Skip to main content
OpenTrials
Completed

NCT Number: NCT05182203

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Drug Use Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Medicine, Tuen Mun Hospital

Hong Kong, 000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biologic/targeted therapy

Drug

TNF inhibitors or the JAK inhibitors

Primary outcomes

  1. Withdrawal rate due to major / serious adverse events

    Time frame: from start of biologic/targeted DMARD use to these event(s) up to 10 years

    adverse events eg. MACEs, malignancy, infections

Secondary outcomes

  1. Withdrawal rate due to inefficacy

    Time frame: from start of biologic/targeted DMARD use to last clinic visit up to 10 years

    Efficacy of the agents in terms of retention rate

Sponsors and collaborators

Lead sponsor

Tuen Mun Hospital

Other Gov

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 10, 2022
Registry last updated
Feb 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.