Korean Post-marketing Surveillance for Xeljanz

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 19 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02984020
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Pfizer
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Pfizer CT.gov Call Center
Principal Investigator Affiliation Pfizer
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Korea, Republic of
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rheumatoid Arthritis, Psoriatic Arthritis
Study Website: View Trial Website

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Chonju, Chonbuk, Korea, Republic of

Status

Recruiting

Address

Chonbuk National University Hospital, Department of Rheumatology

Chonju, Chonbuk, 561-712

Dankook University Hospotal, Cheonan, Chung NAM, Korea, Republic of

Status

Recruiting

Address

Dankook University Hospotal

Cheonan, Chung NAM, 31116

Chunan-si, Chungcheongnam-do, Korea, Republic of

Status

Recruiting

Address

Soonchunhyang University Cheonan Hospital, Department of Rheumatology

Chunan-si, Chungcheongnam-do, 330-721

Jung-Gu, Daegu, Korea, Republic of

Status

Recruiting

Address

Keimyung University Dongsan Medical Center

Jung-Gu, Daegu, 700-712

Seo-gu, Daejon, Korea, Republic of

Status

Recruiting

Address

Kongyang University Hospital / Rheumatology

Seo-gu, Daejon, 35365

Seoul, Gangdong-gu, Korea, Republic of

Status

Recruiting

Address

Kyung Hee University Hospital at Gangdong / Rheumatology

Seoul, Gangdong-gu, 05278

VHS Medical Center / Rheumatologist, Seoul, Gangdong-gu, Korea, Republic of

Status

Recruiting

Address

VHS Medical Center / Rheumatologist

Seoul, Gangdong-gu, 05367

Dong Gu, Gwang JU, Korea, Republic of

Status

Recruiting

Address

Chosun University Hospital, Rheumatism Department

Dong Gu, Gwang JU, 61453

Division of Rheumatology, Seongnam-si, Gyeongg-do, Korea, Republic of

Status

Recruiting

Address

Division of Rheumatology

Seongnam-si, Gyeongg-do,

CHA Bundang Medical Center, Seongnam-si, Gyeonggi-do, Korea, Republic of

Status

Recruiting

Address

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, 13496

Yangsan-si, Gyeongsangnam-do, Korea, Republic of

Status

Recruiting

Address

Pusan National University Yangsan Hospital

Yangsan-si, Gyeongsangnam-do, 50612

Yangsan-si, Gyeongsangnam-do, Korea, Republic of

Status

Recruiting

Address

Yangsan Hospital-Pusan National University

Yangsan-si, Gyeongsangnam-do, 50612

Iksan, Jeonlabuk-do, Korea, Republic of

Status

Recruiting

Address

Wonkwang University Hospital / Division of Rheumatology

Iksan, Jeonlabuk-do, 570711

Suwon-si, Kyeongki-do, Korea, Republic of

Status

Recruiting

Address

Ajou University Hospital, Department of Rheumatology

Suwon-si, Kyeongki-do, 442-712

Korea University Ansan Hospital, Ansan, Gyeonggi-do, Korea, Republic of

Status

Recruiting

Address

Korea University Ansan Hospital

Ansan, Gyeonggi-do, ,

Inje University Busan Paik hospital, Busan, Korea, Republic of

Status

Recruiting

Address

Inje University Busan Paik hospital

Busan, , 47392

Kosin University Gospel Hospital, Busan, Korea, Republic of

Status

Recruiting

Address

Kosin University Gospel Hospital

Busan, , 607-702

Inje University Haeundae Paik Hospital, Busan, Korea, Republic of

Status

Recruiting

Address

Inje University Haeundae Paik Hospital

Busan, , 612-896

Chungbuk National University Hospital, Chungcheongbuk-do, Korea, Republic of

Status

Recruiting

Address

Chungbuk National University Hospital

Chungcheongbuk-do, , 28644

Daegu, Korea, Republic of

Status

Recruiting

Address

Daegu Catholic University Medical Center, Department of Rheumatology

Daegu, , 705-718

Daejeon, Korea, Republic of

Status

Recruiting

Address

Eulji University Hospital, Internal Medicine, Rheumatology

Daejeon, , 302-799

Inje University IlsanPaik Hospital, Goyang-si, Gyeonggi-do, Korea, Republic of

Status

Recruiting

Address

Inje University IlsanPaik Hospital

Goyang-si, Gyeonggi-do, ,

Dongguk University Ilsan Medical Center, Gyeonggi-do, Korea, Republic of

Status

Recruiting

Address

Dongguk University Ilsan Medical Center

Gyeonggi-do, ,

Gachon University Gil Hospital, Incheon, Korea, Republic of

Status

Recruiting

Address

Gachon University Gil Hospital

Incheon, , 405-760

Division of Rheumatology, Incheon, Korea, Republic of

Status

Recruiting

Address

Division of Rheumatology

Incheon, ,

Jeju National University Hospital, Jeju Special Self-Goverming Province, Korea, Republic of

Status

Recruiting

Address

Jeju National University Hospital

Jeju Special Self-Goverming Province, ,

Division of Rheumatology, Metropolitan City, Daejeon, Korea, Republic of

Status

Recruiting

Address

Division of Rheumatology

Metropolitan City, Daejeon, ,

Pusan National University Hospital, Pusan, Korea, Republic of

Status

Recruiting

Address

Pusan National University Hospital

Pusan, , 602-739

Dong-A University Hospital, Pusan, Korea, Republic of

Status

Recruiting

Address

Dong-A University Hospital

Pusan, ,

Hanyang Rheuma Uhm Wan-Sik Clinic, Seoul, Korea, Republic of

Status

Terminated

Address

Hanyang Rheuma Uhm Wan-Sik Clinic

Seoul, , 04782

Seoul, Korea, Republic of

Status

Recruiting

Address

Division of Rheumatology, SMG-SNU Boramae Medical Center

Seoul, , 07061

Seoul, Korea, Republic of

Status

Recruiting

Address

Seoul National University Hospital, Department of Internal Medicine

Seoul, , 110-744

Seoul, Korea, Republic of

Status

Recruiting

Address

Seoul National University Hospital, Rheumatology, Internal Medicine

Seoul, , 110-744

Seoul, Korea, Republic of

Status

Not yet recruiting

Address

Seoul National University Hospital, Rheumatology, Internal Medicine

Seoul, , 110-744

Kyung Hee University Hospital, Seoul, Korea, Republic of

Status

Recruiting

Address

Kyung Hee University Hospital

Seoul, , 130-872

Seoul, Korea, Republic of

Status

Recruiting

Address

Hanyang University Hospital, Department of Rheumatology

Seoul, , 133-792

Seoul, Korea, Republic of

Status

Recruiting

Address

Kyunghee University East-West Neo Medical Center, 149 Sangil-dong, Gangdong-gu

Seoul, , 134-890

Seoul, Korea, Republic of

Status

Recruiting

Address

Samsung Medical Center, Division of Rheumatology, Department of Medicine

Seoul, , 135-710

Seoul, Korea, Republic of

Status

Recruiting

Address

The Catholic University of Korea, Kangnam St. Mary's Hospital/ Rheumatology, Internal Medicine

Seoul, , 137-701

Seoul, Korea, Republic of

Status

Recruiting

Address

The Catholic University of Korea, Seoul St. Mary's Hospital/ Rheumatology, Internal Medicine

Seoul, , 137-701

Eulji Medical Center, Seoul, Korea, Republic of

Status

Recruiting

Address

Eulji Medical Center

Seoul, , 139-711

Seoul, Korea, Republic of

Status

Recruiting

Address

Soonchunhyang University Hospital Seoul/Department of Rheumatology

Seoul, , 140-887

Konkuk University Medical Center, Seoul, Korea, Republic of

Status

Recruiting

Address

Konkuk University Medical Center

Seoul, , 143-729

Division of Rheumatology, Seoul, Korea, Republic of

Status

Recruiting

Address

Division of Rheumatology

Seoul, ,

Ewha Womans University Mokdong Hospital, Seoul, Korea, Republic of

Status

Recruiting

Address

Ewha Womans University Mokdong Hospital

Seoul, ,

Seoul, Korea, Republic of

Status

Active, not recruiting

Address

Hallym University Kangnam Sacred Heart Hospital

Seoul, ,

Kyung Hee University Medical Center, Seoul, Korea, Republic of

Status

Recruiting

Address

Kyung Hee University Medical Center

Seoul, ,

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