Clinical trial NCT02984020: Korean Post-marketing Surveillance for Xeljanz
Official title: Korean Post-marketing Surveillance for Xeljanz(Registered) in Rheumatoid Arthritis and Psoriatic Arthritis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Psoriatic Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2016-12-06
Enrollment: 1041
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult rheumatoid arthritis or psoriatic arthritis taking tofacitinib within label as Ministry of Food and Drung Safety in Korea has approved

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.


Eligibility criteria: Inclusion Criteria:

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)

Exclusion Criteria:

1. Patients with a history of hypersensitivity to any ingredients of the product.
2. Patients with serious infection (eg, sepsis) or active infection including localized infection.
3. Patients with active tuberculosis.
4. Patients with severe hepatic function disorder.
5. Patients with an absolute neutrophil count (ANC) \<500 cells/mm3.
6. Patients with a lymphocyte count \<500 cells/mm3.
7. Patients with a hemoglobin concentration \<8 g/dL.
8. Pregnant or possibly pregnant women.
9. 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

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs)
timeFrame: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
measure: Number of Participants With Unexpected AEs, Unexpected SAEs, Unexpected ADRs and Unexpected SADRs
timeFrame: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
measure: Duration of Adverse Events
timeFrame: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
measure: Number of Participants With Adverse Events by Their Severity
timeFrame: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
measure: Number of Participants With Adverse Events by Their Outcome
timeFrame: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
measure: Number of Participants With Adverse Events by Their Seriousness Criteria
timeFrame: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
measure: Number of Participants With Adverse Events by Their Action Taken With Regard to Xeljanz
timeFrame: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
measure: Number of Participants With Adverse Events by Their Causality to Xeljanz
timeFrame: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
measure: Number of Participants With Adverse Events According to Demographic Characteristics
timeFrame: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
measure: Number of Participants With Adverse Events According to Other Baseline Characteristics
timeFrame: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
measure: Number of Participants With Adverse Events - Multivariate Logistic Regression Analysis
timeFrame: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
measure: Number of Geriatric Participants With Adverse Events and Adverse Drug Reactions
timeFrame: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
measure: Number of Participants With Adverse Events and Adverse Drug Reactions - Renal Disorder
timeFrame: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
measure: Number of Participants With Adverse Events and Adverse Drug Reactions - Hepatic Disorder
timeFrame: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
measure: Number of Participants With Adverse Events and Adverse Drug Reactions - Other Than Safety Analysis Population
timeFrame: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Secondary outcomes:
measure: Change From Baseline in DAS28 (ESR)
timeFrame: From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)
measure: Change From Baseline in DAS28 (CRP)
timeFrame: From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)
measure: Number of Participants With EULAR Response
timeFrame: From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)
measure: Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Month 6
timeFrame: From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)
measure: Number of Participants With Effectiveness
timeFrame: From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)
measure: Number of Participants With Effectiveness by Demographic Characteristics
timeFrame: From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)
measure: Number of Participants With Improved Effectiveness - Multivariate Logistic Regression Analysis
timeFrame: From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)
Other outcomes:
Locations:
city: Chonju
country: Korea, Republic of
facility: Chonbuk National University Hospital, Department of Rheumatology
state: Chonbuk
city: Chunan-si
country: Korea, Republic of
facility: Soonchunhyang University Cheonan Hospital, Department of Rheumatology
state: Chungcheongnam-do
city: Jung-Gu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
state: Daegu
city: Seo-gu
country: Korea, Republic of
facility: Kongyang University Hospital / Rheumatology
state: Daejon
city: Goyang-si
country: Korea, Republic of
facility: Myongji Hospital / Rheumatology
state: Deogyang-gu
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong / Rheumatology
state: Gangdong-gu
city: Seoul
country: Korea, Republic of
facility: VHS Medical Center / Rheumatologist
state: Gangdong-gu
city: Chuncheon-si
country: Korea, Republic of
facility: Hallym University Chuncheon Sacred Heart Hospital
state: Gangwon-do
city: Dong Gu
country: Korea, Republic of
facility: Chosun University Hospital, Rheumatism Department
state: Gwang JU
city: Seongnam-si
country: Korea, Republic of
facility: Division of Rheumatology
state: Gyeongg-do
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Yangsan-si
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeongsangnam-do
city: Yangsan-si
country: Korea, Republic of
facility: Yangsan Hospital-Pusan National University
state: Gyeongsangnam-do
city: Iksan
country: Korea, Republic of
facility: Wonkwang University Hospital / Division of Rheumatology
state: Jeonlabuk-do
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital, Department of Rheumatology
state: Kyeongki-do
city: Ansan, Gyeonggi-do
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik hospital
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Chungcheongbuk-do
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center, Department of Rheumatology
city: Daejeon
country: Korea, Republic of
facility: Eulji University Hospital, Internal Medicine, Rheumatology
city: Giheung-gu, Yongin-si, Gyeonggi-do
country: Korea, Republic of
facility: Yongin Severance Hospital
city: Goyang-si, Gyeonggi-do
country: Korea, Republic of
facility: Inje University IlsanPaik Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Dongguk University Ilsan Medical Center
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Incheon
country: Korea, Republic of
facility: Division of Rheumatology
city: Jeju Special Self-Goverming Province
country: Korea, Republic of
facility: Jeju National University Hospital
city: Metropolitan City, Daejeon
country: Korea, Republic of
facility: Division of Rheumatology
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Pusan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang Rheuma Uhm Wan-Sik Clinic
city: Seoul
country: Korea, Republic of
facility: Division of Rheumatology, SMG-SNU Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital, Department of Internal Medicine
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital, Rheumatology, Internal Medicine
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital, Department of Rheumatology
city: Seoul
country: Korea, Republic of
facility: Kyunghee University East-West Neo Medical Center, 149 Sangil-dong, Gangdong-gu
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center, Division of Rheumatology, Department of Medicine
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Kangnam St. Mary's Hospital/ Rheumatology, Internal Medicine
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital/ Rheumatology, Internal Medicine
city: Seoul
country: Korea, Republic of
facility: Eulji Medical Center
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Hospital Seoul/Department of Rheumatology
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Division of Rheumatology
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Medical Center
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: