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

NCT03264703 — Completed, 212 participants, Eisai Korea Inc.

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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]

RegistryNCT03264703, acronym HUMAN
StatusCompleted
Study typeObservational
Enrollment212 (Actual)
SponsorEisai Korea Inc. (Industry)
ConditionsArthritis, Rheumatoid
Datesstart 2017-09-11, primary completion 2019-07-17, completion 2019-07-17, first posted 2017-08-29, last updated 2020-12-16
Locations15 sites in South Korea

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All trials for Arthritis, Rheumatoid

-Summary

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).

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+Arms and interventions

ArmTypeInterventionsDescription
Participants with RA with cDMARD, but no anti-TNF experienceMale 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.

+Outcome measures

Primary outcomes

  • Change from Baseline in the disease activity score 28-erythrocyte sedimentation rate DAS28-ESR at Month 6 [Baseline; 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.

Secondary outcomes

  • Change from Baseline in the DAS28-ESR at Month 3 [Baseline; 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.
  • Change from Baseline in the DAS28-ESR at Month 12 [Baseline; 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.
  • Clinical remission rate measured by DAS28-ESR [Up to 12 months]: Clinical remission is defined as no tender or swollen joints and a normal erythrocyte sedimentation rate. DAS28 will be used to measure disease activity.
  • Success rates of dose-reduction and discontinuation of steroid(s) [Up to 12 months]: Dose reduction is defined as a reduction by more than 50% compared to baseline.
  • Scores on the Korean Health Assessment Questionnaire (KHAQ-20), as a measure of quality of life [Up to 12 months]: 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.

+Eligibility

Sex: All

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

+Locations (15)

FacilityCityCountryStatus
Eisai Trial Site # 1Ilsan, Gyeonggi-doSouth Korea
Eisai Trial Site # 1BusanSouth Korea
Eisai Trial Site # 2BusanSouth Korea
Eisai Trial Site # 3BusanSouth Korea
Eisai Trial Site # 4BusanSouth Korea
Eisai Trial Site # 1DaeguSouth Korea
Eisai Trial Site # 2DaeguSouth Korea
Eisai Trial Site # 1SeoulSouth Korea
Eisai Trial Site # 2SeoulSouth Korea
Eisai Trial Site # 3SeoulSouth Korea
Eisai Trial Site # 4SeoulSouth Korea
Eisai Trial Site # 5SeoulSouth Korea
Eisai Trial Site # 6SeoulSouth Korea
Eisai Trial Site # 7SeoulSouth Korea
Eisai Trial Site # 8SeoulSouth Korea