Comparative Effectiveness of Targeted Therapy in RA Patients

NCT ID: NCT04449224

Last Updated: 2020-06-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 506 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-27
• Study Completion Date: 2024-08-19

Brief Summary

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.

Detailed 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.

Conditions

Rheumatoid Arthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

RA patients who start bDMARD

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.

Adalimuab, Etanercept, Tocilizumab, or Abatacept

Intervention Type: DRUG

A specific targeted therapy wil be decided by shared-decision making, a bidirectional process in which clinicians and patients make decisions based on clinical evidence that balances risks and expected outcomes with patient preferences and values.

RA patients who start small molecule inhibitor

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.

Tofacitinib or Baricitinib

Intervention Type: DRUG

A specific targeted therapy wil be decided by shared-decision making, a bidirectional process in which clinicians and patients make decisions based on clinical evidence that balances risks and expected outcomes with patient preferences and values.

Interventions

Adalimuab, Etanercept, Tocilizumab, or Abatacept

A specific targeted therapy wil be decided by shared-decision making, a bidirectional process in which clinicians and patients make decisions based on clinical evidence that balances risks and expected outcomes with patient preferences and values.

Intervention Type: DRUG

Tofacitinib or Baricitinib

A specific targeted therapy wil be decided by shared-decision making, a bidirectional process in which clinicians and patients make decisions based on clinical evidence that balances risks and expected outcomes with patient preferences and values.

Intervention Type: DRUG

Other Intervention Names

Humira, Enbrel, Etoloche, Eucept, Actemra, or Orencia; Xeljanz or Olumiant

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Republic of Korea

OTHER_GOV

Sponsor Role: collaborator

Hanyang University

OTHER

Sponsor Role: lead

Responsible Party

Yoon-Kyoung Sung

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yoon-Kyoung Sung, MD, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Hanyang University

Locations

Hanyang University

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Yoon-Kyoung Sung, MD, PhD, MPH

Role: CONTACT

sungyk@hanyang.ac.kr

82-2-2290-9250

Facility Contacts

Yoon-Kyoung Sung, MD, PhD, MPH

Role: primary

sungyk@hanyang.ac.kr

82-2-2290-9250

Other Identifiers

HUHRD-SPE-20-01

Identifier Type: -

Identifier Source: org_study_id