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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05182203

Enrollment

1732

Registered

2022-01-10

Start date

2022-03-01

Completion date

2022-10-01

Last updated

2023-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Use, Rheumatoid Arthritis

Keywords

rheumatoid arthitis, biological agents, targeted agents

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.

Interventions

DRUGbiologic/targeted therapy

TNF inhibitors or the JAK inhibitors

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026