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

Sponsor
Tuen Mun Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05182203
Collaborator
(none)
1,800
Enrollment
1
Location
11
Anticipated Duration (Months)
164
Patients Per Site Per Month

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
  • Drug: biologic/targeted therapy

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

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
1800 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Safety and Retention Rate of the JAK Inhibitors in Rheumatoid Arthritis: a Real-life Experience
Anticipated Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

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

  1. 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

  1. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Responsible Party:
Chi Chiu Mok, Consultant, Tuen Mun Hospital
ClinicalTrials.gov Identifier:
NCT05182203
Other Study ID Numbers:
  • HKSRJAK study
First Posted:
Jan 10, 2022
Last Update Posted:
Jan 10, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Chi Chiu Mok, Consultant, Tuen Mun Hospital
rheumatoid arthitis
biological agents
targeted agents
Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid

Study Results

No Results Posted as of Jan 10, 2022