Comparative Effectiveness of Targeted Therapy in RA Patients

Hanyang University

Status: Enrolling

Conditions: Rheumatoid Arthritis

Treatments: Drug: Adalimuab, Etanercept, Tocilizumab, or Abatacept; Drug: Tofacitinib or Baricitinib

Study type: Observational

Funder types: Other

Identifiers

NCT04449224

HUHRD-SPE-20-01

Details and patient eligibility

About

The objective of a multicenter prospective observational study is to compare effectiveness and safety of biologic disease-modifying antirheumatic drugs and small molecular inhibitors in patients with moderately to severely active rheumatoid arthritis patients who have had an inadequate response or intolerace to methotrexate.

Full description

This study is a multicenter prospective observational study to show non-inferiority of clinical efficacy for small molecular inhibitors after 48 week of treatment to biologic disease modifying anti-rheumatic drugs (bDMARDs) in patients having moderately to severely active RA and who have been intolerant to conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs) including methotrexate.

Primary end point is a percentage of participants of achieving low disease activity according to Disease Activity Score in 28 joints-Erythrocyte Sedientation Rate (DAS28-ESR) at weeks 24. A total of 506 RA patients will be included, and allocated in ratio of 1:1 to bDMARD group and small molecule inhibitor group. Group allocation is determined by shared-decision making, so that the number of participants could be re-assessed according to recruitment status of participatns.

Enrollment: 506 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients are included in this study if they are:

• 19 years or olders
• 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
• Patients having moderately to severely active RA who are intolerant to csDMARDs including methotrexate and those who have never been exposed to bDMARDs or small molecular inhibitors before
• Patients who provide written consent to participate in this study

Exclusion criteria

• Patients who are contraindicated to bDMARDs or small molecule inhibitor
• Patients who have plans for pregnancy or elective surgery
• Patients who had ever diagnosed with any malignancy or are treated for malginancy
• Patients who cannot voluntarily provie a written consent to participate in this study
• Patients who did not provide a written consent to participate in this study

Trial design

506 participants in 2 patient groups

RA patients who start bDMARD

Description:

The efficacy and safety of targeted therapy will be evaluated in RA patients who are treated with a biologic disease modifying antirheumatic drug (bDMARD) including Adalimuab, Etanercept, Tocilizumab or Abatacept after shared-decision making.

Treatment:

Drug: Adalimuab, Etanercept, Tocilizumab, or Abatacept

RA patients who start small molecule inhibitor

Description:

The efficacy and safety of targeted therapy will be evaluated in RA patients who are treated with a small molecular inhibitor including Tofacitinib or Baricitinib after shared-decision making.

Treatment:

Drug: Tofacitinib or Baricitinib