Clinical trial NCT04449224: Comparative Effectiveness of Targeted Therapy in RA Patients
Official title: Comparative Effectiveness of Biologic Disease-modifying Antirheumatic Drugs and Small Molecular Inhibitors in Patients With Moderate to Severe RA: Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Keywords: Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Lead sponsor: Hanyang University
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Republic of Korea
First posted: 2020-06-26
Enrollment: 506
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Percentage of participants achieving low disease activity according to Disease Activity Score 28 joints-Erythrocyte sedimentation (DAS28-ESR)
timeFrame: At weeks 24
Secondary outcomes:
measure: Changes in Health Assessment Questionnaire (HAQ)
timeFrame: At weeks 12, 24, and 48
measure: Changes in EuroQol-5 dimension (EQ-5D)
timeFrame: At weeks 12, 24, and 48
measure: Changes in EuroQol visual analogue scale (EQ VAS)
timeFrame: At weeks 12, 24, and 48
measure: Percentage of participants achieving low disease activity according to Disease Activity Score 28 joints-Erythrocyte sedimentation rate (DAS28-ESR)
timeFrame: At weeks 12 and 48
measure: Percentage of participants achieving remission according to Disease Activity Score 28 joints-Erythrocyte sedimentation rate (DAS28-ESR)
timeFrame: At weeks 12, 24, and 48
measure: Percentage of participants with European League Against Rheumatism (EULAR) Response according to Disease Activity Score 28 joints-Erythrocyte sedimentation rate (DAS28-ESR)
timeFrame: At weeks 12, 24, and 48
measure: Percentage of participants having radiologic progression in RA (if possible)
timeFrame: At weeks 48
measure: Percentage of participants having changes in ultrasonographic findings of RA (if possible)
timeFrame: At weeks 48
measure: Biomarkers predictive of treatment response of RA (if possible)
timeFrame: At weeks 24
measure: Incidence of adverse events (AEs) or serious adverse events (SAEs) of targeted therapy (if possible)
timeFrame: At weeks 48
measure: Compliance with targeted therapy defined by Patient-reported adherence and Modified Morisky scale (if possible)
timeFrame: At weeks 48
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University
Study officials:
affiliation: Hanyang University
name: Yoon-Kyoung Sung, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: