Study of Tapering and Discontinuing Biological DMARDs in Rheumatoid Arthritis Patients

National Taiwan University

Status: Unknown

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: Other

Identifiers

NCT04472390

201911037RIND

Details and patient eligibility

About

This study aims to analyses time to disease relapse of RA patients if TNF-α inhibitors are being tapered, the predictive factors that are associated with successful taper of TNF-α inhibitors. Also, investigate the effects associated with dose tapering of TNF-α inhibitors.

Enrollment: 400 estimated patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Diagnosed of RA based on the 1987 American College of Rheumatology (ACR) criteria and/or 2010 ACR/EULAR classification criteria of RA depending on the time of diagnosis Age ≥ 20 years old TNF-α inhibitors was prescribed for RA patients refractory to csDMARDs (defined as csDMARD therapy for over 6 months) during 2003/5/2 - 2017/4/30 Dose reduction or discontinuation use of TNF-α inhibitors (2011/1/1-2019/4/30)

Exclusion criteria

TNF-α inhibitors were discontinued or tapered due to adverse events such as infection, liver transaminase elevation, malignancy and neutropenia.

Trial design

400 participants in 2 patient groups

Tapering

Description:

TNF-α inhibitors

Discontinuing

Description:

TNF-α inhibitors