Safety and Retention Rate of the JAK Inhibitors in Rheumatoid Arthritis: a Real-life Experience
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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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 Design
Arms and Interventions
Arm | 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
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Department of Medicine, Tuen Mun Hospital | Hong Kong | China | 000 |
Sponsors and Collaborators
- Tuen Mun Hospital
Investigators
- Principal Investigator: Chi Chiu Mok, MD, FRCP, Tuen Mun Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HKSRJAK study