NCT04472390

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 3, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 15, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

July 15, 2020

Status Verified

December 1, 2019

Enrollment Period

2 years

First QC Date

July 8, 2020

Last Update Submit

July 13, 2020

Conditions

Rheumatoid Arthritis

Keywords

biological DMARDs

Outcome Measures

Primary Outcomes (1)

  • time to disease relapse

    me to relapse after tapering or discontinuing TNF-α inhibitors

    hrough study completion, an average of 10 year

Study Arms (2)

Tapering

TNF-α inhibitors

Discontinuing

TNF-α inhibitors

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Zhongzheng District, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Yen-Hui Chen

    NTU Clinical Pharmacy School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yen-Hui Chen

CONTACT

33668790tcyhchen@ntu.edu.tw

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2020

First Posted

July 15, 2020

Study Start

December 3, 2019

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

July 15, 2020

Record last verified: 2019-12

Locations

TW(1)