Study of Tapering and Discontinuing Biological DMARDs in Rheumatoid Arthritis Patients

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.

Study Overview

• Status: Unknown
• Conditions: Rheumatoid Arthritis

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• Taiwan
  • Zhongzheng District
    • Taipei, Zhongzheng District, Taiwan, 100
      • Recruiting
      • National Taiwan University Hospital
      • Contact: Yen-Hui Chen; Phone Number: 33668790; Email: tcyhchen@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

There are 90 patients included in this cohort study, 89 patients underwent tapering of TNF-α inhibitors.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Tapering; TNF-α inhibitors
Discontinuing; TNF-α inhibitors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to disease relapse	me to relapse after tapering or discontinuing TNF-α inhibitors	hrough study completion, an average of 10 year

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Yen-Hui Chen, NTU Clinical Pharmacy School

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2019
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: July 8, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (Actual): July 15, 2020

Study Record Updates

• Last Update Posted (Actual): July 15, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: biological DMARDs
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: 201911037RIND

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No