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)

Eisai

Status: Completed

Conditions: Arthritis, Rheumatoid

Study type: Observational

Funder types: Industry

Identifiers

NCT03264703

D2E7-M082-601

Details and patient eligibility

About

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).

Enrollment: 212 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

212 participants in 1 patient group

Participants with RA with cDMARD, but no anti-TNF experience

Description:

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.