Safety and Retention Rate of the JAK and TNF Inhibitors i... | NCT05182203

Studies
Safety and Retention Rate of the JAK and TNF Inhibitors in Rheumatoid Arthritis: a Real-life Experience

NCT05182203

Sponsor

Tuen Mun Hospital

Status

Completed

Last Update Posted

Feb 22, 2023Actual

Enrollment

1,732Actual

Phase

Not provided

Conditions

Rheumatoid Arthritis
Drug Use

Interventions

biologic/targeted therapy

Countries

China

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

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2022Actual

Primary Completion Date

Sep 1, 2022Actual

Completion Date

Oct 1, 2022Actual

First Submitted Date

Dec 18, 2021

First Submission Date that Met QC Criteria

Jan 5, 2022

First Posted Date

Jan 10, 2022Actual

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

Feb 20, 2023

Last Update Posted Date

Feb 22, 2023Actual

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 extract data from the Hong Kong Biologics Registry for retention rate of the JAK inhibitors in rheumatoid arthritis and review other adverse events by looking at the medical record retrospectively. These real life data are important as they cannot be provided by randomized controlled trials which are limited by the duration of observation and fixed protocols in research settings. Moreover, data will represent our local experience of the JAK inhibitors in Chinese patients with RA. The retention rate and adverse effects of the JAK inhibitors are compared with conventional TNF inhibitors.

Detailed Description

This study aims to extract data from the Hong Kong Biologics Registry for retention rate of the JAK inhibitors in rheumatoid arthritis and review other adverse events by looking at the medical record retrospectively. Efficacy data and adverse events, in particular major adverse cardiovascular events (MACEs) and malignancy will be looked at and compared with the TNF inhibitors. Retention / withdrawal rates of the drugs will be studied by statistical analyses.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,732Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
JAK inhibitors		RA patients treated with JAK inhibitors	Drug: biologic/targeted therapy
TNF inhibitors		RA patients treated with TNF inhibitors	Drug: biologic/targeted therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
biologic/targeted therapy	Drug	TNF inhibitors or the JAK inhibitors	JAK inhibitors TNF inhibitors

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Withdrawal rate due to major / serious adverse events	adverse events eg. MACEs, malignancy, infections	from start of biologic/targeted DMARD use to these event(s) up to 10 years

Secondary Outcomes

Measure	Description	Time Frame
Withdrawal rate due to inefficacy	Efficacy of the agents in terms of retention rate	from start of biologic/targeted DMARD use to last clinic visit up to 10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All RA patients in our biologics registry treated with the JAK inhibitors (N=411)
All RA patients in our biologics registry treated with the TNF inhibitors (N=1392)

Exclusion Criteria:

- RA patients in our biologics registry treated with other biologic/targeted DMARDs

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Diagnosis of RA Ever received treatment with any biologic/targeted DMARDs data entered into our Biologics registry age >=18 years

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chi Chiu Mok, MD, FRCP	Tuen Mun Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Medicine, Tuen Mun Hospital		Hong Kong		000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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