Rheumatoid ArthritisNCT04449224
Comparative Effectiveness of Targeted Therapy in RA Patients
An observational study of Rheumatoid Arthritis, run by Hanyang University at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Adalimuab, Etanercept, Tocilizumab, or Abatacept and Tofacitinib or Baricitinib
- How many people
- 506 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Apr 2020to 19 Aug 2024
- How long will I take part?
- 48 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hanyang University
Seoul, 04763
Yoon-Kyoung Sung, MD, PhD, MPH, 82-2-2290-9250, sungyk@hanyang.ac.kr
About this study
Official title: Comparative Effectiveness of Biologic Disease-modifying Antirheumatic Drugs and Small Molecular Inhibitors in Patients With Moderate to Severe RA: Prospective Observational Study
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.
Read the 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
- Being tested
- Adalimuab, Etanercept, Tocilizumab, or Abatacept, Tofacitinib or Baricitinib
- Keywords
- Arthritis, Arthritis, Rheumatoid, Joint Diseases, Musculoskeletal Diseases
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Joint Diseases, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adalimuab, Etanercept, Tocilizumab, or AbataceptDrug
Also called Humira, Enbrel, Etoloche, Eucept, Actemra, or Orencia
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 BaricitinibDrug
Also called Xeljanz or Olumiant
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Tofacitinib or Baricitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At weeks 24
Secondary outcomes (11)
Changes in Health Assessment Questionnaire (HAQ)
The HAQ-DI is a patient-reported assessment of physical function that includes 20 items in eight categories representing a comprehensive set of functional activities, including dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Patients are asked about their ability to complete these tasks in the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst), with a higher score representing a high-dependency disability.
Measured: At weeks 12, 24, and 48
Changes in EuroQol-5 dimension (EQ-5D)
The EQ-5D is a generic instrument for measuring health-related quality of life. The EQ-5D-5L essentially consists of two parts: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). Patients are asked about their ability to complete specific tasks today using the following dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). EQ-5D-5L health states can be summarised using the 5-digit code, after that, it is represented by a single summary number (index scores). Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility.
Measured: At weeks 12, 24, and 48
Changes in EuroQol visual analogue scale (EQ VAS)
The EQ-5D is a generic instrument for measuring health-related quality of life. The EQ-5D-5L essentially consists of two parts: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The second part of the questionnaire consists of a visual analogue scale (VAS) on which the patient rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).
Measured: 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)
Disease Activity Score 28 joints-Erythrocyte sedimentation (DAS28-ESR) below 3.2 indicates low disease activity of RA.
Measured: At weeks 12 and 48
Percentage of participants achieving remission according to Disease Activity Score 28 joints-Erythrocyte sedimentation rate (DAS28-ESR)
Disease Activity Score 28 joints-Erythrocyte sedimentation (DAS28-ESR) below 2.6 indicates remission of RA.
Measured: At weeks 12, 24, and 48
Percentage of participants with European League Against Rheumatism (EULAR) Response according to Disease Activity Score 28 joints-Erythrocyte sedimentation rate (DAS28-ESR)
The European League Against Rheumatism (EULAR) response criteria classify patients as good, moderate, or nonresponders, using the individual amount of change in DAS28 and the level of DAS reached (low, moderate, or high); good responders were patients with an improvement of >1.2 and a present score of ≤3.2; moderate responders were patients with an improvement of >0.6 to ≤1.2 and a present score of ≤5.1, or an improvement of >1.2 and a present score of >3.2; non-responders were any patients with an improvement of ≤0.6, or patients with an improvement of >0.6 to 1.2 and a present score of >5.1
Measured: At weeks 12, 24, and 48
Percentage of participants having radiologic progression in RA (if possible)
Percentage of participants having radiologic progression in rheumatoid arthritis (if possible)
Measured: At weeks 48
Percentage of participants having changes in ultrasonographic findings of RA (if possible)
Percentage of participants having changes in ultrasonographic findings of rheumatoid arthritis (if possible)
Measured: At weeks 48
Biomarkers predictive of treatment response of RA (if possible)
We would like to discover serum biomarkers predicting 24-week treatment response in each targeted therapy for RA patients. Serum samples will be collected before target therapies (at 0 week) and grouped according to the treatment response after 24 weeks. The putative biomarkers predicting treatment response will be screened using proteomics method and validated via ELISA.
Measured: At weeks 24
Incidence of adverse events (AEs) or serious adverse events (SAEs) of targeted therapy (if possible)
Incidence of adverse events (AEs) or serious adverse events (SAEs) of targeted therapy (if possible)
Measured: At weeks 48
Compliance with targeted therapy defined by Patient-reported adherence and Modified Morisky scale (if possible)
This 6-item questionnaire measures two domains of adherence; knowledge and motivation. Patients are categorized as having 'high' or 'low' knowledge and motivation based on their yes or no response to each of the six questions of the Modified Morisky Scale. Each 'no' response to each question results in +1 (except question 5, in which a 'yes' response would result in +1) and 'yes' responses to each question result in +0 (except question 5, where a 'no' response would result in +0). Scores for the 6-item of Modified Morisky Scale can range from 0 to 6, with higher scores indicating better adherence.
Measured: At weeks 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2020
- Study start27 Apr 2020
- Primary completion19 Aug 2023 (estimated)
- Study completion19 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 506 participants (estimated)
- Target duration
- 48 Weeks
Sponsor and investigators
- Lead sponsor
- Hanyang University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Republic of Korea
- Responsible party
- Principal investigator, Yoon-Kyoung Sung, Hanyang University
- Investigators
- Yoon-Kyoung Sung, MD, PhD, MPH, Principal investigator, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449224
- Sponsor's protocol ID
- HUHRD-SPE-20-01
- Status last verified
- Jun 2020
- First submitted
- 7 Jun 2020
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cho SK, Choi SR, Nam E, Sung YK. Validation of Boolean 2.0 criteria for remission and quality of life prediction in Korean patients with rheumatoid arthritis receiving targeted therapy. Rheumatology (Oxford). 2026 Jan 8;65(1):keaf516. doi: 10.1093/rheumatology/keaf516.
PubMed 41025512
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Biologic Disease-modifying Antirheumatic Drugs and Small Molecular Inhibitors in Patients With Moderate to Severe RA: Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04449224
- Acronym / sponsor ID
- HUHRD-SPE-20-01
- Conditions
- Rheumatoid Arthritis
- Keywords
- Arthritis, Arthritis, Rheumatoid, Joint Diseases, Musculoskeletal Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 506 participants (estimated)
- Lead sponsor
- Hanyang UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health, Republic of Korea
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 19 Aug 2023 (estimated)
- Study completion
- 19 Aug 2024 (estimated)
- First posted
- 26 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 48 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RA patients who start bDMARD | – | Drug: Adalimuab, Etanercept, Tocilizumab, or AbataceptThe 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. |
| RA patients who start small molecule inhibitor | – | Drug: Tofacitinib or BaricitinibThe 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adalimuab, Etanercept, Tocilizumab, or AbataceptAlso: Humira, Enbrel, Etoloche, Eucept, Actemra, or OrenciaA 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 | RA patients who start bDMARD |
| Tofacitinib or BaricitinibAlso: Xeljanz or OlumiantA 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 | RA patients who start small molecule inhibitor |
Primary outcome
Percentage of participants achieving low disease activity according to Disease Activity Score 28 joints-Erythrocyte sedimentation (DAS28-ESR)
Time frame: At weeks 24
Disease Activity Score 28 joints-Erythrocyte sedimentation (DAS28-ESR) below 3.2 indicates low disease activity of RA.
11 secondary outcomes
Changes in Health Assessment Questionnaire (HAQ)
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 EuroQol visual analogue scale (EQ VAS)
Time frame: 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)
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 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
Percentage of participants having radiologic progression in RA (if possible)
Time frame: At weeks 48
Percentage of participants having changes in ultrasonographic findings of RA (if possible)
Time frame: At weeks 48
Biomarkers predictive of treatment response of RA (if possible)
Time frame: At weeks 24
Incidence of adverse events (AEs) or serious adverse events (SAEs) of targeted therapy (if possible)
Time frame: At weeks 48
Compliance with targeted therapy defined by Patient-reported adherence and Modified Morisky scale (if possible)
Time frame: At weeks 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
- Derived from this study: PubMed 41025512Cho SK, Choi SR, Nam E, Sung YK. Validation of Boolean 2.0 criteria for remission and quality of life prediction in Korean patients with rheumatoid arthritis receiving targeted therapy. Rheumatology (Oxford). 2026 Jan 8;65(1):keaf516. doi: 10.1093/rheumatology/keaf516.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoon-Kyoung Sung, MD, PhD, MPH principal investigator
Hanyang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Hanyang University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yoon-Kyoung Sung, MD, PhD, MPH (82-2-2290-9250, sungyk@hanyang.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04449224, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2020.