Actively Recruiting
Korean Post-marketing Surveillance for Xeljanz XR
Led by Pfizer · Updated on 2026-03-27
200
Participants Needed
1
Research Sites
232 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Korean Post-marketing Surveillance for Xeljanz XR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Xeljanz XR must be used according to approved indications
- Adults aged 18 years or older with moderate to severe active Rheumatoid Arthritis who had inadequate response or intolerance to methotrexate
- Adults aged 18 years or older with active Psoriatic Arthritis treated with methotrexate who had inadequate response or intolerance to prior DMARD therapy
- Adults aged 18 years or older with active Ankylosing Spondylitis who responded inadequately to conventional therapy
- Use of Xeljanz XR only for patients aged 65 or older, cardiovascular high-risk patients, or patients at risk for malignancy after inadequate response or intolerance to existing treatment
- Patients previously treated with Xeljanz 5mg who have switched to Xeljanz XR
- Signed informed consent obtained
You will not qualify if you...
- History of hypersensitivity to any ingredient of Xeljanz XR
- Serious or active infection including sepsis or localized infections
- Active tuberculosis
- Severe liver function disorder
- Absolute neutrophil count below 1,000 cells/mm3
- Lymphocyte count below 500 cells/mm3
- Hemoglobin level below 9 g/dL
- Pregnant or possibly pregnant women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Pfizer
Seoul, South Korea
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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