Rheumatoid ArthritisNCT05182203
Safety and Retention Rate of the JAK and TNF Inhibitors in Rheumatoid Arthritis: a Real-life Experience
An observational study of Rheumatoid Arthritis and Drug Use, run by Tuen Mun Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Drug Use
- What is being tested?
- biologic/targeted therapy
- How many people
- 1,732 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 1 Oct 2022
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diagnosis of RA Ever received treatment with any biologic/targeted DMARDs data entered into our Biologics registry age >=18 years
Who may be able to join
- 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)
Who cannot join
- RA patients in our biologics registry treated with other biologic/targeted DMARDs
Trial locations and contacts
1 site in 1 country.
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. 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.
Read the 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.
- Conditions
- Rheumatoid Arthritis, Drug Use
- Being tested
- biologic/targeted therapy
- Keywords
- rheumatoid arthitis, biological agents, targeted agents
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biologic/targeted therapyDrug
TNF inhibitors or the JAK inhibitors
| Study group | Role | What they receive |
|---|---|---|
| JAK inhibitors | RA patients treated with JAK inhibitors Receives: Drug: biologic/targeted therapy | |
| TNF inhibitors | RA patients treated with TNF inhibitors Receives: Drug: biologic/targeted therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Withdrawal rate due to major / serious adverse events
adverse events eg. MACEs, malignancy, infections
Measured: from start of biologic/targeted DMARD use to these event(s) up to 10 years
Secondary outcomes (1)
Withdrawal rate due to inefficacy
Efficacy of the agents in terms of retention rate
Measured: from start of biologic/targeted DMARD use to last clinic visit up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start1 Mar 2022
- Primary completion1 Sep 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,732 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Tuen Mun Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Chi Chiu Mok, Tuen Mun Hospital
- Investigators
- Chi Chiu Mok, MD, FRCP, Principal investigator, Tuen Mun Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182203
- Sponsor's protocol ID
- HKSRJAK study
- Status last verified
- Feb 2023
- First submitted
- 18 Dec 2021
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Retention Rate of the JAK and TNF Inhibitors in Rheumatoid Arthritis: a Real-life Experience
- ClinicalTrials.gov ID
- NCT05182203
- Acronym / sponsor ID
- HKSRJAK study
- Conditions
- Rheumatoid Arthritis, Drug Use
- Keywords
- rheumatoid arthitis, biological agents, targeted agents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,732 participants (actual)
- Lead sponsor
- Tuen Mun HospitalOther government
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JAK inhibitors | – | Drug: biologic/targeted therapyRA patients treated with JAK inhibitors |
| TNF inhibitors | – | Drug: biologic/targeted therapyRA patients treated with TNF inhibitors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosis of RA Ever received treatment with any biologic/targeted DMARDs data entered into our Biologics registry age >=18 years
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- RA patients in our biologics registry treated with other biologic/targeted DMARDs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biologic/targeted therapyTNF inhibitors or the JAK inhibitors | Drug | JAK inhibitors, TNF inhibitors |
Primary outcome
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
1 secondary outcome
Withdrawal rate due to inefficacy
Time frame: from start of biologic/targeted DMARD use to last clinic visit up to 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chi Chiu Mok, MD, FRCP principal investigator
Tuen Mun Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Drug Use, run by Tuen Mun Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.