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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05182203
• Other study ID #: HKSRJAK study
• Status: Completed
• Start date: March 1, 2022
• Est. completion date: October 1, 2022

Study information

• Verified date: February 2023
• Source: Tuen Mun Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1732
• Est. completion date: October 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Drug Use
• Rheumatoid Arthritis

Intervention

Drug:
• biologic/targeted therapy
TNF inhibitors or the JAK inhibitors

Locations

Country	Name	City	State
China	Department of Medicine, Tuen Mun Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Tuen Mun Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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