Rheumatoid ArthritisNCT03011281
Effectiveness and Safety of Tofacitinib in Korean Patients With Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Hanyang University at 1 site in South Korea.
Trial summary
The objectives of this single center, prospective, non-interventional inception cohort is to understand patient characteristics, general treatment patterns, effectiveness, and safety of Tofacitinib for rheumatoid arthritis patients in the real-world setting. 1. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Tofacitinib
- How many people
- 378 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2016to Dec 2021
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Korean RA patients who start Tofacitinib with moderately to severely active RA who have had an inadequate response or intolerance to methotrexate or biologics
Who may be able to join
- Patients who provide a written informed consent form of participating in this study.
- Patients who are more than 19 years old. C. Patients with moderately to severely active rheumatoid arthritis as defined per EULAR guidelines, who have had an inadequate response or are intolerant to methotrexate.
Who cannot join
- Patients who do not provide a written informed consent form of participating in this study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hanyang University
Seoul, 04763
Yoon-kyoung Sung, MD, PhD, MPH, 82-2-2290-9250, sungyk@hanyang.ac.kr
About this study
The objectives of this single center, prospective, non-interventional inception cohort is to understand patient characteristics, general treatment patterns, effectiveness, and safety of Tofacitinib for rheumatoid arthritis patients in the real-world setting.
- To evaluate the baseline characteristics of Korean RA patients treated with Tofacitinib
- To evaluate the effectiveness and safety of Tofacitinib in clinical practice in Korean RA patients.
- To further evaluate safety, effectiveness and demographic characteristics of the patients treated with Tofacitinib matched with and compared to biologic DMARDs from the BIOPSY registry database.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Tofacitinib
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TofacitinibDrug
Also called Xeljanz
| Study group | Role | What they receive |
|---|---|---|
| RA patients who start Tofacitinib | Korean RA patients who start Tofacitinib with moderately to severely active RA who have had an inadequate response or intolerance to methotrexate or biologics. Receives: Drug: Tofacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
DAS28-ESR (erythrocyte sedimentation rate) remission (DAS28 < 2.6) rate (%)
Measured: 5 years
Secondary outcomes (11)
Assessment of efficacy with DAS28 (erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP))
Measured: 5 years
Assessment of safety based on adverse events that occur during 5 years of patient monitoring.
Measured: 5 years
Assessment of adherence with Patient-reported Adherence, and Medication Possession Ratio (MPR) at 24, 48, 72, 96, 120, 144, 168, 192, 216 and 240 weeks of clinical visit.
Measured: 5 years
Assessment of Quality of life by European Quality of Life-5 Dimensions (EQ-5D)
Measured: 5 years
Global Health assessment using Visual Analogue Scale (VAS)
Measured: 5 years
Assessment of fatigue by Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue)
Measured: 5 years
Assessment of sleep disturbance using Visual Analogue Scale (VAS)
Measured: 5 years
Assessment of efficacy with Simple Disease Activity Index (SDAI)
Measured: 5 years
Assessment of efficacy with Clinical Disease Activity Index (CDAI)
Measured: 5 years
Assessment of efficacy with European League Against Rheumatism (EULAR) response Criteria
Measured: 5 years
Assessment of Quality of life by Health Assessment Questionnaire Disability Index (HAQ-DI)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startSep 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 378 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Hanyang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoon-Kyoung Sung, Hanyang University
- Investigators
- Yoon-Kyoung Sung, MD, PhD, MPH, Principal investigator, Hanyang University Hospital for Rheumatic Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011281
- Sponsor's protocol ID
- HUHRD-SPE-16-09
- Status last verified
- Jun 2020
- First submitted
- 30 Dec 2016
- Last updated
- 25 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Tofacitinib in Korean Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT03011281
- Acronym / sponsor ID
- HUHRD-SPE-16-09
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 378 participants (estimated)
- Lead sponsor
- Hanyang UniversityUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 5 Jan 2017 (estimated)
- 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.
The objectives of this single center, prospective, non-interventional inception cohort is to understand patient characteristics, general treatment patterns, effectiveness, and safety of Tofacitinib for rheumatoid arthritis patients in the real-world setting.
- To evaluate the baseline characteristics of Korean RA patients treated with Tofacitinib
- To evaluate the effectiveness and safety of Tofacitinib in clinical practice in Korean RA patients.
- To further evaluate safety, effectiveness and demographic characteristics of the patients treated with Tofacitinib matched with and compared to biologic DMARDs from the BIOPSY registry database.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RA patients who start Tofacitinib | – | Drug: TofacitinibKorean RA patients who start Tofacitinib with moderately to severely active RA who have had an inadequate response or intolerance to methotrexate or biologics. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Korean RA patients who start Tofacitinib with moderately to severely active RA who have had an inadequate response or intolerance to methotrexate or biologics
Key inclusion criteria (2 listed)
- Patients who provide a written informed consent form of participating in this study.
- Patients who are more than 19 years old. C. Patients with moderately to severely active rheumatoid arthritis as defined per EULAR guidelines, who have had an inadequate response or are intolerant to methotrexate.
Key exclusion criteria (1 listed)
- Patients who do not provide a written informed consent form of participating in this study
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 |
|---|---|---|
| TofacitinibAlso: Xeljanz | Drug | RA patients who start Tofacitinib |
Primary outcome
DAS28-ESR (erythrocyte sedimentation rate) remission (DAS28 < 2.6) rate (%)
Time frame: 5 years
11 secondary outcomes
Assessment of efficacy with DAS28 (erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP))
Time frame: 5 years
Assessment of safety based on adverse events that occur during 5 years of patient monitoring.
Time frame: 5 years
Assessment of adherence with Patient-reported Adherence, and Medication Possession Ratio (MPR) at 24, 48, 72, 96, 120, 144, 168, 192, 216 and 240 weeks of clinical visit.
Time frame: 5 years
Assessment of Quality of life by European Quality of Life-5 Dimensions (EQ-5D)
Time frame: 5 years
Global Health assessment using Visual Analogue Scale (VAS)
Time frame: 5 years
Assessment of fatigue by Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue)
Time frame: 5 years
Assessment of sleep disturbance using Visual Analogue Scale (VAS)
Time frame: 5 years
Assessment of efficacy with Simple Disease Activity Index (SDAI)
Time frame: 5 years
Assessment of efficacy with Clinical Disease Activity Index (CDAI)
Time frame: 5 years
Assessment of efficacy with European League Against Rheumatism (EULAR) response Criteria
Time frame: 5 years
Assessment of Quality of life by Health Assessment Questionnaire Disability Index (HAQ-DI)
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- 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.
Yoon-Kyoung Sung, MD, PhD, MPH principal investigator
Hanyang University Hospital for Rheumatic Diseases
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, run by Hanyang University at 1 site in South Korea.
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: status not confirmed, as of the sponsor's last update on 25 Jun 2020. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yoon-Kyoung Sung, MD, PhD, MPH (82-2-2290-9250, sungyk@hanyang.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DAS28-ESR (erythrocyte sedimentation rate) remission (DAS28 < 2.6) rate (%) (time frame: 5 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 25 Jun 2020.