Korean Post-marketing Surveillance for Xeljanz
1 other identifier
observational
1,041
1 country
49
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2016
Longer than P75 for all trials
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 13, 2016
CompletedFirst Submitted
Initial submission to the registry
November 3, 2016
CompletedFirst Posted
Study publicly available on registry
December 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 9, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 9, 2022
CompletedResults Posted
Study results publicly available
August 27, 2024
CompletedAugust 27, 2024
August 1, 2024
6.1 years
November 3, 2016
May 19, 2023
August 22, 2024
Conditions
Outcome Measures
Primary Outcomes (15)
Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs)
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.
From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Number of Participants With Unexpected AEs, Unexpected SAEs, Unexpected ADRs and Unexpected SADRs
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.
From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Duration of Adverse Events
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.
From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Number of Participants With Adverse Events by Their Severity
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.
From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Number of Participants With Adverse Events by Their Outcome
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.
From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Number of Participants With Adverse Events by Their Seriousness Criteria
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.
From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Number of Participants With Adverse Events by Their Action Taken With Regard to Xeljanz
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.
From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Number of Participants With Adverse Events by Their Causality to Xeljanz
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.
From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Number of Participants With Adverse Events According to Demographic Characteristics
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.
From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Number of Participants With Adverse Events According to Other Baseline Characteristics
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.
From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Number of Participants With Adverse Events - Multivariate Logistic Regression Analysis
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.
From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Number of Geriatric Participants With Adverse Events and Adverse Drug Reactions
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.
From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Number of Participants With Adverse Events and Adverse Drug Reactions - Renal Disorder
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.
From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Number of Participants With Adverse Events and Adverse Drug Reactions - Hepatic Disorder
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.
From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Number of Participants With Adverse Events and Adverse Drug Reactions - Other Than Safety Analysis Population
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.
From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Secondary Outcomes (7)
Change From Baseline in DAS28 (ESR)
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 EULAR Response
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)
- +2 more secondary outcomes
Eligibility Criteria
adult rheumatoid arthritis or psoriatic arthritis taking tofacitinib within label as Ministry of Food and Drung Safety in Korea has approved
You may qualify if:
- 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)
You may not qualify if:
- 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/mm3.
- Patients with a lymphocyte count \<500 cells/mm3.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (49)
Soonchunhyang University Cheonan Hospital, Department of Rheumatology
Chunan-si, Chungcheongnam-do, 330-721, South Korea
Keimyung University Dongsan Medical Center
Jung-Gu, Daegu, 700-712, South Korea
Kongyang University Hospital / Rheumatology
Seogu, Daejon, 35365, South Korea
Myongji Hospital / Rheumatology
Goyang-si, Deogyang-gu, 10475, South Korea
Kyung Hee University Hospital at Gangdong / Rheumatology
Seoul, Gangdong-gu, 05278, South Korea
VHS Medical Center / Rheumatologist
Seoul, Gangdong-gu, 05367, South Korea
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, 24253, South Korea
Chosun University Hospital, Rheumatism Department
Donggu, Gwang JU, 61453, South Korea
Division of Rheumatology
Seongnam-si, Gyeongg-do, South Korea
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, 13496, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612, South Korea
Yangsan Hospital-Pusan National University
Yangsan, Gyeongsangnam-do, 50612, South Korea
Chonbuk National University Hospital, Department of Rheumatology
Jeonju, Jeollabuk-do, 561-712, South Korea
Wonkwang University Hospital / Division of Rheumatology
Iksan, Jeonlabuk-do, 570711, South Korea
Ajou University Hospital, Department of Rheumatology
Suwon, Kyeongki-do, 442-712, South Korea
Korea University Ansan Hospital
Ansan, Gyeonggi-do, South Korea
Inje University Busan Paik hospital
Busan, 47392, South Korea
Kosin University Gospel Hospital
Busan, 607-702, South Korea
Inje University Haeundae Paik Hospital
Busan, 612-896, South Korea
Chungbuk National University Hospital
Chungcheongbuk-do, 28644, South Korea
Daegu Catholic University Medical Center, Department of Rheumatology
Daegu, 705-718, South Korea
Eulji University Hospital, Internal Medicine, Rheumatology
Daejeon, 302-799, South Korea
Yongin Severance Hospital
Giheung-gu, Yongin-si, Gyeonggi-do, South Korea
Inje University IlsanPaik Hospital
Goyang-si, Gyeonggi-do, South Korea
Dongguk University Ilsan Medical Center
Gyeonggi-do, South Korea
Gachon University Gil Hospital
Incheon, 405-760, South Korea
Division of Rheumatology
Incheon, South Korea
Jeju National University Hospital
Jeju Special Self-Goverming Province, South Korea
Division of Rheumatology
Metropolitan City, Daejeon, South Korea
Pusan National University Hospital
Pusan, 602-739, South Korea
Dong-A University Hospital
Pusan, South Korea
Hanyang Rheuma Uhm Wan-Sik Clinic
Seoul, 04782, South Korea
Division of Rheumatology, SMG-SNU Boramae Medical Center
Seoul, 07061, South Korea
Seoul National University Hospital, Department of Internal Medicine
Seoul, 110-744, South Korea
Seoul National University Hospital, Rheumatology, Internal Medicine
Seoul, 110-744, South Korea
Kyung Hee University Hospital
Seoul, 130-872, South Korea
Hanyang University Hospital, Department of Rheumatology
Seoul, 133-792, South Korea
Kyunghee University East-West Neo Medical Center, 149 Sangil-dong, Gangdong-gu
Seoul, 134-890, South Korea
Samsung Medical Center, Division of Rheumatology, Department of Medicine
Seoul, 135-710, South Korea
The Catholic University of Korea, Kangnam St. Mary's Hospital/ Rheumatology, Internal Medicine
Seoul, 137-701, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital/ Rheumatology, Internal Medicine
Seoul, 137-701, South Korea
Eulji Medical Center
Seoul, 139-711, South Korea
Soonchunhyang University Hospital Seoul/Department of Rheumatology
Seoul, 140-887, South Korea
Konkuk University Medical Center
Seoul, 143-729, South Korea
Division of Rheumatology
Seoul, South Korea
Ewha Womans University Mokdong Hospital
Seoul, South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, South Korea
Kyung Hee University Medical Center
Seoul, South Korea
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2016
First Posted
December 6, 2016
Study Start
May 13, 2016
Primary Completion
June 9, 2022
Study Completion
June 9, 2022
Last Updated
August 27, 2024
Results First Posted
August 27, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share
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.