Clinical trial NCT03264703: 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
Official title: 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]
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid
Keywords: Joint pain
Joint stiffness
Joint redness
Loss of joint function
Swollen joints
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2017-08-29
Enrollment: 212
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in the disease activity score 28-erythrocyte sedimentation rate DAS28-ESR at Month 6
timeFrame: Baseline; Month 6
Secondary outcomes:
measure: Change from Baseline in the DAS28-ESR at Month 3
timeFrame: Baseline; Month 3
measure: Change from Baseline in the DAS28-ESR at Month 12
timeFrame: Baseline; Month 12
measure: Clinical remission rate measured by DAS28-ESR
timeFrame: Up to 12 months
measure: Success rates of dose-reduction and discontinuation of steroid(s)
timeFrame: Up to 12 months
measure: Scores on the Korean Health Assessment Questionnaire (KHAQ-20), as a measure of quality of life
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Ilsan
country: Korea, Republic of
facility: Eisai Trial Site # 1
state: Gyeonggi-do
city: Busan
country: Korea, Republic of
facility: Eisai Trial Site # 1
city: Busan
country: Korea, Republic of
facility: Eisai Trial Site # 2
city: Busan
country: Korea, Republic of
facility: Eisai Trial Site # 3
city: Busan
country: Korea, Republic of
facility: Eisai Trial Site # 4
city: Daegu
country: Korea, Republic of
facility: Eisai Trial Site # 1
city: Daegu
country: Korea, Republic of
facility: Eisai Trial Site # 2
city: Seoul
country: Korea, Republic of
facility: Eisai Trial Site # 1
city: Seoul
country: Korea, Republic of
facility: Eisai Trial Site # 2
city: Seoul
country: Korea, Republic of
facility: Eisai Trial Site # 3
city: Seoul
country: Korea, Republic of
facility: Eisai Trial Site # 4
city: Seoul
country: Korea, Republic of
facility: Eisai Trial Site # 5
city: Seoul
country: Korea, Republic of
facility: Eisai Trial Site # 6
city: Seoul
country: Korea, Republic of
facility: Eisai Trial Site # 7
city: Seoul
country: Korea, Republic of
facility: Eisai Trial Site # 8
Study officials:
References: