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

February 20, 2023 updated by: Chi Chiu Mok, Tuen Mun Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1732

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Hong Kong, China, 000
        • Department of Medicine, Tuen Mun Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
JAK inhibitors
RA patients treated with JAK inhibitors
Drug: biologic/targeted therapy
TNF inhibitors or the JAK inhibitors
TNF inhibitors
RA patients treated with TNF inhibitors
Drug: biologic/targeted therapy
TNF inhibitors or the JAK inhibitors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from start of biologic/targeted DMARD use to these event(s) up to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from start of biologic/targeted DMARD use to last clinic visit up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tuen Mun Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

October 1, 2022

Study Registration Dates

First Submitted

December 18, 2021

First Submitted That Met QC Criteria

January 5, 2022

First Posted (Actual)

January 10, 2022

Study Record Updates

Last Update Posted (Estimate)

February 22, 2023

Last Update Submitted That Met QC Criteria

February 20, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HKSRJAK study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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