoul Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are included in this study if they are: 1) 19 years or olders 2) Patients who satisfy the 1987 American College of Rheumatology (ACR) or 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for RA 3) Patients having moderately to severely active RA who are intolerant to csDMARDs including methotrexate and those who have never benn exposed to bDMARDs or small molecular inhibitors before. 4) Patients who provide written consent to participate in this study
Exclusion criteria
Exclusion criteria: Patients were excluded from the study if they are: 1) Patients who are contraindicated to bDMARDs or small molecule inhibitor 2) Patients who have plans for pregnancy or elective surgery 3) Patients who had ever diagnosed with any malignancy or are treated for malginancy 4) Patients who cannot voluntarily provie a written consent to participate in this study 5) Patients who did not provide a written consent to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants achieving low disease activity according to Disease Activity Score 28 joints-Erythrocyte sedimentation (DAS28-ESR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in patient-reported outcomes including Health Assessment Questionnaire (HAQ) and EuroQol-5 dimension (EQ-5D);Percentage of participants achieving low disease activity according to Disease Activity Score 28 joints-Erythrocyte sedimentation rate (DAS28-ESR);Percentage of participants achieving remission according to Disease Activity Score 28 joints-Erythrocyte sedimentation rate (DAS28-ESR);Percentage of participants with European League Against Rheumatism (EULAR) Response according to Disease Activity Score 28 joints-Erythrocyte sedimentation rate (DAS28-ESR); The EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline >1.2 with a DAS28 score =3.2; moderate responders had a change from baseline >1.2 with a DAS28 score >3.2 or a change from baseline >0.6 to =1.2 with a DAS28 score =5.1. Participants with change from baseline >0.6 to =1.2 with a DAS28 score >5.1, or any score with change from baseline =0.6, were assessed as non-responders.;Presence of radiologic progression in rheumatoid arthritis (if possible);Changes from baseline in ultrasonographic findings of rheumatoid arthritis (if possible);Changes from baseline in biomarkers (if possible);Incidence of adverse events (AEs) or serious adverse events (SAEs) of targeted therapy (if possible);Compliance with targeted therapy defined by Patient-reported adherence and Modified Morisky scale (if possible) | — |
Countries
Korea, Republic of
Contacts
Public ContactHyoungyoung Kim
Hanyang University Seoul Hospital
Outcome results
None listed