Comparative Effectiveness of Targeted Therapy in RA Patients

NCT04449224 | Unknown

• 1 other identifier: HUHRD-SPE-20-01
• Study Type: observational
• Target: 506
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

Arthritis; Arthritis, Rheumatoid; Joint Diseases; Musculoskeletal Diseases

Outcome Measures

Primary Outcomes (1)

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

  Disease Activity Score 28 joints-Erythrocyte sedimentation (DAS28-ESR) below 3.2 indicates low disease activity of RA.

  At weeks 24

Secondary Outcomes (11)

• Changes in Health Assessment Questionnaire (HAQ)

  At weeks 12, 24, and 48

• Changes in EuroQol-5 dimension (EQ-5D)

  At weeks 12, 24, and 48

• Changes in EuroQol visual analogue scale (EQ VAS)

  At weeks 12, 24, and 48

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

  At weeks 12 and 48

• Percentage of participants achieving remission according to Disease Activity Score 28 joints-Erythrocyte sedimentation rate (DAS28-ESR)

  At weeks 12, 24, and 48

Study Arms (2)

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.

Drug: Adalimuab, Etanercept, Tocilizumab, or Abatacept

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.

Drug: Tofacitinib or Baricitinib

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.

Also known as: Humira, Enbrel, Etoloche, Eucept, Actemra, or Orencia

RA patients who start bDMARD

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.

Also known as: Xeljanz or Olumiant

RA patients who start small molecule inhibitor

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Korean RA patients who start biologic disease modifying anti-rheumatic drugs (bDMARDs) or small molecule inhibitors with moderately to severely active RA who have had an inadequate response or intolerance to methotrexate and naive to any bDMARDs or small molecule inhibitors.

You may qualify if:

• Patients are included in this study if they are:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanyang University: lead
• Ministry of Health, Republic of Korea: collaborator

Study Sites (1)

Hanyang University

Seoul, 04763, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum (restricted to a patient who provides written consent to biosampling)

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases

Interventions

Etanercept; tocilizumab; Abatacept; Adalimumab; tofacitinib; baricitinib

Condition Hierarchy (Ancestors)

Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Immunoconjugates; Antibodies; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal

Study Officials

• Yoon-Kyoung Sung, MD, PhD, MPH

  Hanyang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoon-Kyoung Sung, MD, PhD, MPH

CONTACT

82-2-2290-9250; sungyk@hanyang.ac.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 48 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 7, 2020
• First Posted: June 26, 2020
• Study Start: April 27, 2020
• Primary Completion: August 19, 2023
• Study Completion: August 19, 2024
• Last Updated: June 26, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)