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

NCT ID: NCT05182203

Last Updated: 2023-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1732 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-01

Study Completion Date

2022-10-01

Brief Summary

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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

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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.

Conditions

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Rheumatoid Arthritis Drug Use

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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JAK inhibitors

RA patients treated with JAK inhibitors

biologic/targeted therapy

Intervention Type DRUG

TNF inhibitors or the JAK inhibitors

TNF inhibitors

RA patients treated with TNF inhibitors

biologic/targeted therapy

Intervention Type DRUG

TNF inhibitors or the JAK inhibitors

Interventions

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biologic/targeted therapy

TNF inhibitors or the JAK inhibitors

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tuen Mun Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Chi Chiu Mok

Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chi Chiu Mok, MD, FRCP

Role: PRINCIPAL_INVESTIGATOR

Tuen Mun Hospital

Locations

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Department of Medicine, Tuen Mun Hospital

Hong Kong, , China

Site Status

Countries

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China

Other Identifiers

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HKSRJAK study

Identifier Type: -

Identifier Source: org_study_id

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