Rheumatoid ArthritisNCT02984020
Korean Post-marketing Surveillance for Xeljanz
An observational study of Rheumatoid Arthritis and Psoriatic Arthritis, run by Pfizer at 49 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Psoriatic Arthritis
- How many people
- 1,041 participants
- Where
- 49 sitesSouth Korea
- Study dates
- 13 May 2016to 9 Jun 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult rheumatoid arthritis or psoriatic arthritis taking tofacitinib within label as Ministry of Food and Drung Safety in Korea has approved
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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
Trial locations and contacts
49 sites in 1 country.
49 sites in 1 country
South Korea49 sites
Korea University Ansan Hospital
Ansan, Gyeonggi-do
Inje University Busan Paik hospital
Busan, 47392
Kosin University Gospel Hospital
Busan, 607-702
Inje University Haeundae Paik Hospital
Busan, 612-896
Soonchunhyang University Cheonan Hospital, Department of Rheumatology
Chunan-si, Chungcheongnam-do, 330-721
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, 24253
Chungbuk National University Hospital
Chungcheongbuk-do, 28644
Daegu Catholic University Medical Center, Department of Rheumatology
Daegu, 705-718
Eulji University Hospital, Internal Medicine, Rheumatology
Daejeon, 302-799
Chosun University Hospital, Rheumatism Department
Donggu, Gwang JU, 61453
Yongin Severance Hospital
Giheung-gu, Yongin-si, Gyeonggi-do
Myongji Hospital / Rheumatology
Goyang-si, Deogyang-gu, 10475
Inje University IlsanPaik Hospital
Goyang-si, Gyeonggi-do
Dongguk University Ilsan Medical Center
Gyeonggi-do
Wonkwang University Hospital / Division of Rheumatology
Iksan, Jeonlabuk-do, 570711
Gachon University Gil Hospital
Incheon, 405-760
Division of Rheumatology
Incheon
Jeju National University Hospital
Jeju Special Self-Goverming Province
Chonbuk National University Hospital, Department of Rheumatology
Jeonju, Jeollabuk-do, 561-712
Keimyung University Dongsan Medical Center
Jung-Gu, Daegu, 700-712
Division of Rheumatology
Metropolitan City, Daejeon
Pusan National University Hospital
Pusan, 602-739
Dong-A University Hospital
Pusan
Kongyang University Hospital / Rheumatology
Seogu, Daejon, 35365
Division of Rheumatology
Seongnam-si, Gyeongg-do
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, 13496
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Kyung Hee University Hospital at Gangdong / Rheumatology
Seoul, Gangdong-gu, 05278
VHS Medical Center / Rheumatologist
Seoul, Gangdong-gu, 05367
Hanyang Rheuma Uhm Wan-Sik Clinic
Seoul, 04782
Division of Rheumatology, SMG-SNU Boramae Medical Center
Seoul, 07061
Seoul National University Hospital, Department of Internal Medicine
Seoul, 110-744
Seoul National University Hospital, Rheumatology, Internal Medicine
Seoul, 110-744
Kyung Hee University Hospital
Seoul, 130-872
Hanyang University Hospital, Department of Rheumatology
Seoul, 133-792
Kyunghee University East-West Neo Medical Center, 149 Sangil-dong, Gangdong-gu
Seoul, 134-890
Samsung Medical Center, Division of Rheumatology, Department of Medicine
Seoul, 135-710
The Catholic University of Korea, Kangnam St. Mary's Hospital/ Rheumatology, Internal Medicine
Seoul, 137-701
The Catholic University of Korea, Seoul St. Mary's Hospital/ Rheumatology, Internal Medicine
Seoul, 137-701
Eulji Medical Center
Seoul, 139-711
Soonchunhyang University Hospital Seoul/Department of Rheumatology
Seoul, 140-887
Konkuk University Medical Center
Seoul, 143-729
Division of Rheumatology
Seoul
Ewha Womans University Mokdong Hospital
Seoul
Hallym University Kangnam Sacred Heart Hospital
Seoul
Kyung Hee University Medical Center
Seoul
Ajou University Hospital, Department of Rheumatology
Suwon, Kyeongki-do, 442-712
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612
Yangsan Hospital-Pusan National University
Yangsan, Gyeongsangnam-do, 50612
About this study
Official title: Korean Post-marketing Surveillance for Xeljanz(Registered) in Rheumatoid Arthritis and Psoriatic Arthritis Patients
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.
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Psoriatic
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
DAS28 is a modified version of the original Disease Activity Score (DAS). It is a quantitative measure of disease activity used to monitor the treatment or RA. DAS28 (erythrocyte sedimentation rate [ESR]) was calculated from: DAS28 (ESR) = 0.56*√(tender joint counter [TJC] 28) + 0.28*√(swollen joint count [SJC] 28) + 0.014*VAS+ 0.70*ln(ESR), where VAS = visual analogue scale. Total score range: 0-9.4, higher score=more disease activity.
Measured: From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)
Change From Baseline in DAS28 (CRP)
DAS28 is a modified version of the original Disease Activity Score (DAS). It is a quantitative measure of disease activity used to monitor the treatment or RA. DAS28-3 ( C-reactive protein [CRP]) was calculated from the swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity.
Measured: From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)
Number of Participants With EULAR Response
European League Against Rheumatism (EULAR) response is a DAS-based response criteria that classifies individual participants as none, moderate, or good responders, depending on the extent of change and the level of disease activity reached. Participants with improvement in DAS28 from baseline >1.2 and DAS28 based EULAR <=3.2 were good responders; participants with improvement in DAS28 from baseline >0.6 and <=1.2 and DAS28 based EULAR >3.2 and <=5.1 were moderate responders; participants with improvement in DAS28 from baseline <=0.6 and DAS28-based EULAR >5.1 were none responders.
Measured: 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
ACR20 response: ≥20% 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 CRP.
Measured: From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)
Number of Participants With Effectiveness
The variables included DAS28, EULAR response, and ACR20 response. The investigator made the assessment of the overall effectiveness as improved, no change, or aggravated, based on each test results and clinical judgment. No change and aggravated were classified as ineffective.
Measured: From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)
Number of Participants With Effectiveness by Demographic Characteristics
The variables included DAS28, EULAR response, and ACR20 response. The investigator made the assessment of the overall effectiveness as improved, no change, or aggravated, based on each test results and clinical judgment.
Measured: 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
The variables included DAS28, EULAR response, and ACR20 response. The investigator made the assessment of the overall effectiveness as improved, no change, or aggravated, based on each test results and clinical judgment. Logistic regression analysis of multivariate analysis was performed and presented as odds ratios with 95% confidence interval to identify the factors that affected classified overall assessment (effective/ineffective) in demography and baseline characteristics of the participants.
Measured: From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study start13 May 2016
- Primary completion9 Jun 2022
- Study completion9 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,041 participants (actual)
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
- NCT02984020
- Sponsor's protocol ID
- A3921249
- Status last verified
- Aug 2024
- First submitted
- 3 Nov 2016
- Last updated
- 27 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Korean Post-marketing Surveillance for Xeljanz(Registered) in Rheumatoid Arthritis and Psoriatic Arthritis Patients
- ClinicalTrials.gov ID
- NCT02984020
- Acronym / sponsor ID
- A3921249
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,041 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 13 May 2016 (actual)
- Primary completion
- 9 Jun 2022 (actual)
- Study completion
- 9 Jun 2022 (actual)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Posted 27 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult rheumatoid arthritis or psoriatic arthritis taking tofacitinib within label as Ministry of Food and Drung Safety in Korea has approved
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs)
Time frame: 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.
Number of Participants With Unexpected AEs, Unexpected SAEs, Unexpected ADRs and Unexpected SADRs
Time frame: 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.
Duration of Adverse Events
Time frame: 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 Severity
Time frame: 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
Time frame: 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 Seriousness Criteria
Time frame: 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 by Their Action Taken With Regard to Xeljanz
Time frame: 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 Causality to Xeljanz
Time frame: 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 Demographic Characteristics
Time frame: 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 According to Other Baseline Characteristics
Time frame: 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 - Multivariate Logistic Regression Analysis
Time frame: 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 Geriatric Participants With Adverse Events and Adverse Drug Reactions
Time frame: 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.
Number of Participants With Adverse Events and Adverse Drug Reactions - Renal Disorder
Time frame: 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
Time frame: 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
Time frame: 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.
7 secondary outcomes
Change From Baseline in DAS28 (ESR)
Time frame: From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)
Change From Baseline in DAS28 (CRP)
Time frame: From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)
Number of Participants With EULAR Response
Time frame: 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
Time frame: From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)
Number of Participants With Effectiveness
Time frame: From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)
Number of Participants With Effectiveness by Demographic Characteristics
Time frame: 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
Time frame: From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
49 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Psoriatic Arthritis, run by Pfizer at 49 sites 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 1 inclusion and 10 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: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites 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?
Yes. Results are posted in the registry (first posted 27 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs) (time frame: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)). The study lists 15 primary outcomes in all. 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 27 Aug 2024.