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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT04449224
Date of registration: 07/06/2020
Prospective Registration: Yes
Primary sponsor: Hanyang University
Public title: Comparative Effectiveness of Targeted Therapy in RA Patients
Scientific title: Comparative Effectiveness of Biologic Disease-modifying Antirheumatic Drugs and Small Molecular Inhibitors in Patients With Moderate to Severe RA: Prospective Observational Study
Date of first enrolment: April 27, 2020
Target sample size: 506
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT04449224
Study type:  Observational [Patient Registry]
Study design:   
Phase: 
Countries of recruitment
Korea, Republic of
Contacts
Name:     Yoon-Kyoung Sung, MD, PhD, MPH
Address: 
Telephone: 82-2-2290-9250
Email: sungyk@hanyang.ac.kr
Affiliation: 
Name:     Yoon-Kyoung Sung, MD, PhD, MPH
Address: 
Telephone: 82-2-2290-9250
Email: sungyk@hanyang.ac.kr
Affiliation: 
Name:     Yoon-Kyoung Sung, MD, PhD, MPH
Address: 
Telephone:
Email:
Affiliation:  Hanyang University
Key inclusion & exclusion 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



Age minimum: 19 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Adalimuab, Etanercept, Tocilizumab, or Abatacept
Drug: Tofacitinib or Baricitinib
Primary Outcome(s)
Percentage of participants achieving low disease activity according to Disease Activity Score 28 joints-Erythrocyte sedimentation (DAS28-ESR) [Time Frame: At weeks 24]
Secondary Outcome(s)
Biomarkers predictive of treatment response of RA (if possible) [Time Frame: At weeks 24]
Changes in EuroQol visual analogue scale (EQ VAS) [Time Frame: At weeks 12, 24, and 48]
Changes in EuroQol-5 dimension (EQ-5D) [Time Frame: At weeks 12, 24, and 48]
Changes in Health Assessment Questionnaire (HAQ) [Time Frame: At weeks 12, 24, and 48]
Compliance with targeted therapy defined by Patient-reported adherence and Modified Morisky scale (if possible) [Time Frame: At weeks 48]
Incidence of adverse events (AEs) or serious adverse events (SAEs) of targeted therapy (if possible) [Time Frame: At weeks 48]
Percentage of participants achieving low disease activity according to Disease Activity Score 28 joints-Erythrocyte sedimentation rate (DAS28-ESR) [Time Frame: At weeks 12 and 48]
Percentage of participants achieving remission according to Disease Activity Score 28 joints-Erythrocyte sedimentation rate (DAS28-ESR) [Time Frame: At weeks 12, 24, and 48]
Percentage of participants having changes in ultrasonographic findings of RA (if possible) [Time Frame: At weeks 48]
Percentage of participants having radiologic progression in RA (if possible) [Time Frame: At weeks 48]
Percentage of participants with European League Against Rheumatism (EULAR) Response according to Disease Activity Score 28 joints-Erythrocyte sedimentation rate (DAS28-ESR) [Time Frame: At weeks 12, 24, and 48]
Secondary ID(s)
HUHRD-SPE-20-01
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ministry of Health, Republic of Korea
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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