Active Moderate to Severe Rheumatoid ArthritisXRPMSNCT04876781
Korean Post-marketing Surveillance for Xeljanz XR
An observational study of Active Moderate to Severe Rheumatoid Arthritis and Active Ankylosing Spondylitis, run by Pfizer at 1 site in South Korea.
Trial summary
Xeljanz XR extended-release tablets 11 mg (Tofacitinib citrate) is a drug subject to the risk management plan in accordance with Article 4-1-11 of the "Regulation on Safety of Medicinal Products, etc." in Korea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Active Moderate to Severe Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis
- What is being tested?
- Tofacitinib XR
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jan 2022to 22 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Subjects administered with Xeljanz XR as a part of routine treatment who comply with the local labeling.
Who may be able to join
- Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- Xeljanz® XR is administered according to indications on the approved labeling
- Treatment of moderate to severe active RA in adult patients (18 years of age or older) who have had an inadequate response or are intolerant to methotrexate
- In combination with methotrexate, treatment of active psoriatic arthritis (PsA) in adult patients (18 years of age or older) who have had an inadequate response or who have been intolerant to a prior DMARD therapy.
- Treatment of active ankylosing spondylitis (AS) in adult patients (18 years of age or older) who have responded inadequately to conventional therapy
- In the following patients, Xeljanz® XR should be used only for patients who have had an inadequate response or are intolerant to the existing treatment.
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- Patients aged 65 or older B. Cardiovascular high-risk patients C. Patients at risk for malignancy
- Patients who have previously been given Xeljanz 5mg, who have changed Xeljanz® XR, are also eligible for registration in the study
- Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study
Who cannot join
- Patients meeting any of the following criteria will not be included in the study:
- Patients with a history of hypersensitivity to any ingredients of this product.
- Patients with serious infection (sepsis, etc.) or active infection including localized infection.
- Patients with active tuberculosis.
- Patients with severe hepatic function disorder.
- Patients with an absolute neutrophil count (ANC) <1,000 cells/mm3. *
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- Patients with a lymphocyte count <500 cells/mm3. *
- Patients with a hemoglobin level <9 g/dL. *
- Pregnant or possibly pregnant women. * Do not initiate Xeljanz XR in the following cases: ANC; absolute neutrophil count <1,000 cells/mm3 ALC; absolute lymphocyte count <500 cells/mm3 Hemoglobin<9 g/dL
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: KOREAN POST-MARKETING SURVEILLANCE FOR XELJANZ XR (REGISTERED)
Xeljanz XR extended-release tablets 11 mg (Tofacitinib citrate) is a drug subject to the risk management plan in accordance with Article 4-1-11 of the "Regulation on Safety of Medicinal Products, etc." in Korea. As part of additional pharmacovigilance activity, this Post-marketing Surveillance (PMS) was planned to evaluate safety and effectiveness of Xeljanz XR under routine clinical practice. At least 200 patients with Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis who were treated with Xeljanz XR will be enrolled about four years.
Read the detailed description
This is a open-label, non-comparative, non-interventional, prospective, and multi-center study to further evaluate the safety and effectiveness of Xeljianz XR in routine clinical practice in Korea.
Safety is the primary interest of this study, which will be assessed based on adverse events (AEs) that occur during the 6 months from the first dose of Xeljanz XR. The efficacy endpoints will be the modified Disease Activity Score using 28 joint counts (DAS28) change from baseline, European League Against Rheumatism (EULAR) response, and American College of Rheumatology 20% improvement criteria (ACR20) response after treatment.
- Conditions
- Active Moderate to Severe Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis
- Being tested
- Tofacitinib XR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tofacitinib XRDrug
Tofacitinib XR 11mg
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events (AEs)
AE is any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to end of this PMS after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Xeljanz XR was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Measured: Maximum of 52 weeks from the time of initial administration of Xeljanz XR
Secondary outcomes (5)
Change from baseline in Disease Activity Score based on 28-joints Count (DAS28)
DAS28, a modified version of the original Disease Activity Score (DAS), is a quantitative measure of disease activity used to monitor the treatment of RA.
Measured: Baseline, 52 weeks after treatment or within 30 days after last dose of medicinal product
Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28
The Disease Activity Score Based on 28-joints Count based (DAS28-based) EULAR response criteria is used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached.
Measured: Baseline, 52 weeks after treatment or within 30 days after last dose of medicinal product
Number of Participants With an American College of Rheumatology 20% (ACR20) Response
ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Measured: Baseline, 52 weeks after treatment or within 30 days after last dose of medicinal product
Assessment of Ankylosing Spondylitis response (ASAS20)
The ASAS Response Criteria (ASAS 20) is defined as an improvement of at least 20% and an absolute improvement of at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function (BASFI), and Inflammation (last 2 questions of BASDAI).
Measured: Baseline, 52 weeks after treatment or within 30 days after last dose of medicinal product
Changes from baseline in the number of tender joints and swollen joints
The number of tender joints and swollen joints, which are the specific components of the ACR20 response, are measured. The improvement from baseline after treatment is assessed.
Measured: Baseline, 52 weeks after treatment or within 30 days after last dose of medicinal product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start12 Jan 2022
- Primary completion22 Sep 2026 (estimated)
- Study completion22 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active Moderate to Severe Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876781
- Sponsor's protocol ID
- A3921369
- Other IDs
- NCT04876781
- Acronym
- XRPMS
- Status last verified
- Jul 2026
- First submitted
- 20 Apr 2021
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KOREAN POST-MARKETING SURVEILLANCE FOR XELJANZ XR (REGISTERED)
- ClinicalTrials.gov ID
- NCT04876781
- Acronym / sponsor ID
- XRPMS / A3921369
- Conditions
- Active Moderate to Severe Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 22 Sep 2026 (estimated)
- Study completion
- 22 Sep 2026 (estimated)
- First posted
- 6 May 2021 (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.
Xeljanz XR extended-release tablets 11 mg (Tofacitinib citrate) is a drug subject to the risk management plan in accordance with Article 4-1-11 of the "Regulation on Safety of Medicinal Products, etc." in Korea. As part of additional pharmacovigilance activity, this Post-marketing Surveillance (PMS) was planned to evaluate safety and effectiveness of Xeljanz XR under routine clinical practice. At least 200 patients with Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis who were treated with Xeljanz XR will be enrolled about four years.
Detailed description
This is a open-label, non-comparative, non-interventional, prospective, and multi-center study to further evaluate the safety and effectiveness of Xeljianz XR in routine clinical practice in Korea.
Safety is the primary interest of this study, which will be assessed based on adverse events (AEs) that occur during the 6 months from the first dose of Xeljanz XR. The efficacy endpoints will be the modified Disease Activity Score using 28 joint counts (DAS28) change from baseline, European League Against Rheumatism (EULAR) response, and American College of Rheumatology 20% improvement criteria (ACR20) response after treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects administered with Xeljanz XR as a part of routine treatment who comply with the local labeling.
Key inclusion criteria (9 listed)
- Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- Xeljanz® XR is administered according to indications on the approved labeling
- Patients who have previously been given Xeljanz 5mg, who have changed Xeljanz® XR, are also eligible for registration in the study
- Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study
Key exclusion criteria (9 listed)
- Patients with a history of hypersensitivity to any ingredients of this product.
- Patients with serious infection (sepsis, etc.) or active infection including localized infection.
- Patients with active tuberculosis.
- Patients with severe hepatic function disorder.
- Patients with an absolute neutrophil count (ANC) <1,000 cells/mm3. *
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 |
|---|---|---|
| Tofacitinib XRTofacitinib XR 11mg | Drug | – |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (AEs)
Time frame: Maximum of 52 weeks from the time of initial administration of Xeljanz XR
AE is any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to end of this PMS after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Xeljanz XR was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
5 secondary outcomes
Change from baseline in Disease Activity Score based on 28-joints Count (DAS28)
Time frame: Baseline, 52 weeks after treatment or within 30 days after last dose of medicinal product
Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28
Time frame: Baseline, 52 weeks after treatment or within 30 days after last dose of medicinal product
Number of Participants With an American College of Rheumatology 20% (ACR20) Response
Time frame: Baseline, 52 weeks after treatment or within 30 days after last dose of medicinal product
Assessment of Ankylosing Spondylitis response (ASAS20)
Time frame: Baseline, 52 weeks after treatment or within 30 days after last dose of medicinal product
Changes from baseline in the number of tender joints and swollen joints
Time frame: Baseline, 52 weeks after treatment or within 30 days after last dose of medicinal product
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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.
Pfizer CT.gov Call Center study director
Pfizer
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 Active Moderate to Severe Rheumatoid Arthritis and Active Ankylosing Spondylitis, run by Pfizer 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 9 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 3 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Emergent Adverse Events (AEs) (time frame: Maximum of 52 weeks from the time of initial administration of Xeljanz XR). 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 3 Aug 2026.