Comparative effectiveness of biologic disease-modifying antirheumatic drugs and small molecular inhibitors in patients with moderate to severe RA: Prospective observational study

Not Applicable

Recruiting

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

• Registration Number: KCT0005016
• Lead Sponsor: Hanyang University Seoul Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 18 May 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 506

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

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

Study & Design

• Study Type: Observational Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of participants achieving low disease activity according to Disease Activity Score 28 joints-Erythrocyte sedimentation (DAS28-ESR)