Korean Post-marketing Surveillance for Xeljanz(Registered) in Rheumatoid Arthritis and Psoriatic Arthritis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,041
- 试验地点
- 46
- 主要终点
- Number of Participants With Unexpected AEs, Unexpected SAEs, Unexpected ADRs and Unexpected SADRs
研究概览
简要总结
The objective of this study is to identify any problems and questions with respect to the safety and efficacy of Xeljanz during the post-marketing period as required by the regulation of MFDS.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be included in the study all patients will have received at least 1 dose of Xeljanz for the treatment of the following indication as per local labelling. Moderately to severely active RA in adult patients who have had an inadequate response or intolerance to previous therapy with at least 1 biological DMARD. Or Active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to previous antirheumatic drugs (DMARDs)
排除标准
- •Patients with a history of hypersensitivity to any ingredients of the product.
- •Patients with serious infection (eg, sepsis) or active infection including localized infection.
- •Patients with active tuberculosis.
- •Patients with severe hepatic function disorder.
- •Patients with an absolute neutrophil count (ANC) <500 cells/mm
- •Patients with a lymphocyte count <500 cells/mm
- •Patients with a hemoglobin concentration <8 g/dL.
- •Pregnant or possibly pregnant women.
- •Because of lactose contained in this drug, it should not be administered to patients with hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- •According to Contraindication on label, the investigator should discontinue the patient's treatment if the laboratory test results are as below Patients with an absolute neutrophil count (ANC) <500 cells/mm3 Patients with a hemoglobin level <8 g/dL
结局指标
主要结局
Number of Participants With Unexpected AEs, Unexpected SAEs, Unexpected ADRs and Unexpected SADRs
时间窗: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. SAE was any untoward medical occurrence that at any dose resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. SADR was any SAE that is attributed to Xeljanz. Relatedness to Xeljanz was assessed by the physician. An unexpected AE was an AE with a difference in nature, severity, specificity, or outcome, compared to the product licensure/safety notification of the drug. Unexpected ADRs were unexpected AEs that were, in the investigator's opinion, of causal relationship to the study treatment.
Number of Participants With Adverse Events by Their Severity
时间窗: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
The evaluation of AE severity was done according to the following categories: mild: not causing any significant problem to the participant. Administration of medicinal product continues without dose adjustment. Moderate: causes a problem that dose not interfere significantly with usual activities or the clinical status. Dose of the medical product is adjusted or other therapy is added due to the AE. Severe: causes a problem that interferes significantly with usual activities or the clinical status. The medicinal product is stopped due to the AE. Only participants with available severity assessment data are reported.
Number of Participants With Adverse Events by Their Outcome
时间窗: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. The outcomes of AE included recovered, recovered with sequelae, recovering, not recovered and unknown. One participant may experience more than one event hence one participant may be included in more than one category specified below. Only participants with available outcome assessment are reported.
Number of Participants With Adverse Events by Their Action Taken With Regard to Xeljanz
时间窗: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship. The action taken with regard to the medicinal product included: permanently discontinued, temporarily discontinued or delayed, dose reduced, dose increased, no change, not applicable. Only participants with available action taken assessment data are reported.
Number of Participants With Adverse Events by Their Seriousness Criteria
时间窗: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. The seriousness criteria for AEs included results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, results in congenital anomaly/birth defect, other important medical event. Only participants with available seriousness assessment data are reported.
Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs)
时间窗: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. SAE was any untoward medical occurrence that at any dose resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. SADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to Xeljanz was assessed by the physician.
Duration of Adverse Events
时间窗: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. Only participants with available data are reported.
Number of Participants With Adverse Events by Their Causality to Xeljanz
时间窗: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship. The causality of AEs to Xeljanz were assessed by physician according to the following criteria: certain, probable/likely, possible, unlikely, conditional/unclassified and unassessible/unclassifiable. One participant may experience more than one event hence, one participant may be included in more than one category specified below. Only participants with available causality assessment data are reported.
Number of Participants With Adverse Events According to Other Baseline Characteristics
时间窗: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Other baseline characteristics included: indication; duration of the disease; severity of disease; radiologic progression; status of latent tuberculosis; herpes zoster vaccination; smoking; prior rheumatoid arthritis therapy; medical history; renal disorder; hepatic disorder; allergic history; concomitant medication; duration of administration. Only participants with available other baseline characteristics and AE assessment data are reported.
Number of Participants With Adverse Events According to Demographic Characteristics
时间窗: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. Number of participants with AEs classified according to the following demographic characteristics: sex: male and female; age: less than (\<) 40 years, greater than or equal to (\>=) 40 and \< 50 years and \>= 50 years and \<60 years; \>= 60 and \<70 years; geriatric (\>=65 years). Only participants with available demographic and AE assessment data are reported.
Number of Participants With Adverse Events - Multivariate Logistic Regression Analysis
时间窗: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. Logistic regression analysis of multivariate analysis was performed and presented an odds ratio with 95% confidence interval to identify the factors that affect occurrence of AEs in demography and baseline characteristics, or concomitant treatment status, etc.
Number of Participants With Adverse Events and Adverse Drug Reactions - Renal Disorder
时间窗: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. Renal disorder was judged by the investigator.
Number of Participants With Adverse Events and Adverse Drug Reactions - Hepatic Disorder
时间窗: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. Hepatic disorder was judged by the investigator.
Number of Participants With Adverse Events and Adverse Drug Reactions - Other Than Safety Analysis Population
时间窗: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. AEs and ADRs for participants excluded from the safety analysis population were reported. The reason for exclusion included: not met the inclusion criteria/met exclusion criteria; off-label use; other significant protocol violation.
Number of Geriatric Participants With Adverse Events and Adverse Drug Reactions
时间窗: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz.
次要结局
- Change From Baseline in DAS28 (ESR)(From Baseline to 6 months after treatment (through study completion, up to approximately 6 years))
- Number of Participants With EULAR Response(From Baseline to 6 months after treatment (through study completion, up to approximately 6 years))
- Change From Baseline in DAS28 (CRP)(From Baseline to 6 months after treatment (through study completion, up to approximately 6 years))
- Number of Participants With Effectiveness by Demographic Characteristics(From Baseline to 6 months after treatment (through study completion, up to approximately 6 years))
- Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Month 6(From Baseline to 6 months after treatment (through study completion, up to approximately 6 years))
- Number of Participants With Effectiveness(From Baseline to 6 months after treatment (through study completion, up to approximately 6 years))
- Number of Participants With Improved Effectiveness - Multivariate Logistic Regression Analysis(From Baseline to 6 months after treatment (through study completion, up to approximately 6 years))