NCT04449224

Comparative Effectiveness of Targeted Therapy in RA Patients

Comparative Effectiveness of Biologic Disease-modifying Antirheumatic Drugs and Small Molecular Inhibitors in Patients With Moderate to Severe RA: Prospective Observational Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 506 (estimated)
• Sponsor: Hanyang University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.
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.

Timeline

• Start date: 2020-04-27
• Primary completion: 2023-08-19
• Completion: 2024-08-19
• First posted: 2020-06-26
• Last updated: 2020-06-26

Locations

1 site across 1 country: South Korea