KOREAN POST-MARKETING SURVEILLANCE FOR XELJANZ XR (REGISTERED)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Pfizer
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Number of Participants With Treatment Emergent Adverse Events (AEs)
Study Overview
Brief 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. 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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •A. 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
Exclusion Criteria
- •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/mm
- •Patients with a lymphocyte count <500 cells/mm
- •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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change from baseline in Disease Activity Score based on 28-joints Count (DAS28)(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(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(Baseline, 52 weeks after treatment or within 30 days after last dose of medicinal product)
- Assessment of Ankylosing Spondylitis response (ASAS20)(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(Baseline, 52 weeks after treatment or within 30 days after last dose of medicinal product)