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 | Crick

Overview

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 Type

OBSERVATIONAL

Enrollment

212

Conditions

Arthritis, Rheumatoid

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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)

Eisai Trial Site # 1

Ilsan, Gyeonggi-do, South Korea

Eisai Trial Site # 1

Busan, South Korea

Eisai Trial Site # 2

Busan, South Korea

Outcomes

Primary Outcomes

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.

Time frame: Baseline; Month 6

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.