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

Arthritis, Rheumatoid Clinical Trial

— HUMAN  

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]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03264703
• Other study ID #: D2E7-M082-601
• Status: Completed
• Start date: September 11, 2017
• Est. completion date: July 17, 2019

Study information

• Verified date: March 2020
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: July 17, 2019
• Est. primary completion date: July 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Locations

Country	Name	City	State
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	Busan
Korea, Republic of	Eisai Trial Site # 1	Daegu
Korea, Republic of	Eisai Trial Site # 2	Daegu
Korea, Republic of	Eisai Trial Site # 1	Ilsan	Gyeonggi-do
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	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Korea Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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