Study in Patients With Moderated to Severe Rheumatoid Arthritis Who Have Failed to Combination Therapy of Conventional Disease-modifying Antirheumatic Drugs (cDMARDs) to cDMARD Plus ANti-TNF Versus cDMARDs in Real World (HUMAN)

An Observational Study in Patients With Moderated to Severe Rheumatoid Arthritis Who Have Failed to Combination Therapy of Conventional Disease-modifying Antirheumatic Drugs (cDMARDs) to cDMARD Plus Anti-TNF Versus cDMARDs in Real World ["HUMAN" Study]

This study will be conducted to observe the disease activity change of Conventional Disease Modifying Anti-Rheumatic Drugs (cDMARD) plus anti-tumour necrosis factor (anti-TNF) from baseline to 6 months compared with cDMARDs, as measured by the disease activity score with the erythrocyte sedimentation rate (DAS28-ESR).

Study Overview

• Status: Completed
• Conditions: Arthritis, Rheumatoid

• Study Type: Observational
• Enrollment (Actual): 212

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Eisai Trial Site # 1
  • Busan, Korea, Republic of
    • Eisai Trial Site # 2
  • Busan, Korea, Republic of
    • Eisai Trial Site # 3
  • Busan, Korea, Republic of
    • Eisai Trial Site # 4
  • Daegu, Korea, Republic of
    • Eisai Trial Site # 1
  • Daegu, Korea, Republic of
    • Eisai Trial Site # 2
  • Seoul, Korea, Republic of
    • Eisai Trial Site # 1
  • Seoul, Korea, Republic of
    • Eisai Trial Site # 2
  • Seoul, Korea, Republic of
    • Eisai Trial Site # 3
  • Seoul, Korea, Republic of
    • Eisai Trial Site # 4
  • Seoul, Korea, Republic of
    • Eisai Trial Site # 5
  • Seoul, Korea, Republic of
    • Eisai Trial Site # 6
  • Seoul, Korea, Republic of
    • Eisai Trial Site # 7
  • Seoul, Korea, Republic of
    • Eisai Trial Site # 8
  • Gyeonggi-do
    • Ilsan, Gyeonggi-do, Korea, Republic of
      • Eisai Trial Site # 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Male and female participants diagnosed with rheumatoid arthritis (RA), who have no experience with anti-tumor necrosis factor (anti-TNF) and who have experienced two or more Conventional Disease Modifying Anti-Rheumatic Drugs (cDMARDs) of a stable dose for at least 3 months.

Description

Inclusion Criteria:

• Diagnosed with rheumatoid arthritis within 3 years
• Participants who have no experience with anti-tumor necrosis factor (anti-TNF)
• Participants who have experienced two or more Conventional Disease Modifying Anti-Rheumatic Drugs (cDMARDs) of a stable dose for at least 3 months prior to informed consent

• Participants who change the treatment regimen to one of the following according to the opinion of the investigator:

  1. One cDMARD plus anti-TNF
  2. Two or more cDMARDs: Modifications or additions of cDMARDs that have been treated prior to informed consent

Exclusion Criteria:

• Participants who may be pregnant or lactating women
• Participants who have contraindication to anti-TNF
• Participants who had participated in this study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Participants with RA with cDMARD, but no anti-TNF experience; Male and female participants diagnosed with rheumatoid arthritis (RA), who have no experience with anti-tumor necrosis factor (anti-TNF) and who have experienced two or more Conventional Disease Modifying Anti-Rheumatic Drugs (cDMARDs) of a stable dose for at least 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in the disease activity score 28-erythrocyte sedimentation rate DAS28-ESR at Month 6	DAS28 is a quantitative tool used to measure and monitor disease activity and "the treatment" of rheumatoid arthritis. DAS28 uses a formula that includes the number of tender joints and swollen joints for a maximum of 28 joints. DAS28 is used to assess whether an individual participant has a significant improvement of the disease activity, compared to baseline. A DAS28 score greater than 5.1 implies active disease, a score less than 3.2 implies low disease activity, and a score less than 2.6 implies remission.	Baseline; Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in the DAS28-ESR at Month 3	DAS28 is a quantitative tool used to measure and monitor disease activity and "the treatment" of rheumatoid arthritis. DAS28 uses a formula that includes the number of tender joints and swollen joints for a maximum of 28 joints. DAS28 is used to assess whether an individual participant has a significant improvement of the disease activity, compared to baseline. A DAS28 score greater than 5.1 implies active disease, a score less than 3.2 implies low disease activity, and a score less than 2.6 implies remission.	Baseline; Month 3
Change from Baseline in the DAS28-ESR at Month 12	DAS28 is a quantitative tool used to measure and monitor disease activity and "the treatment" of rheumatoid arthritis. DAS28 uses a formula that includes the number of tender joints and swollen joints for a maximum of 28 joints. DAS28 is used to assess whether an individual participant has a significant improvement of the disease activity, compared to baseline. A DAS28 score greater than 5.1 implies active disease, a score less than 3.2 implies low disease activity, and a score less than 2.6 implies remission.	Baseline; Month 12
Clinical remission rate measured by DAS28-ESR	Clinical remission is defined as no tender or swollen joints and a normal erythrocyte sedimentation rate. DAS28 will be used to measure disease activity.	Up to 12 months
Success rates of dose-reduction and discontinuation of steroid(s)	Dose reduction is defined as a reduction by more than 50% compared to baseline.	Up to 12 months
Scores on the Korean Health Assessment Questionnaire (KHAQ-20), as a measure of quality of life	The KHAQ-20 is a participant-assessed measure of health assessment comprised of 8 indices. Scores for each index range from 0 (no difficulty to do) to 3 (unable to do). The total score is a sum of the 8 index score and ranges from 0 to 24. Higher scores indicate more severe disease.	Up to 12 months

Collaborators and Investigators

• Sponsor: Eisai Korea Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2017
• Primary Completion (Actual): July 17, 2019
• Study Completion (Actual): July 17, 2019

Study Registration Dates

• First Submitted: August 25, 2017
• First Submitted That Met QC Criteria: August 25, 2017
• First Posted (Actual): August 29, 2017

Study Record Updates

• Last Update Posted (Actual): December 16, 2020
• Last Update Submitted That Met QC Criteria: December 14, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Joint pain; Joint stiffness; Joint redness; Loss of joint function; Swollen joints
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: D2E7-M082-601

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No