Study of Tapering and Discontinuing Biological DMARDs in Rheumatoid Arthritis Patients

Rheumatoid Arthritis Clinical Trial

Official title:

Study of Tapering and Discontinuing Biological DMARDs in Rheumatoid Arthritis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04472390
• Other study ID #: 201911037RIND
• Status: Recruiting
• Start date: December 3, 2019
• Est. completion date: December 2021

Study information

• Verified date: December 2019
• Source: National Taiwan University Hospital
• Contact: Yen-Hui Chen
• Phone: 33668790
• Email: tcyhchen[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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-a 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-a inhibitors (2011/1/1-2019/4/30)

Exclusion criteria:

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei	Zhongzheng District

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to disease relapse	me to relapse after tapering or discontinuing TNF-a inhibitors	hrough study completion, an average of 10 year