Comparative Effectiveness of Targeted Therapy in RA Patients

Sponsor
Hanyang University
Study ID
NCT04449224
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adalimuab, Etanercept, Tocilizumab, or Abatacept — 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.
  • Tofacitinib or Baricitinib — 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.

Study Details

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.

Key Dates

Start date
Apr 27, 2020
Status verified
Jun 2020
Primary completion
Aug 19, 2023
Completion
Aug 19, 2024

Study Design

Enrollment
506 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Percentage of participants achieving low disease activity according to Disease Activity Score 28 joints-Erythrocyte sedimentation (DAS28-ESR) [ Time Frame: At weeks 24 ]

Central Contacts

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