Study of Tapering and Discontinuing Biological DMARDs in... | NCT04472390

Studies
Study of Tapering and Discontinuing Biological DMARDs in Rheumatoid Arthritis Patients

NCT04472390

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Jul 15, 2020Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Rheumatoid Arthritis

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 3, 2019Actual

Primary Completion Date

Dec 2021Estimated

Completion Date

Dec 2021Estimated

First Submitted Date

Jul 8, 2020

First Submission Date that Met QC Criteria

Jul 13, 2020

First Posted Date

Jul 15, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2020

Last Update Posted Date

Jul 15, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tapering		TNF-α inhibitors
Discontinuing		TNF-α inhibitors

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yen-Hui Chen	Contact	33668790		tcyhchen@ntu.edu.tw

Overall Officials

Name	Affiliation	Role
Yen-Hui Chen	NTU Clinical Pharmacy School	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei	Zhongzheng District	100	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided